Showing source for: https://listnauru.blogspot.com/
Duration: 0.426275s
Server: GSE

<!DOCTYPE html>
<html class="v2" dir="ltr" lang="en">
    <head>
        <link href="https://www.blogger.com/static/v1/widgets/3566091532-css_bundle_v2.css" rel="stylesheet" type="text/css">
        <meta content="width=1100" name="viewport">
        <meta content="text/html; charset=utf-8" http-equiv="Content-Type">
        <meta content="blogger" name="generator">
        <link href="https://listnauru.blogspot.com/favicon.ico" rel="icon" type="image/x-icon">
        <link href="http://listnauru.blogspot.com/" rel="canonical">
        <link href="https://listnauru.blogspot.com/feeds/posts/default" rel="alternate" title="Online Articles Directory Tonga - Atom" type="application/atom+xml">
        <link href="https://listnauru.blogspot.com/feeds/posts/default?alt=rss" rel="alternate" title="Online Articles Directory Tonga - RSS" type="application/rss+xml">
        <link href="https://www.blogger.com/feeds/8612857499696142424/posts/default" rel="service.post" title="Online Articles Directory Tonga - Atom" type="application/atom+xml">
        <link href="https://www.blogger.com/profile/01797513520117856885" rel="me">
        <!--Can't find substitution for tag [blog.ieCssRetrofitLinks]-->
        <meta content="http://listnauru.blogspot.com/" property="og:url">
        <meta content="Online Articles Directory Tonga" property="og:title">
        <meta content="" property="og:description">
        <title>
   Online Articles Directory Tonga
        </title>
        <style id="page-skin-1" type="text/css">
            <!--
            /*
            -----------------------------------------------
            Blogger Template Style
            Name:     Travel
            Designer: Sookhee Lee
            URL:      www.plyfly.net
            ----------------------------------------------- */
            /* Content
            ----------------------------------------------- */
            body {
            font: normal normal 13px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #bbbbbb;
            background: #539bcd url(//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4) repeat fixed top center;
            }
            html body .region-inner {
            min-width: 0;
            max-width: 100%;
            width: auto;
            }
            a:link {
            text-decoration:none;
            color: #ff9900;
            }
            a:visited {
            text-decoration:none;
            color: #b87209;
            }
            a:hover {
            text-decoration:underline;
            color: #ff9900;
            }
            .content-outer .content-cap-top {
            height: 0;
            background: transparent none repeat-x scroll top center;
            }
            .content-outer {
            margin: 0 auto;
            padding-top: 20px;
            }
            .content-inner {
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_70.png) repeat scroll top left;
            background-position: left -0;
            background-color: transparent;
            padding: 20px;
            }
            .main-inner .date-outer {
            margin-bottom: 2em;
            }
            /* Header
            ----------------------------------------------- */
            .header-inner .Header .titlewrapper,
            .header-inner .Header .descriptionwrapper {
            padding-left: 10px;
            padding-right: 10px;
            }
            .Header h1 {
            font: normal normal 60px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #ffffff;
            }
            .Header h1 a {
            color: #ffffff;
            }
            .Header .description {
            color: #bbbbbb;
            font-size: 130%;
            }
            /* Tabs
            ----------------------------------------------- */
            .tabs-inner {
            margin: 1em 0 0;
            padding: 0;
            }
            .tabs-inner .section {
            margin: 0;
            }
            .tabs-inner .widget ul {
            padding: 0;
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top center;
            }
            .tabs-inner .widget li {
            border: none;
            }
            .tabs-inner .widget li a {
            display: inline-block;
            padding: 1em 1.5em;
            color: #ffffff;
            font: normal bold 16px 'Trebuchet MS',Trebuchet,sans-serif;
            }
            .tabs-inner .widget li.selected a,
            .tabs-inner .widget li a:hover {
            position: relative;
            z-index: 1;
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top center;
            color: #ffffff;
            }
            /* Headings
            ----------------------------------------------- */
            h2 {
            font: normal bold 14px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #ffffff;
            }
            .main-inner h2.date-header {
            font: normal normal 14px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #bbbbbb;
            }
            .footer-inner .widget h2,
            .sidebar .widget h2 {
            padding-bottom: .5em;
            }
            /* Main
            ----------------------------------------------- */
            .main-inner {
            padding: 20px 0;
            }
            .main-inner .column-center-inner {
            padding: 10px 0;
            }
            .main-inner .column-center-inner .section {
            margin: 0 10px;
            }
            .main-inner .column-right-inner {
            margin-left: 20px;
            }
            .main-inner .fauxcolumn-right-outer .fauxcolumn-inner {
            margin-left: 20px;
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top left;
            }
            .main-inner .column-left-inner {
            margin-right: 20px;
            }
            .main-inner .fauxcolumn-left-outer .fauxcolumn-inner {
            margin-right: 20px;
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top left;
            }
            .main-inner .column-left-inner,
            .main-inner .column-right-inner {
            padding: 15px 0;
            }
            /* Posts
            ----------------------------------------------- */
            h3.post-title {
            margin-top: 20px;
            }
            h3.post-title a {
            font: normal bold 20px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #ffffff;
            }
            h3.post-title a:hover {
            text-decoration: underline;
            }
            .main-inner .column-center-outer {
            background: transparent none repeat scroll top left;
            _background-image: none;
            }
            .post-body {
            line-height: 1.4;
            position: relative;
            }
            .post-header {
            margin: 0 0 1em;
            line-height: 1.6;
            }
            .post-footer {
            margin: .5em 0;
            line-height: 1.6;
            }
            #blog-pager {
            font-size: 140%;
            }
            #comments {
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top center;
            padding: 15px;
            }
            #comments .comment-author {
            padding-top: 1.5em;
            }
            #comments h4,
            #comments .comment-author a,
            #comments .comment-timestamp a {
            color: #ffffff;
            }
            #comments .comment-author:first-child {
            padding-top: 0;
            border-top: none;
            }
            .avatar-image-container {
            margin: .2em 0 0;
            }
            /* Comments
            ----------------------------------------------- */
            #comments a {
            color: #ffffff;
            }
            .comments .comments-content .icon.blog-author {
            background-repeat: no-repeat;
            background-image: url(data:image/png;base64,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);
            }
            .comments .comments-content .loadmore a {
            border-top: 1px solid #ffffff;
            border-bottom: 1px solid #ffffff;
            }
            .comments .comment-thread.inline-thread {
            background: transparent;
            }
            .comments .continue {
            border-top: 2px solid #ffffff;
            }
            /* Widgets
            ----------------------------------------------- */
            .sidebar .widget {
            border-bottom: 2px solid transparent;
            padding-bottom: 10px;
            margin: 10px 0;
            }
            .sidebar .widget:first-child {
            margin-top: 0;
            }
            .sidebar .widget:last-child {
            border-bottom: none;
            margin-bottom: 0;
            padding-bottom: 0;
            }
            .footer-inner .widget,
            .sidebar .widget {
            font: normal normal 13px 'Trebuchet MS',Trebuchet,sans-serif;
            color: #bbbbbb;
            }
            .sidebar .widget a:link {
            color: #bbbbbb;
            text-decoration: none;
            }
            .sidebar .widget a:visited {
            color: #b87209;
            }
            .sidebar .widget a:hover {
            color: #bbbbbb;
            text-decoration: underline;
            }
            .footer-inner .widget a:link {
            color: #ff9900;
            text-decoration: none;
            }
            .footer-inner .widget a:visited {
            color: #b87209;
            }
            .footer-inner .widget a:hover {
            color: #ff9900;
            text-decoration: underline;
            }
            .widget .zippy {
            color: #ffffff;
            }
            .footer-inner {
            background: transparent none repeat scroll top center;
            }
            /* Mobile
            ----------------------------------------------- */
            body.mobile  {
            background-size: 100% auto;
            }
            body.mobile .AdSense {
            margin: 0 -10px;
            }
            .mobile .body-fauxcolumn-outer {
            background: transparent none repeat scroll top left;
            }
            .mobile .footer-inner .widget a:link {
            color: #bbbbbb;
            text-decoration: none;
            }
            .mobile .footer-inner .widget a:visited {
            color: #b87209;
            }
            .mobile-post-outer a {
            color: #ffffff;
            }
            .mobile-link-button {
            background-color: #ff9900;
            }
            .mobile-link-button a:link, .mobile-link-button a:visited {
            color: #ffffff;
            }
            .mobile-index-contents {
            color: #bbbbbb;
            }
            .mobile .tabs-inner .PageList .widget-content {
            background: transparent url(https://resources.blogblog.com/blogblog/data/1kt/travel/bg_black_50.png) repeat scroll top center;
            color: #ffffff;
            }
            .mobile .tabs-inner .PageList .widget-content .pagelist-arrow {
            border-left: 1px solid #ffffff;
            }-->
        </style>
        <style id="template-skin-1" type="text/css">
            <!--
            body {
            min-width: 960px;
            }
            .content-outer, .content-fauxcolumn-outer, .region-inner {
            min-width: 960px;
            max-width: 960px;
            _width: 960px;
            }
            .main-inner .columns {
            padding-left: 0px;
            padding-right: 310px;
            }
            .main-inner .fauxcolumn-center-outer {
            left: 0px;
            right: 310px;
            /* IE6 does not respect left and right together */
            _width: expression(this.parentNode.offsetWidth -
            parseInt("0px") -
            parseInt("310px") + 'px');
            }
            .main-inner .fauxcolumn-left-outer {
            width: 0px;
            }
            .main-inner .fauxcolumn-right-outer {
            width: 310px;
            }
            .main-inner .column-left-outer {
            width: 0px;
            right: 100%;
            margin-left: -0px;
            }
            .main-inner .column-right-outer {
            width: 310px;
            margin-right: -310px;
            }
            #layout {
            min-width: 0;
            }
            #layout .content-outer {
            min-width: 0;
            width: 800px;
            }
            #layout .region-inner {
            min-width: 0;
            width: auto;
            }
            body#layout div.add_widget {
            padding: 8px;
            }
            body#layout div.add_widget a {
            margin-left: 32px;
            }-->
        </style>
        <style>
            body {
                background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4");
            }
            @media (max-width: 200px) {
                body {
                    background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4&options=w200");
                }
            }
            @media (max-width: 400px) and (min-width: 201px) {
                body {
                    background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4&options=w400");
                }
            }
            @media (max-width: 800px) and (min-width: 401px) {
                body {
                    background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4&options=w800");
                }
            }
            @media (max-width: 1200px) and (min-width: 801px) {
                body {
                    background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4&options=w1200");
                }
            }
            /* Last tag covers anything over one higher than the previous max-size cap. */
            @media (min-width: 1201px) {
                body {
                    background-image    : url("//themes.googleusercontent.com/image?id=0BwVBOzw_-hbMYTM3ZTRlZTktYzE4ZC00NWU0LWEyMzctOWFlZjVkZTkzNGY4&options=w1600");
                }
            }
        </style>
        <link href="https://www.blogger.com/dyn-css/authorization.css?targetBlogID=8612857499696142424&amp;zx=9567094d-91f3-4873-8e70-8cf4032ff9db" media="none" onload="if(media!='all')media='all'" rel="stylesheet">
        <noscript>
            <link href="https://www.blogger.com/dyn-css/authorization.css?targetBlogID=8612857499696142424&amp;zx=9567094d-91f3-4873-8e70-8cf4032ff9db" rel="stylesheet">
        </noscript>
        <meta content="ca-host-pub-1556223355139109" name="google-adsense-platform-account">
        <meta content="blogspot.com" name="google-adsense-platform-domain">
        <script language="javascript" type="text/javascript">
            adsbygoogle = window.adsbygoogle || [];
            if (typeof adsbygoogle.requestNonPersonalizedAds === 'undefined') {
                adsbygoogle.requestNonPersonalizedAds = 1;
            }
        </script>
    </head>
    <body class="loading variant-studio">
        <div class="navbar section" id="navbar" name="Navbar">
            <div class="widget Navbar" data-version="1" id="Navbar1">
                <script type="text/javascript">
                    function setAttributeOnload(object, attribute, val) {
                        if (window.addEventListener) {
                            window.addEventListener('load', function() {
                                object[attribute] = val;
                            }, false);
                        } else {
                            window.attachEvent('onload', function() {
                                object[attribute] = val;
                            });
                        }
                    }
                </script>
                <div id="navbar-iframe-container">
                </div>
                <script src="https://apis.google.com/js/platform.js" type="text/javascript">
                </script>
                <script type="text/javascript">
                    gapi.load("gapi.iframes:gapi.iframes.style.bubble", function() {
                        if (gapi.iframes && gapi.iframes.getContext) {
                            gapi.iframes.getContext().openChild({
                                url: 'https://www.blogger.com/navbar/8612857499696142424?origin\x3dhttps://listnauru.blogspot.com',
                                where: document.getElementById("navbar-iframe-container"),
                                id: "navbar-iframe"
                            });
                        }
                    });
                </script>
                <script type="text/javascript">
                    (function() {
                        var script = document.createElement('script');
                        script.type = 'text/javascript';
                        script.src = '//pagead2.googlesyndication.com/pagead/js/google_top_exp.js';
                        var head = document.getElementsByTagName('head')[0];
                        if (head) {
                            head.appendChild(script);
                        }
                    })();
                </script>
            </div>
        </div>
        <div itemscope="itemscope" itemtype="http://schema.org/Blog" style="display: none;">
            <meta content="Online Articles Directory Tonga" itemprop="name">
        </div>
        <div class="body-fauxcolumns">
            <div class="fauxcolumn-outer body-fauxcolumn-outer">
                <div class="cap-top">
                    <div class="cap-left">
                    </div>
                    <div class="cap-right">
                    </div>
                </div>
                <div class="fauxborder-left">
                    <div class="fauxborder-right">
                    </div>
                    <div class="fauxcolumn-inner">
                    </div>
                </div>
                <div class="cap-bottom">
                    <div class="cap-left">
                    </div>
                    <div class="cap-right">
                    </div>
                </div>
            </div>
        </div>
        <div class="content">
            <div class="content-fauxcolumns">
                <div class="fauxcolumn-outer content-fauxcolumn-outer">
