Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="0817Bundle"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="https://www.mhra.gov.uk/"/>
<value value="0817BundleUniqueIdentifier"/>
</identifier>
<type value="document"/>
<timestamp value="2022-03-04T00:00:00Z"/>
<entry>
<fullUrl value="Composition/0818TestandLearn"/>
<resource>
<Composition>
<id value="0818TestandLearn"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_0818TestandLearn"> </a><p><b>Generated Narrative: Composition</b><a name="0818TestandLearn"> </a><a name="hc0818TestandLearn"> </a></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 "0818TestandLearn" (Language "en") </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.mhra.gov.uk/</code>/c387d81a-3b28-11ee-be56-0242ac120002</p><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>: 2022-03-04 00:00:00+0000</p><p><b>author</b>: See on this page: Organization/0817Org</p><p><b>title</b>: 0818TestandLearnTitle2 input in code row 18</p></div>
</text>
<identifier>
<system value="https://www.mhra.gov.uk/"/>
<value value="c387d81a-3b28-11ee-be56-0242ac120002"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<date value="2022-03-04T00:00:00Z"/>
<author>🔗
<reference value="Organization/0817Org"/>
</author>
<title value="0818TestandLearnTitle2 input in code row 18"/>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><ol><li>What Talzenna is and what it is used for</li><li>What you need to know before you take Talzenna</li><li>How to take Talzenna</li><li>Possible side effects</li><li>How to store Talzenna</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What Talzenna is and what it is used for"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029895"/>
</coding>
<text value="1. What Talzenna is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="What Talzenna is and how it works"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029895"/>
</coding>
<text value="What Talzenna is and how it works"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor’.</p><p>Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and they die.</p></div>
</text>
</section>
<section>
<title value="What Talzenna is used for"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029895"/>
</coding>
<text value="What Talzenna is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene.</p><p>Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.</p><p>Your healthcare provider will perform a test to make sure that Talzenna is right for you.</p><p>If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.</p></div>
</text>
</section>
</section>
<section>
<title value="2. What you need to know before you take Talzenna"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029896"/>
</coding>
<text value="2. What you need to know before you take Talzenna"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="Do not take Talzenna"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029897"/>
</coding>
<text value="Do not take Talzenna"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><ul><li>If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in section 6)</li><li>f you are breast-feeding.</li></ul></div>
</text>
</section>
<section>
<title value="Warnings and precautions"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="200000029898"/>
</coding>
<text value="Warnings and precautions"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you experience signs or symptoms described in this section.</p><p><b>Low blood cell counts</b></p><p>Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:</p><ul><li><b>Anaemia:</b> Being short of breath, feeling very tired, pale skin, or fast heartbeat – these may be signs of a low red blood cell count</li><li><b>Neutropenia:</b> Infection, developing chills or shivering, or fever – these may be signs of a low white blood cell count</li><li><b>Thrombocytopenia:</b> Bruising or bleeding for longer than usual if you hurt yourself – these may be signs of a low blood platelet count</li></ul><p>Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). Signs and symptoms you need to look out for include:</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="Organization/0817Org"/>
<resource>
<Organization>
<id value="0817Org"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_0817Org"> </a><p><b>Generated Narrative: Organization</b><a name="0817Org"> </a><a name="hc0817Org"> </a></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 Organization "0817Org" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/0817org01 (use: official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#220000000034)</span></p><p><b>name</b>: Willywonka Factory</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>221B Baker Street, London NW1 6XE(work)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="0817org01"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
<text value="Marketing authorisation holder"/>
</type>
<name value="Willywonka Factory"/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="221B Baker Street, London NW1 6XE"/>
<line value="Baker Street"/>
<city value="London"/>
<country value="UK"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2022+ . Package hl7.fhir.uv.epi-test#0.1.0 based on FHIR 5.0.0. Generated 2024-04-04
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
