<section>  <title value="1. NAME OF THE MEDICINAL PRODUCT" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000021212" /> <display value="Name Section" /> </coding> </code>  <text>  <status value="additional" />    <div xmlns="http://www.w3.org/1999/xhtml"> <div>Karvea 75 mg film-coated tablets</div> </div> </text>  </section> <section>  <title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000021213" />  <display value="Composition" /> </coding> </code>  <text>  <status value="additional" />    <div xmlns="http://www.w3.org/1999/xhtml"> <p>Each tablet contains 75 mg of irbesartan.</p> <br /> <p> <span style="text-decoration:underline">Excipient with known effect</span> <span>: 15.37 mg of lactose monohydrate per tablet.</span> </p> <br /> <p>For the full list of excipients, see section 6.1.</p> </div> </text>  </section> <section>  <title value="3. PHARMACEUTICAL FORM" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000031313" /> <display value="Form" /> </coding> </code>  <text>  <status value="additional" />    <div xmlns="http://www.w3.org/1999/xhtml"> <p>Tablet.</p> <p>White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.</p> </div> </text>  </section> <section>  <title value="4. CLINICAL PARTICULARS" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="0000002223333" /> <display value="clinical-particulars" /> </coding> </code>    <section>  <title value="4.1 Therapeutic indications" /> <code> <coding> <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000044444" /> <display value="Therapeutic Indications" /> </coding> </code> <text>  <status value="additional" />  <div xmlns="http://www.w3.org/1999/xhtml"> <p>Karvea is indicated in adults for the treatment of essential hypertension.</p> <p>It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).</p> </div> </text> </section>  <section>  <title value="4.2 Posology and method of administration" /> <code> <coding> <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="0000005555" /> <display value="Posology" /> </coding> </code> <text>  <status value="additional" />  <div xmlns="http://www.w3.org/1999/xhtml"> <p style="text-decoration:underline">Posology</p> <br /> <p>The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.</p> <br /> <p>In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).</p> <br /> <p>In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). </p> <br /> <p>Example of a table:</p> <table> <tr> <th>Heading 1</th> <th>Heading 2</th> </tr> <tr> <td>Some text</td>  <td> <img src="#imageResource" alt="an image" /> </td> </tr> </table> </div> </text> </section> </section>  </Composition> </resource> </entry>  <entry> <fullUrl value="urn:uuid:812a430c-0eda-4615-a30b-a760edaa3597" /> <resource> <List> <status value="current" /> <mode value="working" /> <entry>  <item> <reference value="MedicinalProductDefinition/Karvea75" /> <display value="Karvea 75 mg tablets" /> </item> </entry> </List> </resource> </entry> </Bundle>


        
          
            
              
              
              
            
          
          
          
          
          
          
          
        
        
        
        
          
            
            
          
        
        