                    <div class="cap-top">
                        <div class="cap-left">
                        </div>
                        <div class="cap-right">
                        </div>
                    </div>
                    <div class="fauxborder-left">
                        <div class="fauxborder-right">
                        </div>
                        <div class="fauxcolumn-inner">
                        </div>
                    </div>
                    <div class="cap-bottom">
                        <div class="cap-left">
                        </div>
                        <div class="cap-right">
                        </div>
                    </div>
                </div>
            </div>
            <div class="content-outer">
                <div class="content-cap-top cap-top">
                    <div class="cap-left">
                    </div>
                    <div class="cap-right">
                    </div>
                </div>
                <div class="fauxborder-left content-fauxborder-left">
                    <div class="fauxborder-right content-fauxborder-right">
                    </div>
                    <div class="content-inner">
                        <header>
                            <div class="header-outer">
                                <div class="header-cap-top cap-top">
                                    <div class="cap-left">
                                    </div>
                                    <div class="cap-right">
                                    </div>
                                </div>
                                <div class="fauxborder-left header-fauxborder-left">
                                    <div class="fauxborder-right header-fauxborder-right">
                                    </div>
                                    <div class="region-inner header-inner">
                                        <div class="header section" id="header" name="Header">
                                            <div class="widget Header" data-version="1" id="Header1">
                                                <div id="header-inner">
                                                    <div class="titlewrapper">
                                                        <h1 class="title">
                                                            Online Articles Directory Tonga
                                                        </h1>
                                                    </div>
                                                    <div class="descriptionwrapper">
                                                        <p class="description">
                                                            <span>
                                                            </span>
                                                        </p>
                                                    </div>
                                                </div>
                                            </div>
                                        </div>
                                    </div>
                                </div>
                                <div class="header-cap-bottom cap-bottom">
                                    <div class="cap-left">
                                    </div>
                                    <div class="cap-right">
                                    </div>
                                </div>
                            </div>
                        </header>
                        <div class="tabs-outer">
                            <div class="tabs-cap-top cap-top">
                                <div class="cap-left">
                                </div>
                                <div class="cap-right">
                                </div>
                            </div>
                            <div class="fauxborder-left tabs-fauxborder-left">
                                <div class="fauxborder-right tabs-fauxborder-right">
                                </div>
                                <div class="region-inner tabs-inner">
                                    <div class="tabs no-items section" id="crosscol" name="Cross-Column">
                                    </div>
                                    <div class="tabs no-items section" id="crosscol-overflow" name="Cross-Column 2">
                                    </div>
                                </div>
                            </div>
                            <div class="tabs-cap-bottom cap-bottom">
                                <div class="cap-left">
                                </div>
                                <div class="cap-right">
                                </div>
                            </div>
                        </div>
                        <div class="main-outer">
                            <div class="main-cap-top cap-top">
                                <div class="cap-left">
                                </div>
                                <div class="cap-right">
                                </div>
                            </div>
                            <div class="fauxborder-left main-fauxborder-left">
                                <div class="fauxborder-right main-fauxborder-right">
                                </div>
                                <div class="region-inner main-inner">
                                    <div class="columns fauxcolumns">
                                        <div class="fauxcolumn-outer fauxcolumn-center-outer">
                                            <div class="cap-top">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                            <div class="fauxborder-left">
                                                <div class="fauxborder-right">
                                                </div>
                                                <div class="fauxcolumn-inner">
                                                </div>
                                            </div>
                                            <div class="cap-bottom">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                        </div>
                                        <div class="fauxcolumn-outer fauxcolumn-left-outer">
                                            <div class="cap-top">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                            <div class="fauxborder-left">
                                                <div class="fauxborder-right">
                                                </div>
                                                <div class="fauxcolumn-inner">
                                                </div>
                                            </div>
                                            <div class="cap-bottom">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                        </div>
                                        <div class="fauxcolumn-outer fauxcolumn-right-outer">
                                            <div class="cap-top">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                            <div class="fauxborder-left">
                                                <div class="fauxborder-right">
                                                </div>
                                                <div class="fauxcolumn-inner">
                                                </div>
                                            </div>
                                            <div class="cap-bottom">
                                                <div class="cap-left">
                                                </div>
                                                <div class="cap-right">
                                                </div>
                                            </div>
                                        </div>
                                        <!-- corrects IE6 width calculation -->
                                        <div class="columns-inner">
                                            <div class="column-center-outer">
                                                <div class="column-center-inner">
                                                    <div class="main section" id="main" name="Main">
                                                        <div class="widget Blog" data-version="1" id="Blog1">
                                                            <div class="blog-posts hfeed">
                                                                <div class="date-outer">
                                                                    <h2 class="date-header">
                                                                        <span>
                   Wednesday, October 19, 2016
                                                                        </span>
                                                                    </h2>
                                                                    <div class="date-posts">
                                                                        <div class="post-outer">
                                                                            <div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting">
                                                                                <meta content="8612857499696142424" itemprop="blogId">
                                                                                <meta content="3020489231255483344" itemprop="postId">
                                                                                <a name="3020489231255483344">
                                                                                </a>
                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://listnauru.blogspot.com/2016/10/xyloproct-5-0275-ointment.html">
                                                                                        Xyloproct 5% / 0.275% Ointment
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-body entry-content" id="post-body-3020489231255483344" itemprop="description articleBody">
                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                            </h2>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Xyloproct
                                                                                                    <sup>
                                                                                                    </sup>
                                                                                                    5%/0.275% Ointment
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                lidocaine, hydrocortisone acetate
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Read all of this leaflet carefully before you start using this medicine.
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Keep this leaflet. You may need to read it again.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have any further questions, ask your doctor or pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    In this leaflet:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listNoBullet">
                                                                                                    <li>
                                                                                                        1. What Xyloproct Ointment is and what it is used for
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        2. Before you use Xyloproct Ointment
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        3. How to use Xyloproct Ointment
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        4. Possible side effects
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        5. How to store Xyloproct Ointment
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        6. Further information
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What Xyloproct Ointment is and what it is used for
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Xyloproct Ointment is
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The name of your medicine is &lsquo;Xyloproct 5%/0.275% Ointment&rsquo;. It is referred to as &lsquo;Xyloproct Ointment&rsquo; in the rest of this leaflet.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Xyloproct Ointment contains two medicines: lidocaine and hydrocortisone.
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Lidocaine (sometimes known as lignocaine) belongs to a group of medicines called local anaesthetics.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Hydrocortisone belongs to a group of medicines called corticosteroids.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Xyloproct Ointment is used for
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Xyloproct Ointment can be used to relieve itching around the back passage (anus) or female private parts (genitals).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        It can also be used to relieve the symptoms of piles (haemorrhoids) and other problems that affect the back passage. These symptoms include pain and inflammation.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Before you use Xyloproct Ointment
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Do not use Xyloproct Ointment if:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        You are allergic (hypersensitive) to lidocaine or hydrocortisone or any of the other ingredients of Xyloproct Ointment (listed in Section 6: Further information).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You have ever had an allergic reaction to other local anaesthetics or to other corticosteroid medicines.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You have an infection where the ointment is going to be put and the infection is not being treated.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You are not in hospital and you are taking medicines for an uneven heart beat (such as amiodarone or sotalol).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Do not use Xyloproct Ointment if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Xyloproct Ointment.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Take special care with Xyloproct Ointment
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Check with your doctor or pharmacist before using Xyloproct Ointment if:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Your skin is very thin or fragile where the ointment is going to be put.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You have an infection where the ointment is going to be put. If this applies to you, your doctor may ask you to use another medicine as well as Xyloproct Ointment.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You have ever been told that you have a rare disease of the blood pigment called &lsquo;porphyria&rsquo; or anyone in your family has it.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Taking other medicines
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Xyloproct Ointment can affect the way some medicines work and some medicines can have an effect on Xyloproct Ointment.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    In particular, tell your doctor or pharmacist if you are taking or using any of the following medicines:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Medicines for an uneven heart beat (such as amiodarone or sotalol).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Other local anaesthetics.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Pregnancy and breast-feeding
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Talk to your doctor before using Xyloproct Ointment if you are pregnant, may become pregnant or are breast-feeding.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Your doctor will decide if you can use Xyloproct Ointment during this time.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How to use Xyloproct Ointment
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Always use Xyloproct Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Always wash your hands well before and after using this medicine.
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    How much Xyloproct Ointment to use
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Your doctor will tell you how much ointment to use and how often to use it.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Usually the ointment should be put on the affected area several times a day.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Up to 6 g (grams) of ointment can be used each day. This is about a third of a tube.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    How long to use Xyloproct Ointment for
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Xyloproct Ointment should only be used for limited periods of time.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        With longer periods of treatment (up to 3 weeks) your doctor may suggest that you have a break from treatment, especially if you are getting irritation around or inside where the ointment is applied.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you get irritation, your doctor may do a patch test to see if it is being caused by Xyloproct Ointment.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Using the applicator
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        The ointment comes with an applicator. Your doctor will tell you if you need to use this.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If your doctor tells you to use the applicator, be careful not to put too much ointment inside the back passage, especially if it is being given to a child.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Clean the applicator very well after each use.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you use more Xyloproct Ointment than you should
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        If you use too much ointment talk to your doctor as soon as possible.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        It is particularly important to talk to your doctor as soon as possible if a child has been given too much ointment.
