Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

: cfsb1651231019151 - XML Representation

Raw xml | Download



<Composition xmlns="http://hl7.org/fhir">
  <id value="cfsb1651231019151"/>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p><b>Generated Narrative: Composition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition "cfsb1651231019151"  (Language "en") </p></div><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000155538)</span></p><p><b>date</b>: 2022-04-29 01:28:17+0000</p><p><b>author</b>: <a href="Organization-cfsb1651149636159.html">Organization/cfsb1651149636159</a> "ViiV Healthcare BV"</p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><p><b>confidentiality</b>: U</p><h3>Attesters</h3><table class="grid"><tr><td>-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td>*</td><td>Official <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://build.fhir.org/codesystem-composition-attestation-mode.html">CompositionAttestationMode</a>#official)</span></td><td>2002-08-01 01:28:17+0000</td></tr></table></div>
  </text>
  <status value="final"/>
  <type>
    <coding>
      <system value="https://spor.ema.europa.eu/"/>
      <code value="100000155538"/>
    </coding>
    <text value="Package Leaflet"/>
  </type>
  <subject>
    <reference value="RegulatedAuthorization/cfsb1651148079894"/>
  </subject>
  <date value="2022-04-29T13:28:17Z"/>
  <author>
    <reference value="Organization/cfsb1651149636159"/>
  </author>
  <title value="TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets"/>
  <confidentiality value="U"/>
  <attester>
    <mode>
      <coding>
        <system value="http://hl7.org/fhir/composition-attestation-mode"/>
        <code value="official"/>
      </coding>
    </mode>
    <time value="2002-08-01T13:28:17Z"/>
  </attester>
  <section>
    <title value="B. Package Leaflet"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml">Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.<ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
    </text>
  </section>
  <section>
    <title value="What is in this leaflet"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-0"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml">What in this leaflet<ol><li>What Dovato is and what it is used for</li><li>What you need to know before you take Dovato</li><li>How to take Dovato</li><li>Possible side effects</li><li>How to store Dovato</li><li>Contents of the pack and other information</li></ol></div>
    </text>
  </section>
  <section>
    <title value="1. What Dovato is and what it is used for"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-1"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><b>1. What Dovato is and what it is used for</b> Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.</div>
    </text>
  </section>
  <section>
    <title value="2. What you need to know before you take Dovato"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-2"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><b>2. What you need to know before you take Dovato</b> Do not take Dovato<ul><li>if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).</li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>
    </text>
  </section>
  <section>
    <title value="3. How to take Dovato"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-3"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><b>How to take Dovato</b><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure</p><ul><li>The recommended dose of Dovato is <b>one tablet once a day.</b></li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>
    </text>
  </section>
  <section>
    <title value="4. Possible side effects"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-4"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p><b>4. Possible side effects</b></p><p>Like all medicines, this medicine can cause side effects, although not everybody gets them,<b>so it is very important to talk to your doctor about any changes in your health</b></p></div>
    </text>
  </section>
  <section>
    <title value="5. How to store Dovato"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-5"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><b>5. How to store Dovato</b><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>
    </text>
  </section>
  <section>
    <title value="6. Contents of the pack and other information"/>
    <code>
      <coding>
        <system value="https://spor.ema.europa.eu/"/>
        <code value="100000155538-6"/>
      </coding>
      <text value="B. PACKAGE LEAFLET"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><b>6. Contents of the pack and other information</b> <b>What Dovato contains</b><ul><li>The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.</li><li>The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).</li><li>This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.</li></ul></div>
    </text>
  </section>
</Composition>