        <!-- removed 2021-07-07 no longer using relatesTo -->
        <!-- main sections of the document, to follow the QRD template -->
        <section>
          <!-- Section 1-->
          <title value="1. NAME OF THE MEDICINAL PRODUCT" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="00000021212" />
              <display value="Name Section" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <text>
            <!-- Section 1-->
            <status value="additional" />
            <!-- HTML goes here, must start with
  									<div xmlns="http://www.w3.org/1999/xhtml">
  									-->
            <!-- any xhtml is valid, with a few exceptions
  											(e.g. head, body, scripts etc).
  										    See http://hl7.org/fhir/narrative.html#Narrative -->
            <!-- Doc: 1 Section: 1 Subsection: 0-->
            <div xmlns="http://www.w3.org/1999/xhtml">
              <div>Karvea 75 mg film-coated tablets</div>
            </div>
          </text>
          <!-- a section within a section -->
        </section>
        <section>
          <!-- Section 2-->
          <title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="00000021213" />
              <!-- change here to remove repeated example code 2021-06-11 -->
              <display value="Composition" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <text>
            <!-- Section 2-->
            <status value="additional" />
            <!-- HTML goes here, must start with
  									<div xmlns="http://www.w3.org/1999/xhtml">
  									-->
            <!-- any xhtml is valid, with a few exceptions
  											(e.g. head, body, scripts etc).
  										    See http://hl7.org/fhir/narrative.html#Narrative -->
            <!-- Doc: 1 Section: 2 Subsection: 0-->
            <div xmlns="http://www.w3.org/1999/xhtml">
              <p>Each tablet contains 75 mg of irbesartan.</p>
              <br />
              <p>
                <span style="text-decoration:underline">Excipient with known effect</span>
                <span>:  15.37 mg of lactose monohydrate per tablet.</span>
              </p>
              <br />
              <p>For the full list of excipients, see section 6.1.</p>
            </div>
          </text>
          <!-- a section within a section -->
        </section>
        <section>
          <!-- Section 3-->
          <title value="3. PHARMACEUTICAL FORM" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="00000031313" />
              <display value="Form" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <text>
            <!-- Section 3-->
            <status value="additional" />
            <!-- HTML goes here, must start with
  									<div xmlns="http://www.w3.org/1999/xhtml">
  									-->
            <!-- any xhtml is valid, with a few exceptions
  											(e.g. head, body, scripts etc).
  										    See http://hl7.org/fhir/narrative.html#Narrative -->
            <!-- Doc: 1 Section: 3 Subsection: 0-->
            <div xmlns="http://www.w3.org/1999/xhtml">
              <p>Tablet.</p>
              <p>White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.</p>
            </div>
          </text>
          <!-- a section within a section -->
        </section>
        <section>
          <!-- Section 4-->
          <title value="4. CLINICAL PARTICULARS" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="0000002223333" />
              <display value="clinical-particulars" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <!-- a section within a section -->
          <!-- Sub-section 1-->
          <section>
            <!-- Sub-Section 1-->
            <title value="4.1 Therapeutic indications" />
            <code>
              <coding>
                <system value="http://spor.ema.europa.eu/v1/example-sections" />
                <code value="00000044444" />
                <display value="Therapeutic Indications" />
              </coding>
            </code>
            <text>
              <!-- Section 4-->
              <status value="additional" />
              <!-- Doc: 1 Section: 4 Subsection: 1-->
              <div xmlns="http://www.w3.org/1999/xhtml">
                <p>Karvea is indicated in adults for the treatment of essential hypertension.</p>
                <p>It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2
                              diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5
                              and 5.1).</p>
              </div>
            </text>
          </section>
          <!-- Sub-section 2-->
          <section>
            <!-- Sub-Section 2-->
            <title value="4.2 Posology and method of administration" />
            <code>
              <coding>
                <system value="http://spor.ema.europa.eu/v1/example-sections" />
                <code value="0000005555" />
                <display value="Posology" />
              </coding>
            </code>
            <text>
              <!-- Section 4-->
              <status value="additional" />
              <!-- Doc: 1 Section: 4 Subsection: 2-->
              <div xmlns="http://www.w3.org/1999/xhtml">
                <p style="text-decoration:underline">Posology</p>
                <br />
                <p>The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
                              Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than
                              75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed
                              patients and in the elderly over 75 years.</p>
                <br />
                <p>In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to
                              300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In
                              particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive
                              effect with Karvea (see section 4.5).</p>
                <br />
                <p>In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily
                              and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
                              The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on
                              studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach
                              target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
                          </p>
                <br />
                <p>Example of a table:</p>
                <table>
                  <tr>
                    <th>Heading 1</th>
                    <th>Heading 2</th>
                  </tr>
                  <tr>
                    <td>Some text</td>
                    <!-- possible to link images to embedded Binary resources (contained resources) -->
                    <td>
                      <img src="#imageResource" alt="an image" />
                    </td>
                  </tr>
                </table>
              </div>
            </text>
          </section>
        </section>
        <!-- sections can repeat as necessary -->
      </Composition>
    </resource>
  </entry>
  <!-- an entry that is a list of PMS Product references -->
  <entry>
    <fullUrl value="urn:uuid:812a430c-0eda-4615-a30b-a760edaa3597" />
    <resource>
      <List>
        <status value="current" />
        <mode value="working" />
        <entry>
          <!-- Product 1-->
          <item>
            <reference value="MedicinalProductDefinition/Karvea75" />
            <display value="Karvea 75 mg tablets" />
          </item>
        </entry>
      </List>
    </resource>
  </entry>
</Bundle>