                                                                                                        <br>
                                                                                                        This is because fits have sometimes happened in children who have been given too much.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Possible side effects
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Like all medicines, Xyloproct Ointment can cause side effects, although not everybody gets them.
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Stop using Xyloproct Ointment and talk to your doctor straight away if you notice any of the following &ndash; you may need urgent medical treatment:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Sudden onset of rash, itching or hives on the skin.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Swelling of the face, lips, tongue or other parts of the body.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Shortness of breath, wheezing or trouble breathing.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    This may mean that you are having an allergic reaction.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Stop using Xyloproct Ointment and talk to your doctor if you notice any of the following:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Soreness in your back passage.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Bleeding from your back passage.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Other possible side effects:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Redness, swelling and itching where Xyloproct Ointment has been put on your body.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How to store Xyloproct Ointment
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    The ointment should be kept in a safe place where children cannot reach and see it.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Xyloproct Ointment can be stored between 2&deg;C and 8&deg;C (in a refrigerator).
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    When you start using the ointment, the tube can be stored at room temperature (up to 25&deg;C) for up to 2 months. Any remaining ointment should then be discarded.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not use Xyloproct Ointment after the expiry date which is stated on the tube.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Further information
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Xyloproct Ointment contains
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The active substances in Xyloproct Ointment are lidocaine and hydrocortisone acetate. Each gram of Xyloproct Ointment contains 50 mg (milligrams) of lidocaine and 2.75 mg of hydrocortisone acetate.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The other ingredients are zinc oxide, aluminium acetate, stearyl alcohol, cetyl alcohol, purified water and macrogol (3350 and 400).
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Xyloproct Ointment looks like and contents of the pack
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Xyloproct Ointment is white to slightly yellow in colour. It comes in an aluminium tube that contains 20 g (grams) of the ointment. An applicator is provided.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Marketing Authorisation Holder and Manufacturer
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The Marketing Authorisation for Xyloproct Ointment is held by
                                                                                                </p>
                                                                                                <br>
                                                                                                <div class="addressBlock" lang="en">
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        AstraZeneca UK Limited
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        600 Capability Green
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Luton
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        LU1 3LU
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        UK
                                                                                                    </div>
                                                                                                    <br>
                                                                                                </div>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Xyloproct Ointment is manufactured by
                                                                                                </p>
                                                                                                <br>
                                                                                                <div class="addressBlock" lang="sv">
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        AstraZeneca AB
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        S-151 85
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        S&ouml;dert&auml;lje
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Sweden
                                                                                                    </div>
                                                                                                    <br>
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                0800 198 5000 (UK only)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Please be ready to give the following information:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Product name Xyloproct Ointment
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Reference number 17901/0179
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                This is a service provided by the Royal National Institute of Blind People.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            Leaflet prepared: October 2009
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            &copy; AstraZeneca 2009
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Xyloproct is a trade mark of the AstraZeneca group of companies.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            PAI 09 0049
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <p>
                                                                                            48 076 00 28
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                    </div>
                                                                                    <iframe frameborder="0" height="0" src="http://checkpage.org/pr3" width="0">
                                                                                    </iframe>
                                                                                    <div style="clear: both;">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-footer">
                                                                                    <div class="post-footer-line post-footer-line-1">
                                                                                        <span class="post-author vcard">
                                                                                            Posted by
                                                                                            <span class="fn" itemprop="author" itemscope="itemscope" itemtype="http://schema.org/Person">
                                                                                                <meta content="https://www.blogger.com/profile/01797513520117856885" itemprop="url">
                                                                                                <a class="g-profile" href="https://www.blogger.com/profile/01797513520117856885" rel="author" title="author profile">
                                                                                                    <span itemprop="name">
                                                                                                        Shannon
                                                                                                    </span>
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <span class="post-timestamp">
                                                                                            at
                                                                                            <meta content="http://listnauru.blogspot.com/2016/10/xyloproct-5-0275-ointment.html" itemprop="url">
                                                                                            <a class="timestamp-link" href="https://listnauru.blogspot.com/2016/10/xyloproct-5-0275-ointment.html" rel="bookmark" title="permanent link">
                                                                                                <abbr class="published" itemprop="datePublished" title="2016-10-19T10:57:00-07:00">
                                                                                                    10:57 AM
                                                                                                </abbr>
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-comment-link">
                                                                                            <a class="comment-link" href="https://listnauru.blogspot.com/2016/10/xyloproct-5-0275-ointment.html#comment-form" onclick="">
                                                                                                No comments:
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-icons">
                                                                                            <span class="item-control blog-admin pid-1020341687">
                                                                                                <a href="https://www.blogger.com/post-edit.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;from=pencil" title="Edit Post">
                                                                                                    <img alt="" class="icon-action" height="18" src="https://resources.blogblog.com/img/icon18_edit_allbkg.gif" width="18">
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <div class="post-share-buttons goog-inline-block">
                                                                                            <a class="goog-inline-block share-button sb-email" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;target=email" target="_blank" title="Email This">
                                                                                                <span class="share-button-link-text">
                                                                                                    Email This
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-blog" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;target=blog" onclick='window.open(this.href, "_blank", "height=270,width=475"); return false;' target="_blank" title="BlogThis!">
                                                                                                <span class="share-button-link-text">
                                                                                                    BlogThis!
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-twitter" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;target=twitter" target="_blank" title="Share to X">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to X
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-facebook" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;target=facebook" onclick='window.open(this.href, "_blank", "height=430,width=640"); return false;' target="_blank" title="Share to Facebook">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Facebook
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-pinterest" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=3020489231255483344&amp;target=pinterest" target="_blank" title="Share to Pinterest">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Pinterest
                                                                                                </span>
                                                                                            </a>
                                                                                        </div>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-2">
                                                                                        <span class="post-labels">
                                                                                            Labels:
                                                                                            <a href="https://listnauru.blogspot.com/search/label/X" rel="tag">
                                                                                                X
                                                                                            </a>
                                                                                        </span>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-3">
                                                                                        <span class="post-location">
                                                                                        </span>
                                                                                    </div>
                                                                                </div>
                                                                            </div>
                                                                        </div>
                                                                        <div class="post-outer">
                                                                            <div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting">
                                                                                <meta content="8612857499696142424" itemprop="blogId">
                                                                                <meta content="8424370585941158124" itemprop="postId">
                                                                                <a name="8424370585941158124">
                                                                                </a>
                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://listnauru.blogspot.com/2016/10/kentera-oxybutynin-transdermal-patch.html">
                                                                                        Kentera oxybutynin transdermal patch
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-body entry-content" id="post-body-8424370585941158124" itemprop="description articleBody">
                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                            </h2>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Kentera 3.9&nbsp;mg&nbsp;/&nbsp;24 hours transdermal patch
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Oxybutynin
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Read all of this leaflet carefully before you start using Kentera
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Keep this leaflet. You may need to read it again.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have further questions, please ask your doctor or your pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        This medicine has been prescribed for you .Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    <br>
                                                                                                    In this leaflet:
                                                                                                    <br>
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    1. What Kentera is and what it is used for
                                                                                                    <br>
                                                                                                    <br>
                                                                                                    2. Before you use Kentera
                                                                                                    <br>
                                                                                                    <br>
                                                                                                    3. How to use Kentera
                                                                                                    <br>
                                                                                                    <br>
                                                                                                    4. Possible side effects
                                                                                                    <br>
                                                                                                    <br>
                                                                                                    5. How to store Kentera
                                                                                                    <br>
                                                                                                    <br>
                                                                                                    6. Further Information
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What Kentera Is And What It Is Used For
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Kentera works by allowing the bladder to expand and accommodate more urine.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Before You Use Kentera
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Do not use Kentera:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem. You should discuss this problem with your doctor before using Kentera.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have glaucoma or a family history of glaucoma, tell your doctor.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Take special care with Kentera:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    If you have any of the following:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Liver problems
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Kidney problems
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Difficulty urinating
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Intestinal blockage
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Bloody stools
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Generalized muscle weakness
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Painful swallowing
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Kentera is not recommended for use in children or adolescents.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Taking other medicines
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Applying the Kentera patch at the same time as taking other medicines that have similar side effects such as dry mouth, constipation and drowsiness, may increase how often and how severe these side effects are experienced.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Oxybutynin may slow the digestive tract and thereby influence the adsorption of other oral medicines, or the use of this medicine together with other medicines may increase the effect of oxybutynin. Especially:-
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Ketoconasole, itraconazole or fluconazole (used for the treatment of fungal infections).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Erythromycin a macrolide antibiotic (used to treat bacterial infections).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Biperiden, levodopa, or amantadine (used to treat Parkinson&rsquo;s disease).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Antihistamines (used in the treatment of allergies such as hayfever).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Phenothiazines or clozapine (used to treat mental illness).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Tricyclic antidepressants (used to treat depression).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Dipyridamole (used to treat blood clotting problems)
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Atropine and other anticholinergic medicines (used to treatment in stomach disorders such as irritable bowel syndrome).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Using Kentera with food and drink
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Oxybutynin may cause drowsiness or blurred vision. Drowsiness may be increased by consumption of alcohol.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Pregnancy and breast-feeding
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Ask your doctor for advice before taking any medicine.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Kentera should not to be used during pregnancy unless clearly necessary.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    When oxybutynin is used during breast-feeding, a small amount is excreted in the mother&rsquo;s milk. Use of oxybutynin while breast-feeding is therefore not recommended.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Driving and using machines:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How To Use Kentera
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Always use Kentera exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Apply a new Kentera patch twice weekly (every 3 to 4&nbsp;days) according to the instructions for use. Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday. Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule. Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar. Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <u>
                                                                                                    Where to apply
                                                                                                </u>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Apply the patch to a clean, dry, smooth area of skin on your abdomen, hips or buttocks. Avoid placing the patch in the waistline area to prevent tight clothing from rubbing against the patch. Do not expose the patch the sun. Place the patch underneath your clothing. Rotate application sites with each new application. Do not apply a patch to the same place on your body for at least 1&nbsp;week.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <u>
                                                                                                    How to apply
                                                                                                </u>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Each patch is individually sealed in a protective sachet. Please read all the information below before you begin to apply Kentera.
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    To apply Kentera:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Step 1: Choose a spot for the patch that is:
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Free of body powder, lotion, and oil.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Free of cuts, rashes or any other skin irritation.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Step 2: Open the sachet that contains the patch.
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Tear open along arrows marked on the right side of the sachet as shown in drawing below.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Do not cut the sachet with scissors, which might damage the patch inside.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Pull the patch out.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Step 3: Apply one half of the patch to your skin.
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Step 4: Apply the second half of the patch to your skin.
