Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. 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/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-684d3ac7eb172f49f26955be7ae4a00d"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="None"/>
</identifier>
<type value="document"/>
<timestamp value="2023-06-27T10:09:22Z"/>
<entry>
<fullUrl
value="Composition/composition-en-684d3ac7eb172f49f26955be7ae4a00d"/>
<resource>
<Composition>
<id value="composition-en-684d3ac7eb172f49f26955be7ae4a00d"/>
<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_composition-en-684d3ac7eb172f49f26955be7ae4a00d"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-684d3ac7eb172f49f26955be7ae4a00d</b></p><a name="composition-en-684d3ac7eb172f49f26955be7ae4a00d"> </a><a name="hccomposition-en-684d3ac7eb172f49f26955be7ae4a00d"> </a><a name="composition-en-684d3ac7eb172f49f26955be7ae4a00d-en-US"> </a><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">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>http://ema.europa.eu/identifier</code>/EU/1/19/1358/001 – 1 pre-filled syringe</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}">Package Leaflet</span></p><p><b>category</b>: <span title="Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href="Organization-mah-ema.html">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - ajovy</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/composition-attestation-mode official}">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/19/1358/001 – 1 pre-filled syringe"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<category>
<coding>
<system
value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
<code value="R"/>
<display value="Raw"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mp684d3ac7eb172f49f26955be7ae4a00d"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - ajovy"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2022-02-16T13:28:17Z"/>
</attester>
<section>
<title value="B. Package Leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="B. Package Leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="Package leaflet: Information for the user"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package leaflet: Information for the user"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What AJOVY is and what it is used for</li><li>What you need to know before you use AJOVY</li><li>How to use AJOVY</li><li>Possible side effects</li><li>How to store AJOVY</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What ajovy is and what it is used for"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What ajovy is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What AJOVY is AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.</p><p>How AJOVY works A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working. This reduction in CGRP's activity reduces migraine attacks.</p><p>What AJOVY is used for AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.</p><p>What are the benefits of using AJOVY AJOVY reduces the frequency of migraine attacks and days with headache. This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take ajovy"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="2. What you need to know before you take ajovy"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use AJOVY Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).</p><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse immediately if you get any signs of a serious allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY. These reactions can occur within 24 hours after using AJOVY but can sometimes be delayed.</p><p>Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.</p><p>Children and adolescents AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.</p><p>Other medicines and AJOVY Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.</p><p>Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.</p><p>If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding.</p><p>Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines.</p><p>AJOVY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially sodium-free .</p></div>
</text>
</section>
<section>
<title value="3. How to take ajovy"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take ajovy"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>Read the Instructions for Use for the pre-filled syringe carefully before using AJOVY.</p><p>How much and when to inject Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two alternative recommended dosing options:</p><ul><li>one injection (225 mg) once a month (monthly dosing) or</li><li>three injections (675 mg) every 3 months (quarterly dosing)</li></ul><p>If your dose is 675 mg, inject the three injections one after another, each in a different place.</p><p>AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.</p><p>Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.</p><p>If you use more AJOVY than you should If you have used more AJOVY than you should, tell your doctor.</p><p>If you forget or miss to use AJOVY If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to your doctor, pharmacist or nurse.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="4. Possible side effects"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>The following side effects can occur:</p><p>Very common (may affect more than 1 in 10 people) Pain, hardening or redness at the injection site</p><p>Common (may affect up to 1 in 10 people) Itching at the injection site</p><p>Uncommon (may affect up to 1 in 100 people) Rash at the injection site Allergic reactions such as rash, swelling or hives</p><p>Rare (may affect up to 1 in 1,000 people) Serious allergic reactions (signs may include trouble breathing, swelling of the lips, tongue or severe rash) (see section 2. Warnings and precautions ).</p><p>Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.</p></div>
</text>
</section>
<section>
<title value="5. How to store ajovy"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store ajovy"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><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 syringe label and on the outer carton after EXP. The expiry date refers to the last day of that month.</p><p>Store in a refrigerator (2 C 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton to protect the medicine from light.</p><p>This medicine may be removed from the refrigerator and stored at a temperature up to 30 C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in the refrigerator.</p><p>Do not use this medicine if you notice that the outer carton has been tampered with, the syringe is damaged, or the medicine is cloudy, discoloured, or contains particles.</p><p>The syringe is for single use only.</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/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="6. Contents of the pack and other information"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What AJOVY contains</p><ul><li>The active substance is fremanezumab.<br/>Each pre-filled syringe contains 225 mg of fremanezumab.</li><li>The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.</li></ul><p>What AJOVY looks like and contents of the pack AJOVY is a solution for injection (injection) in a pre-filled syringe with a fixed injection needle in a blister. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled syringe contains 1.5 mL solution.</p><p>AJOVY is available in packs containing 1 or 3 pre-filled syringes. Not all pack sizes may be available in your country.</p><p>Marketing Authorisation Holder<br/>TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany</p><p>Manufacturer Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany</p><p>Teva Pharmaceuticals Europe B.V. Swensweg 5 2031 GA Haarlem The Netherlands</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660</p><p>Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt.<br/>Tel: +36 12886Danmark Teva Denmark A/S<br/>Tlf: +45 44985Malta Teva Pharmaceuticals Ireland<br/>L-Irlanda<br/>Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal<br/>Tel: +372 6610Norge Teva Norway AS<br/>Tlf: +47 66775<br/>TEVA HELLAS . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH<br/>Tel: +43 1970Espa a Teva Pharma, S.L.U.<br/>Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o.<br/>Tel: +48 223459France Teva Sant<br/>T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda.<br/>Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland<br/>Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o.<br/>Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o.<br/>Tel: +421 257267Italia Teva Italia S.r.l.<br/>Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805<br/>TEVA HELLAS . .</p><p>: +30 2118805Sverige Teva Sweden AB<br/>Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij<br/>Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in {month YYYY}.</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp684d3ac7eb172f49f26955be7ae4a00d"/>
<resource>
<MedicinalProductDefinition>
<id value="mp684d3ac7eb172f49f26955be7ae4a00d"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp684d3ac7eb172f49f26955be7ae4a00d"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp684d3ac7eb172f49f26955be7ae4a00d</b></p><a name="mp684d3ac7eb172f49f26955be7ae4a00d"> </a><a name="hcmp684d3ac7eb172f49f26955be7ae4a00d"> </a><a name="mp684d3ac7eb172f49f26955be7ae4a00d-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/19/1358/001 – 1 pre-filled syringe</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: AJOVY 225 mg solution for injection in pre-filled syringe</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/19/1358/001 – 1 pre-filled syringe"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="AJOVY 225 mg solution for injection in pre-filled syringe"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
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.
