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-e904990c0daca9f90faf79e88bc809b4"/>
<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-e904990c0daca9f90faf79e88bc809b4"/>
<resource>
<Composition>
<id value="composition-en-e904990c0daca9f90faf79e88bc809b4"/>
<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-e904990c0daca9f90faf79e88bc809b4"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-e904990c0daca9f90faf79e88bc809b4</b></p><a name="composition-en-e904990c0daca9f90faf79e88bc809b4"> </a><a name="hccomposition-en-e904990c0daca9f90faf79e88bc809b4"> </a><a name="composition-en-e904990c0daca9f90faf79e88bc809b4-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/1/21/1544/001</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 - orladeyo</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/1/21/1544/001"/>
</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/mpe904990c0daca9f90faf79e88bc809b4"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - orladeyo"/>
<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 Orladeyo is and what it is used for</li><li>What you need to know before you take Orladeyo</li><li>How to take Orladeyo</li><li>Possible side effects</li><li>How to store Orladeyo</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What orladeyo 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 orladeyo is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Orladeyo is a medicine that contains the active substance berotralstat. It is used to prevent angioedema attacks in adults, and adolescents aged from 12 years with hereditary angioedema.</p><p>What hereditary angioedema is</p><p>Hereditary angioedema is a condition that often runs in families. It can limit your daily activity by causing attacks of swelling and pain in different parts of your body including:</p><ul><li>hands and feet</li><li>face, eyelids, lips or tongue</li><li>voice-box (larynx), which may make breathing difficult</li><li>genitals</li><li>stomach and intestines</li></ul><p>How Orladeyo works</p><p>In hereditary angioedema your blood does not have enough of a protein called C1 inhibitor, or the protein does not work properly. This leads to too much of the enzyme plasma kallikrein, which in turn increases the levels of bradykinin in your bloodstream. Too much bradykinin leads to symptoms of hereditary angioedema. Berotralstat, the active substance in Orladeyo, blocks the activity of plasma kallikrein and so reduces bradykinin. This prevents the swelling and pain that hereditary angioedema can cause.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take orladeyo"/>
<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 orladeyo"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Orladeyo</p><ul><li>if you are allergic to berotralstat or any of the other ingredients of this medicine (listed in section 6)</li></ul><p>Warnings and precautions</p><p>Talk to your doctor or pharmacist before taking Orladeyo if you:</p><ul><li>have moderate or severely reduced liver function which can increase blood levels of berotralstat</li><li>have severely reduced kidney function</li><li>are at risk for a certain heartbeat abnormality, known as QT prolongation</li></ul><p>Treat a hereditary angioedema attack with your regular rescue medicine without taking additional doses of Orladeyo. It is not known if Orladeyo works for immediate treatment of attacks of hereditary angioedema.</p><p>Children and adolescents</p><p>Orladeyo is not recommended in children under 12 years. This is because it has not been studied in this age group. Orladeyo has not been studied in adolescents weighing less than 40 kg.</p><p>Other medicines and Orladeyo</p><p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Particularly, tell your doctor before taking Orladeyo if you are using:</p><ul><li>thioridazine or pimozide, medicines to treat mental disorders</li><li>amlodipine, a medicine to treat high blood pressure or a type of chest pain called angina</li><li>ciclosporin, a medicine to suppress the immune system, treat severe skin diseases and severe eye or joint inflammation</li><li>dabigatran, a medicine to prevent blood clotting</li><li>rifampicin: a medicine to treat tuberculosis or certain other infections</li><li>desipramine, St. John s wort and other medicines to treat depression called tricyclic antidepressants</li><li>dextromethorphan, a cough-relieving medicine</li><li>digoxin, a medicine to treat heart problems and irregular heartbeat</li><li>fentanyl, a strong painkiller</li><li>midazolam, a medicine to treat sleeping disorders and for anaesthesia</li><li>tolbutamide, a medicine to reduce blood sugar</li><li>oral contraceptives, medicines used for birth control</li></ul><p>Pregnancy and breast-feeding</p><p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.</p><p>There is limited information on the use of Orladeyo during pregnancy and breast-feeding. As a precaution, it is preferable to avoid the use of Orladeyo during pregnancy and breast-feeding. Your doctor will discuss with you the risks and benefits of taking this medicine.</p><p>Women of childbearing potential must use effective contraception during treatment and for at least 1 month following the last dose. Orladeyo is not recommended in women of childbearing potential not using contraception.</p><p>Driving and using machines</p><p>Orladeyo has no or negligible influence on the ability to drive and use machines.</p></div>