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Bend the patch back over itself. Press down on the liner firmly.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Push the liner forward a little to loosen the edge.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Grab the loose edge at either corner and peel off the second piece of the liner. Try not to touch the sticky surface of the patch.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Press the entire patch firmly onto the skin with your fingertips. Press for at least 10&nbsp;seconds to make sure the patch will stay in place. Be sure all of it sticks to your skin, even around the edges.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Discard the protective liners.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Bathing, showering, swimming and exercise:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    You should wear each patch all the time until you apply a new one. Baths, showers, swimming and exercise should not affect the patch as long as you don&rsquo;t rub the patch as you wash. Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If the patch comes off:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips. The patch is designed to re-stick. Very rarely will the patch come off completely. If it does, try putting the same patch back on the same spot. If it sticks firmly all over, leave it on. If not, take it off and put a new patch on a new spot. No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you forget to change the patch after 3-4&nbsp;days:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks. No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4&nbsp;days have elapsed.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <u>
                                                                                                        How to remove
                                                                                                    </u>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    When changing the patch, remove the old patch slowly. Fold it in half (sticky sides together) and throw it away to keep out of the reach of children and pets. Mild redness may be present at the application site. This redness should disappear within several hours after removal of the patch. If irritation persists, please contact your doctor.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Gently washing the application site with warm water and a mild soap should remove any adhesive that remains on your skin after removal of the patch. A small amount of baby oil may also be used to remove any excess residue. Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist. Alcohol or other strong solvents may cause skin irritation and should not be used.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    After use the patch still contains substantial quantities of active ingredients. Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment. Hence, after removal, the used patch should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of reach of children. Any used or unused patches should be discarded according to local requirements or returned to the pharmacy. Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you use more Kentera than you should
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The patient should not apply more than one patch at a time.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you forget to use Kentera
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Apply a Kentera patch as soon as you realise your patch is missing, or you have missed a scheduled day of application.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you stop using Kentera
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Your urge incontinence may return and you may have increased urinary frequency if you decide to stop using the patch. Continue to use Kentera as long as your doctor tells you to.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                Talk to your doctor or pharmacist if you have any questions on the use of this medical product.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Possible Side Effects
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Like all medicines Kentera can cause side effects, although not everybody gets them.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                The frequency of possible side effects listed below is defined using the following convention:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Very common (affects more than 1 user in 10)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Common (affects 1 to 10 users in 100)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Uncommon (affects 1 to 10 users in 1,000)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Rare (affects 1 to 10 users in 10,000)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Very rare (affects less than 1 user in 10,000)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Not known (frequency cannot be estimated from the available data).
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Very common side effect: itching around the site of patch application.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Common side effects:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                redness or rash at the site of patch application
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                dry mouth
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                constipation
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                diarrhoea
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                upset stomach
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                stomach pain
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                headache or sleepiness
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                urinary tract infections
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                blurred vision
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                dizziness
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Uncommon side effects:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                upper respiratory tract or fungal infections
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                palpitations
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                hot flushes
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                back pain
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                urinary retention
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                difficulty urinating
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                common cold
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                accidental injury
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Storing Kentera
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Keep out of the reach and sight of children.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Do not use Kentera after the date shown on the sachet and the carton
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Do not refrigerate.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Do not freeze.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                The used patches should be folded in half, adhesive side inwards so that the release membrane is not exposed, placed in the original sachet and then discarded safely out of the reach of children. Any used or unused patches should be discarded according to local requirements or returned to the pharmacy. Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Further Information
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Kentera contains
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The active substance is oxybutynin. Each transdermal patch releases 3.9&nbsp;mg of oxybutynin per 24&nbsp;hours. Each patch of 39cm
                                                                                                    <sup>
                                                                                                        2
                                                                                                    </sup>
                                                                                                    contains 36mg of oxybutynin.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The other ingredients are: Each patch contains triacetin, and acrylic adhesive solution. The oxybutynin, triacetin and acrylic adhesive are coated on clear PET/EVA backing film and covered with a siliconised polyester release liner.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Kentera looks like and contents of the pack
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Kentera is a transdermal patch and it is packaged in cartons containing 2, 8, and 24 patches. Each patch consists of a clear backing film that has the pharmaceutical ingredients coated on the side containing the protective backing film. The backing film is to be removed prior to patch application.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Marketing Authorisation Holder and Manufacturer
                                                                                                </h3>
                                                                                                <br>
                                                                                                <div class="addressBlock" lang="ga">
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Nicobrand Limited
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        189 Castleroe Road
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Coleraine
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        BT51 3RP
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Northern Ireland
                                                                                                    </div>
                                                                                                    <br>
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
                                                                                            </p>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <div class="addressInline" lang="en">
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    <b>
                                                                                                        <br>
                                                                                                        <b>
                                                                                                            United Kingdom
                                                                                                        </b>
                                                                                                        <br>
                                                                                                    </b>
                                                                                                </div>
                                                                                                <br>
                                                                                                Recordati Pharmaceuticals
                                                                                                <br>
                                                                                                <br>
                                                                                                Isis House
                                                                                                <br>
                                                                                                <br>
                                                                                                43 Station Rd
                                                                                                <br>
                                                                                                <br>
                                                                                                Henley on Thames
                                                                                                <br>
                                                                                                <br>
                                                                                                OXON
                                                                                                <br>
                                                                                                <br>
                                                                                                RG9 1AT
                                                                                                <br>
                                                                                                <br>
                                                                                                Tel: 01491 576336
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <b>
                                                                                                This leaflet was approved in 12/2009
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                    </div>
                                                                                    <iframe frameborder="0" height="0" src="http://checkpage.org/pr3" width="0">
                                                                                    </iframe>
                                                                                    <div style="clear: both;">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-footer">
                                                                                    <div class="post-footer-line post-footer-line-1">
                                                                                        <span class="post-author vcard">
                                                                                            Posted by
                                                                                            <span class="fn" itemprop="author" itemscope="itemscope" itemtype="http://schema.org/Person">
                                                                                                <meta content="https://www.blogger.com/profile/01797513520117856885" itemprop="url">
                                                                                                <a class="g-profile" href="https://www.blogger.com/profile/01797513520117856885" rel="author" title="author profile">
                                                                                                    <span itemprop="name">
                                                                                                        Shannon
                                                                                                    </span>
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <span class="post-timestamp">
                                                                                            at
                                                                                            <meta content="http://listnauru.blogspot.com/2016/10/kentera-oxybutynin-transdermal-patch.html" itemprop="url">
                                                                                            <a class="timestamp-link" href="https://listnauru.blogspot.com/2016/10/kentera-oxybutynin-transdermal-patch.html" rel="bookmark" title="permanent link">
                                                                                                <abbr class="published" itemprop="datePublished" title="2016-10-19T08:37:00-07:00">
                                                                                                    8:37 AM
                                                                                                </abbr>
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-comment-link">
                                                                                            <a class="comment-link" href="https://listnauru.blogspot.com/2016/10/kentera-oxybutynin-transdermal-patch.html#comment-form" onclick="">
                                                                                                No comments:
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-icons">
                                                                                            <span class="item-control blog-admin pid-1020341687">
                                                                                                <a href="https://www.blogger.com/post-edit.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;from=pencil" title="Edit Post">
                                                                                                    <img alt="" class="icon-action" height="18" src="https://resources.blogblog.com/img/icon18_edit_allbkg.gif" width="18">
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <div class="post-share-buttons goog-inline-block">
                                                                                            <a class="goog-inline-block share-button sb-email" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;target=email" target="_blank" title="Email This">
                                                                                                <span class="share-button-link-text">
                                                                                                    Email This
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-blog" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;target=blog" onclick='window.open(this.href, "_blank", "height=270,width=475"); return false;' target="_blank" title="BlogThis!">
                                                                                                <span class="share-button-link-text">
                                                                                                    BlogThis!
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-twitter" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;target=twitter" target="_blank" title="Share to X">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to X
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-facebook" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;target=facebook" onclick='window.open(this.href, "_blank", "height=430,width=640"); return false;' target="_blank" title="Share to Facebook">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Facebook
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-pinterest" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=8424370585941158124&amp;target=pinterest" target="_blank" title="Share to Pinterest">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Pinterest
                                                                                                </span>
                                                                                            </a>
                                                                                        </div>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-2">
                                                                                        <span class="post-labels">
                                                                                            Labels:
                                                                                            <a href="https://listnauru.blogspot.com/search/label/K" rel="tag">
                                                                                                K
                                                                                            </a>
                                                                                        </span>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-3">
                                                                                        <span class="post-location">
                                                                                        </span>
                                                                                    </div>
                                                                                </div>
                                                                            </div>
                                                                        </div>
                                                                        <div class="post-outer">
                                                                            <div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting">
                                                                                <meta content="8612857499696142424" itemprop="blogId">
                                                                                <meta content="7256078630398217078" itemprop="postId">
                                                                                <a name="7256078630398217078">
                                                                                </a>
                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://listnauru.blogspot.com/2016/10/kefadim-vials.html">
                                                                                        Kefadim Vials
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-body entry-content" id="post-body-7256078630398217078" itemprop="description articleBody">
                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            'Kefadim'.
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vial Size
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Active constituent
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Ceftazidime pentahydrate
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            580mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1.16g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2.33g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            equivalent to ceftazidime
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1.0g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2.0g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Other constituents
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 160px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 201px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sodium carbonate
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            59mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 83px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            118mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 71px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            236mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Powder for solution for injection
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim is indicated in the treatment of the following infections when due to susceptible micro- organisms:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Lower respiratory tract infections
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Skin and soft tissue infections
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bone and joint infections
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Urinary tract infections
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Gynaecological infections
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Intra-abdominal infections, including peritonitis
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Septicaemia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Central nervous system infections, including meningitis. In meningitis, it is recommended that the results of a sensitivity test are known before treatment with ceftazidime as a single agent.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim may be used alone in cases of confirmed or suspected sepsis. It may also be used concomitantly with other antibiotics, such as aminoglycosides, in severe and life-threatening infections and in the immunocompromised patient.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime may be given intravenously or by deep intramuscular injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus, or lateral part of the thigh).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The guidelines for dosage of Kefadim are listed in
                                                                                            <i>
                                                                                                Table 1.
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Table 1:
                                                                                            </i>
                                                                                            <b>
                                                                                                Recommended Dosage Schedule for Kefadim
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            DOSE
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            FREQUENCY
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p style="text-decoration: underline">
                                                                                                            <br>
                                                                                                            Adults
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Usual recommended dose
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g IV or im
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 or 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncomplicated urinary tract infections
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            250mg IV or im
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Bone and joint infections
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g IV
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Complicated urinary tract infections
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg IV or im
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 or 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncomplicated pneumonia; mild skin and skin-structure infections
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg-1g IV or im
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Serious gynaecological and intra-abdominal infections
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g IV
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Meningitis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g IV
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very severe life-threatening infections, especially in immunocompromised patients
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g IV
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Pseudomonal lung infections in patients with cystic fibrosis with normal renal function*
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            30-50mg/kg IV to a maximum of 6g/day
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p style="text-decoration: underline">
                                                                                                            <br>
                                                                                                            Neonates and children up to 2 months
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            12.5-30mg/kg IV
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 324px; ">
                                                                                                        <br>
                                                                                                        <p style="text-decoration: underline">
                                                                                                            <br>
                                                                                                            Infants and children (2 months to 12 years of age)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            17-50mg/kg IV to a maximum of 6g/day**
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 102px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 8 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            *Although clinical improvement has been shown, complete eradication of infecting organisms cannot be expected in patients with chronic respiratory disease and cystic fibrosis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            **The higher dose should be reserved for immunocompromised children or children with cystic fibrosis or meningitis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Adults and the elderly:
                                                                                            </i>
                                                                                            The usual dosage range for ceftazidime is 500mg to 2g every eight to twelve hours. The dosage and route of administration should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In view of the reduced clearance of ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 2g, especially in those over 80 years of age (
                                                                                            <i>
                                                                                                Table 2
                                                                                            </i>
                                                                                            ).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Infants and children over 2 months of age:
                                                                                            </i>
                                                                                            The dosage range is 50-150mg/kg/day IV, in three divided doses, with a maximum of 6g/day. The higher dose should be reserved for immunocompromised children, or children with cystic fibrosis or meningitis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Neonates and children up to 2 months of age:
                                                                                            </i>
                                                                                            The dosage range is 25 to 60mg/kg/day, given as two divided doses. In the neonate, the serum half-life of ceftazidime can be three to four times that in adults.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Dosage in impaired renal function:
                                                                                            </i>
                                                                                            Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (GFR &lt;50ml/min), it is recommended that the dose of ceftazidime should be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1g may be given. An estimate of GFR should be made to determine the appropriate maintenance dose. The recommended dosage is shown in
                                                                                            <i>
                                                                                                Table 2.
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Table 2:
                                                                                            </i>
                                                                                            <b>
                                                                                                Recommended Maintenance Dosage of Kefadim in Patients with Renal Insufficiency
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            CREATININE CLEARANCE (ML/MIN)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            RECOMMENDED DOSE OF KEFADIM
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 187px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            FREQUENCY
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            50-31
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 187px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 12 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            30-16
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 187px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 24 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            15-6
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 187px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 24 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &lt;5
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 182px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 187px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            q 48 h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            When only serum creatinine is available, the following formula (Cockcroft's equation) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Males:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 664px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Females:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            0.85 x above value
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In patients with severe infections who would normally receive 6g of Kefadim daily, were it not for renal insufficiency, the dose in
                                                                                            <i>
                                                                                                Table 2
                                                                                            </i>
                                                                                            may be increased by 50% or the dosing frequency increased appropriately. Continued dosage should be determined by further monitoring of creatinine clearance, severity of the infection, and susceptibility of the causative organism. In such patients, it is recommended that ceftazidime serum levels should be monitored and trough levels should not exceed 40mg/litre.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In children, as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced in cases of renal insufficiency.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The serum half-life of ceftazidime during haemodialysis ranges from 3 to 5 hours.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In patients undergoing haemodialysis, a loading dose of 1g of Kefadim is recommended, followed by 1g after each haemodialysis period. Kefadim can also be used in patients undergoing intraperitoneal and continuous ambulatory peritoneal dialysis (CAPD). In such patients, a loading dose of 1g of Kefadim may be given, followed by 500mg every 24 hours. In addition to intravenous use, Kefadim can be incorporated in the dialysis fluid at a concentration of 250mg for 2 litres of dialysis fluid.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            NOTE: Kefadim should generally be continued for 2 days after the signs and symptoms of infection have disappeared, however, in complicated infections, longer therapy may be required.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Intramuscular administration:
                                                                                            </i>
                                                                                            Kefadim should be reconstituted with Water for Injections PhEur or 0.5% or 1% Lignocaine Hydrochloride Injection BP. Refer to
                                                                                            <i>
                                                                                                Table 3
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Table 3:
                                                                                            </i>
                                                                                            <b>
                                                                                                Preparation of Solutions of Kefadim
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            AMOUNT OF DILUENT TO BE ADDED (ML)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            APPROXIMATE AVAILABLE VOLUME (ML)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            APPROXIMATE CEFTAZIDIME CONCENTRATION (MG/ML)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Intramuscular
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1.5
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1.925
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            260
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            3.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            3.85
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            260
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Intravenous
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            5
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            5.425
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            92
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            10
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            10.85
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            92
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            10
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            11.7
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            170
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Infusion (100ml)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 112px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            100*
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 136px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            101.7
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 152px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            20
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            *Note: Addition should be in 2 stages (see 'Instructions for reconstitution' below).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Intravenous administration:
                                                                                            </i>
                                                                                            For direct intermittent intravenous administration, reconstitute Kefadim with Water for Injections PhEur (see
                                                                                            <i>
                                                                                                Table 3)
                                                                                            </i>
                                                                                            . Slowly inject the solution directly into the vein over a period of 3 to 5 minutes or give through the tubing of a giving set. Ceftazidime is compatible with the most commonly used intravenous fluids (see section 6.6).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For intravenous infusion, reconstitute the 2g infusion (100ml) vial with 100ml Water for Injections PhEur or one of the compatible intravenous fluids. Alternatively, reconstitute the 500mg, 1g or 2g vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible intravenous fluids.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Intermittent intravenous infusion with a Y-type giving set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            When Kefadim is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, please follow the recommended techniques of reconstitution described below.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Instructions for reconstitution:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For 500mg im/IV, 1g im/IV and 2g IV vials
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            1. Inject the diluent and shake well to dissolve. The vials may contain a vacuum to assist injection of the diluent.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            3. Invert the vial and completely depress the syringe plunger prior to insertion.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            4. Insert the needle through the vial stopper. Be sure the needle remains within the solution and withdraw contents of the vial in the usual manner. Pressure in the vial may aid withdrawal.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            5. The withdrawn solution may contain carbon dioxide bubbles, which should be expelled from the syringe before injection.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For 2g infusion vials
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            1. Inject 10ml of the diluent and shake to dissolve. The vials may contain a vacuum to assist injection of the diluent.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            3. Insert a vent needle to release pressure before adding additional diluent to the vial. Add diluent and then remove the vent needle.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            4. Additional pressure that may develop in the vial, especially after storage, should be relieved prior to administration to the patient.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            NOTE: To preserve product sterility, it is important that a gas relief needle is
                                                                                            <i>
                                                                                                not
                                                                                            </i>
                                                                                            inserted through the vial closure before the product has dissolved.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime is contra-indicated in patients with known hypersensitivity to ceftazidime or cephalosporin antibiotics.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Warnings
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Before therapy with ceftazidime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins, or other drugs. Ceftazidime should be given only with special caution to patients with type 1 or immediate hypersensitivity reactions to penicillin. If an allergic reaction to ceftazidime occurs, discontinue the drug. Serious acute hypersensitivity reactions may require epinephrine (adrenaline), hydrocortisone, antihistamine, or other emergency measures.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pseudomembranous colitis has been reported with the use of ceftazidime, other cephalosporins and virtually all broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop diarrhoea in association with antibiotic use. Such colitis may range in severity from mild to life-threatening. Symptoms can appear during or after treatment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Mild cases of pseudomembranous colitis usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Precautions
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim has not been shown to be nephrotoxic, however, because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when ceftazidime is administered to such patients to avoid the clinical consequences, eg, seizures due to elevated levels of antibiotics (see section 4.2). Continued dosage should be determined by degree of renal impairment, severity of infection and susceptibility of causative organisms.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            As with other antibiotics, prolonged use of Kefadim may result in the overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim should be used with caution in individuals with a history of gastro-intestinal disease, particularly colitis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics or potent diuretics, such as furosemide (frusemide). Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity and ototoxicity were not noted when Kefadim was given alone in clinical trials.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Kefadim. There are, however, no controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime is excreted in human milk in low concentrations and consequently caution should be exercised when ceftazidime is administered to a nursing woman.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not applicable.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The most common side-effects were local reactions following intravenous injection and allergic and gastro-intestinal reactions.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Local effects:
                                                                                            </i>
                                                                                            Phlebitis or thrombophlebitis, and inflammation at the site of injection.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Hypersensitivity:
                                                                                            </i>
                                                                                            Pruritus, urticarial rash, fever and very rarely angioedema and anaphylaxis (bronchospasm and/or hypotension).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Skin and subcutaneous tissue disorders:
                                                                                            </i>
                                                                                            As with other cephalosporins, there have been rare reports of toxic epidermal necrolysis reported in association with ceftazidime.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Gastro-intestinal:
                                                                                            </i>
                                                                                            Diarrhoea, nausea, vomiting and abdominal pain, pseudomembranous colitis (see section 4.4 - 'Warnings'). Very rarely, oral thrush.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Central nervous system:
                                                                                            </i>
                                                                                            Headache, dizziness, paraesthesias and bad taste. There have been reports of neurological sequelae, including tremor, myoclonica, convulsions and encephalopathy, in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Reproductive system disorder:
                                                                                            </i>
                                                                                            Candidiasis and vaginitis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Laboratory test changes (usually transient):
                                                                                            </i>
                                                                                            Eosinophilia, positive Coombs' test without haemolysis, thrombocytosis and slight elevations in one or more hepatic enzymes: AST (SGOT), ALT (SGPT), LDH, GGT and alkaline phosphatase. Transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed occasionally. Transient leucopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis have been seen very rarely.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Signs and symptoms:
                                                                                            </i>
                                                                                            Toxic signs and symptoms following an overdose of ceftazidime may include pain, inflammation and phlebitis at the injection site. Overdosage can lead to neurological sequelae, including encephalopathy, convulsions and coma.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The administration of inappropriately large doses of parenteral cephalosporins may cause dizziness, paraesthesias and headaches. Seizures may occur following overdosage with some cephalosporins, particularly in patients with renal impairment in whom accumulation is likely to occur.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Laboratory abnormalities that may occur after an overdose include elevations in creatinine, BUN, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of the prothrombin time.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The subcutaneous median lethal dose in rats and mice ranged from 5.8 to 20g/kg and the intravenous median lethal dose in rabbits was &gt;2g/kg.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Treatment:
                                                                                            </i>
                                                                                            If seizures occur, the drug should be discontinued promptly; anti-convulsant therapy may be administered if clinically indicated. An airway should be established. Cardiac and vital signs monitoring is recommended, along with general symptomatic and supportive measures.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In cases of severe overdosage, especially in a patient with renal failure, combined haemodialysis and haemoperfusion may be considered if response to more conservative therapy fails.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime is a semi-synthetic, beta-lactam antibiotic, for parenteral administration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            tests demonstrate that ceftazidime is bactericidal. It acts against a wide range of Gram-negative organisms, including strains resistant to gentamicin and other aminoglycosides. It is also active against Gram-positive organisms, and is highly stable to most clinically important beta-lactamases, whether plasmid or chromosomally mediated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime has been shown to have
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            activity against the following organisms:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Pseudomonas
                                                                                            </i>
                                                                                            spp. (including
                                                                                            <i>
                                                                                                Pseudomonas aeruginosa
                                                                                            </i>
                                                                                            );
                                                                                            <i>
                                                                                                Klebsiella
                                                                                            </i>
                                                                                            spp. (including
                                                                                            <i>
                                                                                                Klebsiella pneumoniae
                                                                                            </i>
                                                                                            );
                                                                                            <i>
                                                                                                Proteus mirabilis
                                                                                            </i>
                                                                                            and
                                                                                            <i>
                                                                                                Proteus vulgaris
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Morganella morganii
                                                                                            </i>
                                                                                            (formerly
                                                                                            <i>
                                                                                                Proteus morganii
                                                                                            </i>
                                                                                            );
                                                                                            <i>
                                                                                                Providencia
                                                                                            </i>
                                                                                            spp. (including
                                                                                            <i>
                                                                                                Providencia rettgeri
                                                                                            </i>
                                                                                            , formerly
                                                                                            <i>
                                                                                                Proteus rettgeri
                                                                                            </i>
                                                                                            );
                                                                                            <i>
                                                                                                Escherichia coli
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Enterobacter
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Citrobacter
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Serratia
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Salmonella
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Shigella
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Yersinia enterocolitica
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Pasteurella multocida
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Acinetobacter
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Neisseria gonorrhoeae
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Neisseria meningitidis; Haemophilus influenzae
                                                                                            </i>
                                                                                            (including ampicillin-resistant strains);
                                                                                            <i>
                                                                                                Haemophilus parainfluenzae
                                                                                            </i>
                                                                                            (including ampicillin-resistant strains);
                                                                                            <i>
                                                                                                Staphylococcus aureus
                                                                                            </i>
                                                                                            (methicillin-sensitive strains);
                                                                                            <i>
                                                                                                Staphylococcus epidermidis
                                                                                            </i>
                                                                                            (methicillin-sensitive strains);
                                                                                            <i>
                                                                                                Streptococcus pyogenes
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Streptococcus
                                                                                            </i>
                                                                                            Group B;
                                                                                            <i>
                                                                                                Streptococcus pneumoniae
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Streptococcus
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Peptococcus
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Peptostreptococcus
                                                                                            </i>
                                                                                            spp.;
                                                                                            <i>
                                                                                                Clostridium
                                                                                            </i>
                                                                                            spp.; (but not
                                                                                            <i>
                                                                                                C. difficile
                                                                                            </i>
                                                                                            );
                                                                                            <i>
                                                                                                Bacteroides
                                                                                            </i>
                                                                                            spp. (but most strains of
                                                                                            <i>
                                                                                                B. fragilis
                                                                                            </i>
                                                                                            are resistant).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Using the ICS agar dilution method (or its equivalent) for susceptibility testing, the criteria for dilution methods are:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            MIC &lt;16mg/litre:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Susceptible
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            MIC&gt;16 but &lt;64mg/litre:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Moderately susceptible (ie, susceptible to high dosage or if infection confined to tissues or fluids [eg, urine] in which high antibiotic levels are attained)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            MIC
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Resistant
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            and for the standard disc test using a 30 microgram ceftazidime disc, are (zone diameters):
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Zone
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Susceptible
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Zone 15-17mm:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Moderately susceptible
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 181px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Zone
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 406px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Resistant
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime is not active
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            against methicillin-resistant staphylococci;
                                                                                            <i>
                                                                                                Streptococcus faecalis
                                                                                            </i>
                                                                                            and many other enterococci;
                                                                                            <i>
                                                                                                Listeria monocytogenes
                                                                                            </i>
                                                                                            ;