</text>
</section>
<section>
<title value="3. How to take orladeyo"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take orladeyo"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>The recommended dose is The recommended dose for adults and adolescents from 12 years weighing 40 kg is one capsule once daily.</p><p>Orladeyo is not recommended in patients with moderate or severely reduced liver function. As a precautionary measure, this also applies to patients on dialysis.</p><p>Method of administration</p><p>Take the capsule with food and one glass of water at the same time each day. This can be at any time of the day.</p><p>If you take more Orladeyo than you should</p><p>Contact your doctor immediately if this occurs.</p><p>If you forget to take Orladeyo</p><p>Do not take a double dose to make up for a forgotten capsule. Take a missed dose as soon as you remember; however, do not take more than one dose per day.</p><p>If you stop taking Orladeyo</p><p>It is important to take this medicine on a regular basis and for as long as your doctor prescribes it. Do not stop taking it without approval from your doctor.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</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>Side effects can occur with the following frequencies: Very common, may affect more than 1 in 10 people</p><ul><li>headache</li><li>stomach pain, including abdominal (belly) discomfort, abdominal tenderness</li><li>diarrhoea and frequent bowel movements</li></ul><p>Common, may affect up to 1 in 10 people</p><ul><li>vomiting</li><li>heartburn</li><li>wind</li><li>blood tests showing increased levels of liver enzymes called ALT and AST</li><li>rash</li></ul><p>Reporting of side effects</p><p>If you get any side effects, talk to your doctor or pharmacist. 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 orladeyo"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store orladeyo"/>
</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 carton and blister 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/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 Orladeyo contains</p><ul><li>The active substance is berotralstat. Each capsule contains 150 mg berotralstat (as dihydrochloride).</li><li>The other ingredients are:</li></ul><ul><li>starch, pregelatinised, crospovidone (type A), silica, colloidal anhydrous, magnesium stearate, gelatin, titanium dioxide (E 171)</li><li>colourants: indigo carmine (E 132), black iron oxide (E 172), red iron oxide (E 172)</li><li>edible printing ink: black iron oxide (E 172), potassium hydroxide, shellac, propylene glycol (E 1520)</li></ul><p>What Orladeyo looks like and contents of the pack</p><p>Orladeyo capsules have a white opaque body imprinted with 150 and light blue opaque cap imprinted with BCX (19.4 mm 6.9 mm). They are packed in plastic/aluminium blisters in a carton with 7 capsules per blister.</p><p>Pack size: 28 or 98 hard capsules</p><p>Marketing Authorisation Holder and Manufacturer</p><ul><li><p>Marketing Authorisation Holder BioCryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HWIreland</p></li><li><p>Manufacturer Millmount Healthcare Limited<br/>Block-7, City North Business Campus,<br/>Stamullen,<br/>Co. Meath, K32 YDIreland</p></li></ul><p>This leaflet was last revised in</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/mpe904990c0daca9f90faf79e88bc809b4"/>
<resource>
<MedicinalProductDefinition>
<id value="mpe904990c0daca9f90faf79e88bc809b4"/>
<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_mpe904990c0daca9f90faf79e88bc809b4"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpe904990c0daca9f90faf79e88bc809b4</b></p><a name="mpe904990c0daca9f90faf79e88bc809b4"> </a><a name="hcmpe904990c0daca9f90faf79e88bc809b4"> </a><a name="mpe904990c0daca9f90faf79e88bc809b4-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/21/1544/001</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>: Orladeyo 150 mg hard capsules</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/1/21/1544/001"/>
</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="Orladeyo 150 mg hard capsules"/>
<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.