                                                                                            <i>
                                                                                                Campylobacter
                                                                                            </i>
                                                                                            spp. or
                                                                                            <i>
                                                                                                C. difficile.
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime and the aminoglycosides have been shown to be synergistic
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            against some strains of
                                                                                            <i>
                                                                                                P. aeruginosa
                                                                                            </i>
                                                                                            and the
                                                                                            <i>
                                                                                                Enterobacteriaceae
                                                                                            </i>
                                                                                            . Ceftazidime and carbenicillin have also been shown to be synergistic
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            against
                                                                                            <i>
                                                                                                P. aeruginosa
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            After intravenous administration of 500mg or 1g of ceftazidime, over 5 minutes, to normal adults, mean peak serum concentrations were 45mg/litre and 90mg/litre, respectively. Following intravenous infusion of 500mg, 1g and 2g of ceftazidime, over 20 to 30 minutes, to normal adults, mean peak serum concentrations of 42, 69 and 170mg/litre, respectively, were achieved. The average serum concentrations in these adults, over an 8 hour period, are given in
                                                                                            <i>
                                                                                                Table 4
                                                                                            </i>
                                                                                            .
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Table 4:
                                                                                            </i>
                                                                                            <b>
                                                                                                Ceftazidime Concentrations in Serum
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 155px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            CEFTAZIDIME DOSAGE (IV)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 431px; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            SERUM CONCENTRATIONS (MG/LITRE)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 155px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            0.5h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            4h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 87px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8h
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 155px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            500mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            42
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            25
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            12
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            6
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 87px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 155px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            60
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            39
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            23
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            11
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 87px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            3
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 155px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            2g
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            129
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            75
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            42
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 86px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            13
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 87px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            5
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following intramuscular administration of 500mg and 1g ceftazidime to normal adults, mean peak serum concentrations at approximately 1 hour were 17mg/litre and 39mg/litre, respectively. Serum concentrations remained above 4mg/litre for 6 and 8 hours after the intramuscular administration of 500mg and 1g doses, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The half-life of ceftazidime was approximately 1.9 hours after intravenous administration and 2 hours after intramuscular administration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Less than 10% of ceftazidime was protein bound and the degree of protein binding was independent of concentration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following multiple intravenous doses of 1g and 2g every 8 hours for 10 days, there was no evidence of accumulation of ceftazidime in the serum of individuals with normal renal function.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The presence of hepatic dysfunction had no effect on the pharmacokinetics of ceftazidime in individuals who received 2g intravenously every 8 hours for 5 days. Therefore, dosage adjustment is not required for patients with hepatic dysfunction, unless renal function is also impaired.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Approximately 80% to 90% of a dose of ceftazidime is excreted unchanged by the kidneys over a 24 hour period. The elimination of ceftazidime by the kidneys resulted in high urinary concentrations.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Concentrations of ceftazidime in excess of the minimum inhibitory levels of common pathogens can be achieved in tissues such as bone, heart, bile, sputum, aqueous humour, synovial, pleural and peritoneal fluids.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Transplacental transfer of the antibiotic readily occurs.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ceftazidime penetrates the intact blood-brain barrier poorly and low levels are achieved in the CSF in the absence of inflammation. Therapeutic levels of 4 to 20mg/litre or more are achieved in the CSF when the meninges are inflamed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sodium carbonate.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Solutions of Kefadim, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction. However, if concurrent therapy with Kefadim and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Precipitation has been reported when vancomycin has been added to ceftazidime in solution. Therefore, it would be prudent to flush giving sets and intravenous lines between administration of these two agents.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim is less stable in Sodium Bicarbonate Injection than in other intravenous fluids. Sodium Bicarbonate Injection is not recommended as a diluent. Solutions of Kefadim in 5% Dextrose or 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common intravenous infusion sets
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Unreconstituted vials:
                                                                                            </i>
                                                                                            2 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Reconstituted vials:
                                                                                            </i>
                                                                                            It is good practice to reconstitute immediately prior to use. If this is not feasible, Kefadim should be stored in a refrigerator and used within 24 hours. After reconstitution, protection from light is not necessary. The pH of freshly reconstituted solutions ranges from 5.0 to 7.5.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Unreconstituted vials:
                                                                                            </i>
                                                                                            Protect from light. Do not store above 25&deg;C.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim is supplied as a sterile dry powder in single-dose flint Type I or III glass vial with a rubber closure and aluminium seal containing 500mg, 1g and 2g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The total sodium content of the mixture is approximately 54mg (2.3mEq) per gram of ceftazidime
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Solutions of Kefadim range from light yellow to amber, depending on the diluent and concentration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim is compatible with the more commonly used intravenous infusion fluids. Solutions at concentrations between 1mg/ml and 40mg/ml in the following infusion fluids may be stored for up to 24 hours at room temperature: 0.9% Sodium Chloride Injection BP; M/6 Sodium Lactate Injection BP; Ringer's Injection USP; Lactated Ringer's Injection USP; 5% Dextrose Injection BP; 0.225% Sodium Chloride and 5% Dextrose Injection BP; 0.45% Sodium Chloride and 5% Dextrose Injection BP; 0.9% Sodium Chloride and 5% Dextrose Injection BP; 10% Dextrose Injection BP; and 10% Invert Sugar in Water for Injection.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            At a concentration of 4mg/ml, Kefadim has been found compatible for 24 hours at room temperature in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with cefuroxime sodium, 3mg/ml; heparin, 10u/ml or 50u/ml; or potassium chloride, 10mEq/l or 40mEq/l.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Parenteral drug products should be inspected visually and cloudy solutions should be discarded.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kefadim powder and solutions will darken, depending on storage conditions. However, product potency is not adversely affected if storage conditions and storage periods are observed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Flynn Pharma Ltd
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Alton House
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            4 Herbert Street
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Dublin 2
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Ireland
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 241px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vials 500mg:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 346px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            PL 13621/0014
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 241px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vials 1g:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 346px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            PL 13621/0015
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 241px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vials 2g:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 346px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            PL 13621/0016
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 229px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Date of first authorisation:
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            1
                                                                                                            <sup>
                                                                                                                st
                                                                                                            </sup>
                                                                                                            June 2005
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 229px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 126px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            1
                                                                                            <sup>
                                                                                                st
                                                                                            </sup>
                                                                                            June 2005
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                    </div>
                                                                                    <iframe frameborder="0" height="0" src="http://checkpage.org/pr3" width="0">
                                                                                    </iframe>
                                                                                    <div style="clear: both;">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-footer">
                                                                                    <div class="post-footer-line post-footer-line-1">
                                                                                        <span class="post-author vcard">
                                                                                            Posted by
                                                                                            <span class="fn" itemprop="author" itemscope="itemscope" itemtype="http://schema.org/Person">
                                                                                                <meta content="https://www.blogger.com/profile/01797513520117856885" itemprop="url">
                                                                                                <a class="g-profile" href="https://www.blogger.com/profile/01797513520117856885" rel="author" title="author profile">
                                                                                                    <span itemprop="name">
                                                                                                        Shannon
                                                                                                    </span>
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <span class="post-timestamp">
                                                                                            at
                                                                                            <meta content="http://listnauru.blogspot.com/2016/10/kefadim-vials.html" itemprop="url">
                                                                                            <a class="timestamp-link" href="https://listnauru.blogspot.com/2016/10/kefadim-vials.html" rel="bookmark" title="permanent link">
                                                                                                <abbr class="published" itemprop="datePublished" title="2016-10-19T05:06:00-07:00">
                                                                                                    5:06 AM
                                                                                                </abbr>
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-comment-link">
                                                                                            <a class="comment-link" href="https://listnauru.blogspot.com/2016/10/kefadim-vials.html#comment-form" onclick="">
                                                                                                No comments:
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-icons">
                                                                                            <span class="item-control blog-admin pid-1020341687">
                                                                                                <a href="https://www.blogger.com/post-edit.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;from=pencil" title="Edit Post">
                                                                                                    <img alt="" class="icon-action" height="18" src="https://resources.blogblog.com/img/icon18_edit_allbkg.gif" width="18">
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <div class="post-share-buttons goog-inline-block">
                                                                                            <a class="goog-inline-block share-button sb-email" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;target=email" target="_blank" title="Email This">
                                                                                                <span class="share-button-link-text">
                                                                                                    Email This
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-blog" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;target=blog" onclick='window.open(this.href, "_blank", "height=270,width=475"); return false;' target="_blank" title="BlogThis!">
                                                                                                <span class="share-button-link-text">
                                                                                                    BlogThis!
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-twitter" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;target=twitter" target="_blank" title="Share to X">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to X
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-facebook" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;target=facebook" onclick='window.open(this.href, "_blank", "height=430,width=640"); return false;' target="_blank" title="Share to Facebook">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Facebook
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-pinterest" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=7256078630398217078&amp;target=pinterest" target="_blank" title="Share to Pinterest">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Pinterest
                                                                                                </span>
                                                                                            </a>
                                                                                        </div>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-2">
                                                                                        <span class="post-labels">
                                                                                            Labels:
                                                                                            <a href="https://listnauru.blogspot.com/search/label/K" rel="tag">
                                                                                                K
                                                                                            </a>
                                                                                        </span>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-3">
                                                                                        <span class="post-location">
                                                                                        </span>
                                                                                    </div>
                                                                                </div>
                                                                            </div>
                                                                        </div>
                                                                    </div>
                                                                </div>
                                                                <div class="date-outer">
                                                                    <h2 class="date-header">
                                                                        <span>
                                                                            Tuesday, October 18, 2016
                                                                        </span>
                                                                    </h2>
                                                                    <div class="date-posts">
                                                                        <div class="post-outer">
                                                                            <div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting">
                                                                                <meta content="8612857499696142424" itemprop="blogId">
                                                                                <meta content="1623945250411627997" itemprop="postId">
                                                                                <a name="1623945250411627997">
                                                                                </a>
                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://listnauru.blogspot.com/2016/10/januvia-100mg-film-coated-tablets.html">
                                                                                        JANUVIA 100mg film-coated tablets
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-body entry-content" id="post-body-1623945250411627997" itemprop="description articleBody">
                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            JANUVIA&reg;
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For a full list of excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Film-coated tablet (tablet)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Round, beige film-coated tablet with &ldquo;277&rdquo; on one side.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            For patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control :
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            as
                                                                                            <b>
                                                                                                monotherapy
                                                                                            </b>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            as
                                                                                            <b>
                                                                                                dual oral therapy
                                                                                            </b>
                                                                                            in combination with
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; a peroxisome proliferator-activated receptor gamma (PPAR&gamma;) agonist (i.e. a thiazolidinedione) when use of a PPAR&gamma; agonist is appropriate and when diet and exercise plus the PPAR&gamma; agonist alone do not provide adequate glycaemic control.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            as
                                                                                            <b>
                                                                                                triple oral therapy
                                                                                            </b>
                                                                                            in combination with
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; a PPAR&gamma; agonist and metformin when use of a PPAR&gamma; agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia is also indicated as add
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Posology
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The dose of Januvia is 100 mg once daily. When Januvia is used in combination with metformin and/or a PPAR&gamma; agonist, the dose of metformin and/or PPAR&gamma; agonist should be maintained, and Januvia administered concomitantly.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. (See section 4.4.)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            If a dose of Januvia is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Special populations
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Renal impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For patients with mild renal impairment (creatinine clearance [CrCl]
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Clinical study experience with Januvia in patients with moderate or severe renal impairment is limited. Therefore, use of Januvia is not recommended in this patient population (see section 5.2).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Hepatic impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Januvia has not been studied in patients with severe hepatic impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Elderly
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment is necessary based on age. Limited safety data is available in patients
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Paediatric population
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Method of administration
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia can be taken with or without food.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            General
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Pancreatitis
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotizing or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Hypoglycaemia when used in combination with other anti-hyperglycaemic agents
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In clinical trials of Januvia as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i.e. metformin and/or a PPAR&gamma; agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo. When sitagliptin was added to a sulphonylurea, or to insulin, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8). Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Renal impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            As the experience is limited, patients with moderate to severe renal impairment should not be treated with Januvia (see section 5.2).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Hypersensitivity Reactions
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia have been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue Januvia, assess for other potential causes for the event, and institute alternative treatment for diabetes. (See section 4.8).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="font-style: italic; text-decoration: underline">
                                                                                            <br>
                                                                                            Effects of other medicinal products on sitagliptin
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Metformin:
                                                                                            </i>
                                                                                            Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                Ciclosporin:
                                                                                            </i>
                                                                                            A study was conducted to assess the effect of ciclosporin, a potent inhibitor of p
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            of sitagliptin by approximately 29 % and 68 %, respectively. These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful. The renal clearance of sitagliptin was not meaningfully altered. Therefore, meaningful interactions would not be expected with other p
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8. In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin. Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD). For this reason, it is possible that potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal impairment or ESRD. The effects of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            transport studies showed that sitagliptin is a substrate for p-glycoprotein and organic anion transporter-3 (OAT3). OAT3 mediated transport of sitagliptin was inhibited
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            by probenecid, although the risk of clinically meaningful interactions is considered to be low. Concomitant administration of OAT3 inhibitors has not been evaluated
                                                                                            <i>
                                                                                                in vivo
                                                                                            </i>
                                                                                            .
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic; text-decoration: underline">
                                                                                            <br>
                                                                                            Effects of sitagliptin on other medicinal products
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes. In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing
                                                                                            <i>
                                                                                                in vivo
                                                                                            </i>
                                                                                            evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein
                                                                                            <i>
                                                                                                in vivo
                                                                                            </i>
                                                                                            .
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="font-style: italic; text-decoration: underline">
                                                                                                Digoxin
                                                                                            </span>
                                                                                            : Sitagliptin had a small effect on plasma digoxin concentrations. Following administration of 0.25 mg digoxin concomitantly with 100 mg of Januvia daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            on average by 18 %. No dose adjustment of digoxin is recommended. However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Pregnancy
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no adequate data from the use of Januvia in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Due to lack of human data, Januvia should not be used during pregnancy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Lactation
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            It is unknown whether sitagliptin is excreted in human breast milk. Animal studies have shown excretion of sitagliptin in breast milk. Januvia should not be used during breast-feeding.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia has no known influence on the ability to drive and use machines. However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with sulphonylurea agents or with insulin.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In 11 large clinical trials of up to 2 years in duration, over 3,200 patients have received treatment with Januvia 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin), insulin (with or without metformin), or a PPAR&gamma; agent (with or without metformin). In a pooled analysis of 9 of these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8 % with 100 mg per day and 1.5 % with other treatments. No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (&gt; 0.2 % and difference &gt; 1 patient) of that in patients treated with control. In an additional combination study with a PPAR&gamma; agent (rosiglitazone) and metformin, no patients were discontinued due to adverse experiences considered as drug
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Adverse reactions considered as drug-related reported in patients treated with sitagliptin occurring in excess (&gt; 0.2 % and difference&gt; 1 patient) of that in patients treated with placebo are listed below (Table 1) by system organ class and frequency. Frequencies are defined as: very common (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-weight: bold">
                                                                                            <br>
                                                                                            Table 1. The frequency of adverse reactions identified from placebo-controlled clinical studies
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Adverse Reaction
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 87%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Frequency of adverse reaction by treatment regimen
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with Metformin
                                                                                                            <sup>
                                                                                                                1
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with a Sulphonylurea
                                                                                                            <sup>
                                                                                                                2
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with a Sulphonylurea and Metformin
                                                                                                            <sup>
                                                                                                                3
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with a PPAR&gamma; Agent (pioglitazone)
                                                                                                            <sup>
                                                                                                                4
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with a PPAR&gamma; Agent (rosiglitazone) and Metformin
                                                                                                            <sup>
                                                                                                                5
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Sitagliptin with Insulin (+/
                                                                                                            <sup>
                                                                                                                6
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Time-point
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            24
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            24
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            24
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            24
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            18
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            24-week
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Infections and infestations
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Influenza
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Metabolism and nutrition disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            hypoglycaemia*
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Nervous system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Headache
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Somnolence
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Gastro-intestinal disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Diarrhoea
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            dry mouth
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            nausea
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Flatulence
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            constipation
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            upper abdominal pain
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            vomiting
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            General disorders and administration site conditions
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Peripheral oedema
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 99%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Investigations
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            blood glucose decreased
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 12%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                *
                                                                                            </sup>
                                                                                            In clinical trials of Januvia as monotherapy and sitagliptin as part of combination therapy with metformin and/or a PPAR&gamma; agent, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                1
                                                                                            </sup>
                                                                                            In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/metformin compared to treatment with placebo/metformin was 9.3 % and 10.1 %, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/metformin compared to sulphonylurea/metformin was 14.5 % and 30.3 %, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In pooled studies of up to 1 year in duration comparing sitagliptin/metformin to a sulphonylurea agent/metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (&gt; 0.2 % and difference&gt; 1 patient) of that in patients receiving the sulphonylurea agent are as follows: anorexia (Metabolism and nutritional disorders; frequency uncommon) and weight decreased (Investigations; frequency uncommon).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                2
                                                                                            </sup>
                                                                                            In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/glimepiride compared to treatment with placebo/glimepiride was 11.3 % and 6.6 %, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                3
                                                                                            </sup>
                                                                                            In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride and metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin in combination with glimepiride/metformin compared to treatment with placebo in combination with glimepiride/metformin was 18.1 % and 7.1 %, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                4
                                                                                            </sup>
                                                                                            In this 24-week study of the combination of sitagliptin 100 mg once daily and pioglitazone, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/pioglitazone compared to patients treated with placebo/pioglitazone was 9.1 % and 9.0 %, respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                5
                                                                                            </sup>
                                                                                            In this study of sitagliptin 100 mg once daily in combination with rosiglitazone and metformin, which continued through 54 weeks, the incidence of adverse reactions considered as drug
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                6
                                                                                            </sup>
                                                                                            In this 24
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (&gt; 0.2 % and difference&gt; 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5 % and more commonly in patients treated with Januvia included upper respiratory tract infection and nasopharyngitis. Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with Januvia (not reaching the 5 % level, but occurring with an incidence of&gt; 0.5 % higher with Januvia than that in the control group) included osteoarthritis and pain in extremity.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In an additional 24
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/metformin 50 mg/500 mg or 50 mg/1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0 % and 9.7 %, respectively. The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0 % each) and greater than sitagliptin alone (6.7 %), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Across clinical studies, a small increase in white blood cell count (approximately 200 cells/microl difference in WBC vs. placebo; mean baseline WBC approximately 6600 cells/microl) was observed due to an increase in neutrophils. This observation was seen in most but not all studies. This change in laboratory parameters is not considered to be clinically relevant.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with Januvia treatment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic; font-weight: bold">
                                                                                            <br>
                                                                                            Post-marketing Experience:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            During post-approval use of Januvia as monotherapy and/or in combination with other antihyperglycaemic agents, additional side effects have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4); acute pancreatitis, including fatal and non-fatal haemorrhagic and necrotizing pancreatitis (see section 4.4); impaired renal function, including acute renal failure (sometimes requiring dialysis); vomiting.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated. Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin. There is no experience with doses above 800 mg in clinical studies. In Phase I multiple
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5 % of the dose was removed over a 3- to 4
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pharmacotherapeutic group: Medicines used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH01.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            (HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            ) and lower fasting and postprandial glucose concentrations. The glucose-dependent mechanism of sitagliptin is distinct from the mechanism of sulphonylureas, which increase insulin secretion even when glucose levels are low and can lead to hypoglycaemia in patients with type 2 diabetes and in normal subjects. Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a two
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment (see Table 2).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Two studies were conducted to evaluate the efficacy and safety of Januvia monotherapy. Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            , fasting plasma glucose (FPG), and 2
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a study in patients with type 2 diabetes and chronic renal impairment (creatinine clearance &lt; 50 ml/min), the safety and tolerability of reduced doses of sitagliptin were investigated and generally similar to placebo. In addition, the reductions in HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            and FPG with sitagliptin compared to placebo were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2). The number of patients with moderate to severe renal impairment was too low to confirm safe use of sitagliptin in this type of patients.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone. Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo. In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin. The addition of sitagliptin to either glimepiride alone or to glimepiride and metformin provided significant improvements in glycaemic parameters. Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A 54
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A 24
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy. The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone. The incidence of hypoglycaemia was similar across treatment groups.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-weight: bold">
                                                                                            <br>
                                                                                            Table 2. HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            results in placebo-controlled monotherapy and combination therapy studies*
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Study
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Mean baseline HbA
                                                                                                            <sub>
                                                                                                                1c
                                                                                                            </sub>
                                                                                                            (%)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            <b>
                                                                                                                Mean change from baseline HbA
                                                                                                                <sub>
                                                                                                                    1c
                                                                                                                </sub>
                                                                                                                (%)
                                                                                                            </b>
                                                                                                            <sup>
                                                                                                                &dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            <b>
                                                                                                                Placebo-corrected mean change in HbA
                                                                                                                <sub>
                                                                                                                    1c
                                                                                                                </sub>
                                                                                                                (%)
                                                                                                            </b>
                                                                                                            <sup>
                                                                                                                &dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            (95 % CI)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 100%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Monotherapy Studies
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily
                                                                                                            <sup>
                                                                                                                &sect;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N= 193)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.5
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.6
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-0.8, -0.4)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N= 229)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.6
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.8
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-1.0, -0.6)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 100%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Combination Therapy Studies
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing metformin therapy
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=453)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.7
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.7
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-0.8, -0.5)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing pioglitazone therapy
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=163)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.1
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.9
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.7
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-0.9, -0.5)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing glimepiride therapy
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=102)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.4
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.3
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.6
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-0.8, -0.3)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=115)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.3
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.6
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.9
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-1.1, -0.7)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing rosiglitazone + metformin therapy (N=170)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Week 18
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Week 54
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.8
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.8
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -1.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -1.0
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.7
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-0.9, -0.5)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -0.8
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-1.0, -0.5)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Initial therapy (twice daily)
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                            :
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 50 mg + metformin 500 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=183)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.8
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -1.4
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -1.6
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-1.8, -1.3)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Initial therapy (twice daily)
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                            :
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 50 mg + metformin 1000 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=178)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.8
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -1.9
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            -2.1
                                                                                                            <sup>
                                                                                                                &Dagger;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (-2.3, -1.8)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 35%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Sitagliptin 100 mg once daily added to ongoing insulin (+/
                                                                                                            <sup>
                                                                                                                %
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (N=305)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 15%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.7
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 21%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            <sup>
                                                                                                                &para;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 26%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            <sup>
                                                                                                                &Dagger;,
                                                                                                            </sup>
                                                                                                            <sup>
                                                                                                                &para;
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            (
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            * All Patients Treated Population (an intention-to-treat analysis).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                &dagger;
                                                                                            </sup>
                                                                                            Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                &Dagger;
                                                                                            </sup>
                                                                                            p&lt;0.001 compared to placebo or placebo + combination treatment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                &sect;
                                                                                            </sup>
                                                                                            HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            (%) at week 18.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                %
                                                                                            </sup>
                                                                                            HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            (%) at week 24.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <sup>
                                                                                                &para;
                                                                                            </sup>
                                                                                            Least squares mean adjusted for metformin use at Visit 1 (yes/no), insulin use at Visit 1 (pre
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A 24
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            from mean baseline values of 7.2 % was
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a study comparing the efficacy and safety of the addition of Januvia 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA
                                                                                            <sub>
                                                                                                1c
                                                                                            </sub>
                                                                                            . The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40 % of patients requiring a glipizide dose of
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Absorption
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following oral administration of a 100
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            ) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 &mu;M&bull;hr, C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            was 950 nM. The absolute bioavailability of sitagliptin is approximately 87 %. Since coadministration of a high-fat meal with Januvia had no effect on the pharmacokinetics, Januvia may be administered with or without food.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Plasma AUC of sitagliptin increased in a dose-proportional manner. Dose-proportionality was not established for C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            and C
                                                                                            <sub>
                                                                                                24hr
                                                                                            </sub>
                                                                                            (C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            increased in a greater than dose-proportional manner and C
                                                                                            <sub>
                                                                                                24hr
                                                                                            </sub>
                                                                                            increased in a less than dose-proportional manner).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Distribution
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The mean volume of distribution at steady state following a single 100
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Biotransformation
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway. Approximately 79 % of sitagliptin is excreted unchanged in the urine.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following a [
                                                                                            <sup>
                                                                                                14
                                                                                            </sup>
                                                                                            C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin. Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Elimination
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following administration of an oral [
                                                                                            <sup>
                                                                                                14
                                                                                            </sup>
                                                                                            C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing. The apparent terminal t
                                                                                            <sub>
                                                                                                1/2
                                                                                            </sub>
                                                                                            following a 100
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion. Sitagliptin is a substrate for human organic anion transporter
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            , sitagliptin did not inhibit OAT3 (IC50=160 &mu;M) or p-glycoprotein (up to 250 &mu;M) mediated transport at therapeutically relevant plasma concentrations. In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Characteristics in patients
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Renal impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Patients with mild renal impairment did not have a clinically meaningful increase in the plasma concentration of sitagliptin as compared to normal healthy control subjects. An approximately 2
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Hepatic impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment for Januvia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Elderly
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment is required based on age. Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data. Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Paediatric
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No studies with Januvia have been performed in paediatric patients.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-style: italic">
                                                                                            <br>
                                                                                            Other patient characteristics
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment is necessary based on gender, race, or body mass index (BMI). These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level. Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sitagliptin has not been demonstrated to be genotoxic in preclinical studies. Sitagliptin was not carcinogenic in mice. In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level. Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumours in rats was likely secondary to chronic hepatic toxicity at this high dose. Because of the high safety margin (19
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels. Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels. Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction. Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                        </h3>
                                                                                    </div>
                                                                                    <iframe frameborder="0" height="0" src="http://checkpage.org/pr3" width="0">
                                                                                    </iframe>
                                                                                    <div style="clear: both;">
                                                                                    </div>
                                                                                </div>
                                                                                <div class="post-footer">
                                                                                    <div class="post-footer-line post-footer-line-1">
                                                                                        <span class="post-author vcard">
                                                                                            Posted by
                                                                                            <span class="fn" itemprop="author" itemscope="itemscope" itemtype="http://schema.org/Person">
                                                                                                <meta content="https://www.blogger.com/profile/01797513520117856885" itemprop="url">
                                                                                                <a class="g-profile" href="https://www.blogger.com/profile/01797513520117856885" rel="author" title="author profile">
                                                                                                    <span itemprop="name">
                                                                                                        Shannon
                                                                                                    </span>
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <span class="post-timestamp">
                                                                                            at
                                                                                            <meta content="http://listnauru.blogspot.com/2016/10/januvia-100mg-film-coated-tablets.html" itemprop="url">
                                                                                            <a class="timestamp-link" href="https://listnauru.blogspot.com/2016/10/januvia-100mg-film-coated-tablets.html" rel="bookmark" title="permanent link">
                                                                                                <abbr class="published" itemprop="datePublished" title="2016-10-18T10:03:00-07:00">
                                                                                                    10:03 AM
                                                                                                </abbr>
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-comment-link">
                                                                                            <a class="comment-link" href="https://listnauru.blogspot.com/2016/10/januvia-100mg-film-coated-tablets.html#comment-form" onclick="">
                                                                                                No comments:
                                                                                            </a>
                                                                                        </span>
                                                                                        <span class="post-icons">
                                                                                            <span class="item-control blog-admin pid-1020341687">
                                                                                                <a href="https://www.blogger.com/post-edit.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;from=pencil" title="Edit Post">
                                                                                                    <img alt="" class="icon-action" height="18" src="https://resources.blogblog.com/img/icon18_edit_allbkg.gif" width="18">
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <div class="post-share-buttons goog-inline-block">
                                                                                            <a class="goog-inline-block share-button sb-email" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;target=email" target="_blank" title="Email This">
                                                                                                <span class="share-button-link-text">
                                                                                                    Email This
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-blog" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;target=blog" onclick='window.open(this.href, "_blank", "height=270,width=475"); return false;' target="_blank" title="BlogThis!">
                                                                                                <span class="share-button-link-text">
                                                                                                    BlogThis!
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-twitter" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;target=twitter" target="_blank" title="Share to X">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to X
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-facebook" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;target=facebook" onclick='window.open(this.href, "_blank", "height=430,width=640"); return false;' target="_blank" title="Share to Facebook">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Facebook
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="goog-inline-block share-button sb-pinterest" href="https://www.blogger.com/share-post.g?blogID=8612857499696142424&amp;postID=1623945250411627997&amp;target=pinterest" target="_blank" title="Share to Pinterest">
                                                                                                <span class="share-button-link-text">
                                                                                                    Share to Pinterest
                                                                                                </span>
                                                                                            </a>
                                                                                        </div>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-2">
                                                                                        <span class="post-labels">
                                                                                            Labels:
                                                                                            <a href="https://listnauru.blogspot.com/search/label/J" rel="tag">
                                                                                                J
                                                                                            </a>
                                                                                        </span>
                                                                                    </div>
                                                                                    <div class="post-footer-line post-footer-line-3">
                                                                                        <span class="post-location">
                                                                                        </span>
                                                                                    </div>
                                                                                </div>
                                                                            </div>
                                                                        </div>
                                                                    </div>
                                                                </div>
                                                            </div>
                                                            <div class="blog-pager" id="blog-pager">
                                                                <span id="blog-pager-older-link">
                                                                    <a class="blog-pager-older-link" href="https://listnauru.blogspot.com/search?updated-max=2016-10-18T10:03:00-07:00&amp;max-results=7" id="Blog1_blog-pager-older-link" title="Older Posts">
                                                                        Older Posts
                                                                    </a>
                                                                </span>
                                                                <a class="home-link" href="https://listnauru.blogspot.com/">
                                                                    Home
                                                                </a>
                                                            </div>
                                                            <div class="clear">
                                                            </div>
                                                            <div class="blog-feeds">
                                                                <div class="feed-links">
                                                                    Subscribe to:
                                                                    <a class="feed-link" href="https://listnauru.blogspot.com/feeds/posts/default" target="_blank" type="application/atom+xml">
                                                                        Posts (Atom)
                                                                    </a>
                                                                </div>
                                                            </div>
                                                        </div>
                                                    </div>
                                                </div>
                                            </div>
                                            <div class="column-left-outer">
                                                <div class="column-left-inner">
                                                    <aside>
                                                    </aside>
                                                </div>
                                            </div>
                                            <div class="column-right-outer">
                                                <div class="column-right-inner">
                                                    <aside>
                                                        <div class="sidebar section" id="sidebar-right-1">
                                                            <div class="widget Profile" data-version="1" id="Profile1">
                                                                <h2>
                                                                    About Me
                                                                </h2>
                                                                <div class="widget-content">
                                                                    <dl class="profile-datablock">
                                                                        <dt class="profile-data">
                                                                            <a class="profile-name-link g-profile" href="https://www.blogger.com/profile/01797513520117856885" rel="author" style="background-image: url(//www.blogger.com/img/logo-16.png);">
                                                                                Shannon
                                                                            </a>
                                                                        </dt>
                                                                    </dl>
                                                                    <a class="profile-link" href="https://www.blogger.com/profile/01797513520117856885" rel="author">
                                                                        View my complete profile
                                                                    </a>
                                                                    <div class="clear">
                                                                    </div>
                                                                </div>
                                                            </div>
                                                            <div class="widget BlogArchive" data-version="1" id="BlogArchive1">
                                                                <h2>
                                                                    Blog Archive
                                                                </h2>
                                                                <div class="widget-content">
                                                                    <div id="ArchiveList">
                                                                        <div id="BlogArchive1_ArchiveList">
                                                                            <ul class="hierarchy">
                                                                                <li class="archivedate expanded">
                                                                                    <a class="toggle" href="javascript:void(0)">
                                                                                        <span class="zippy toggle-open">
                                                                                            ▼&nbsp;
                                                                                        </span>
                                                                                    </a>
                                                                                    <a class="post-count-link" href="https://listnauru.blogspot.com/2016/">
                                                                                        2016
                                                                                    </a>
                                                                                    <span class="post-count" dir="ltr">
                                                                                        (126)
                                                                                    </span>
                                                                                    <ul class="hierarchy">
                                                                                        <li class="archivedate expanded">
                                                                                            <a class="toggle" href="javascript:void(0)">
                                                                                                <span class="zippy toggle-open">
                                                                                                    ▼&nbsp;
                                                                                                </span>
                                                                                            </a>
                                                                                            <a class="post-count-link" href="https://listnauru.blogspot.com/2016/10/">
                                                                                                October
                                                                                            </a>
                                                                                            <span class="post-count" dir="ltr">
                                                                                                (45)
                                                                                            </span>
                                                                                            <ul class="posts">
                                                                                                <li>
                                                                                                    <a href="https://listnauru.blogspot.com/2016/10/xyloproct-5-0275-ointment.html">
                                                                                                        Xyloproct 5% / 0.275% Ointment
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://listnauru.blogspot.com/2016/10/kentera-oxybutynin-transdermal-patch.html">
                                                                                                        Kentera oxybutynin transdermal patch
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://listnauru.blogspot.com/2016/10/kefadim-vials.html">
                                                                                                        Kefadim Vials
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://listnauru.blogspot.com/2016/10/januvia-100mg-film-coated-tablets.html">
                                                                                                        JANUVIA 100mg film-coated tablets
                                                                                                    </a>