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-dac9f5296bbae6c42cca031529e9fd3c"/>
<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-dac9f5296bbae6c42cca031529e9fd3c"/>
<resource>
<Composition>
<id value="composition-en-dac9f5296bbae6c42cca031529e9fd3c"/>
<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-dac9f5296bbae6c42cca031529e9fd3c"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-dac9f5296bbae6c42cca031529e9fd3c</b></p><a name="composition-en-dac9f5296bbae6c42cca031529e9fd3c"> </a><a name="hccomposition-en-dac9f5296bbae6c42cca031529e9fd3c"> </a><a name="composition-en-dac9f5296bbae6c42cca031529e9fd3c-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/1/15/1046/001</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 - elocta</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/1/15/1046/001"/>
</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/mpdac9f5296bbae6c42cca031529e9fd3c"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - elocta"/>
<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 ELOCTA is and what it is used for</li><li>What you need to know before you use ELOCTA</li><li>How to use ELOCTA</li><li>Possible side effects</li><li>How to store ELOCTA</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What elocta 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 elocta is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein. Factor VIII is a protein produced naturally in the body and is necessary for the blood to form clots and stop bleeding.</p><p>ELOCTA is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia A (inherited bleeding disorder caused by factor VIII deficiency).</p><p>ELOCTA is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.</p><p>How ELOCTA works In patients with haemophilia A, factor VIII is missing or not working properly. ELOCTA is used to replace the missing or deficient factor VIII. ELOCTA increases factor VIII level in the blood and temporarily corrects the bleeding tendency.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take elocta"/>
<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 elocta"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use ELOCTA:</p><ul><li>if you are allergic to efmoroctocog alfa or any other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse before using ELOCTA.</p><ul><li><p>There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ELOCTA. Signs of allergic reactions may include generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor.</p></li><li><p>The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If your or your child s bleeding is not being controlled with ELOCTA, tell your doctor immediately.</p></li></ul><p>Cardiovascular events If you have heart disease or are at risk for heart disease, take special care when using factor VIII medicines and talk to your doctor.</p><p>Catheter-related complications If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.</p><p>Documentation It is strongly recommended that every time ELOCTA is given, the name and batch number of the product are recorded.</p><p>Other medicines and ELOCTA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.</p><p>Pregnancy and breast-feeding<br/>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>Driving and using machines<br/>No effects on ability to drive or use of machines have been observed.</p><p>ELOCTA contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free . However, depending on your body weight and dose, you could receive more than one vial. This should be taken into consideration if you are on a controlled sodium diet.</p></div>
</text>
</section>
<section>
<title value="3. How to take elocta"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take elocta"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Treatment with ELOCTA will be started by a doctor who is experienced in the care of patients with haemophilia. Always use this medicine exactly as your doctor has told you (see Instructions for preparation and administration). Check with your doctor, pharmacist or nurse if you are not sure.</p><p>ELOCTA is given as an injection into a vein. Your doctor will calculate the dose of ELOCTA (in International Units or IU ) depending on your individual needs for factor VIII replacement therapy and on whether it is used for prevention or treatment of bleeding. Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive.</p><p>How often you need an injection will depend on how well ELOCTA is working for you. Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels in your blood.</p><p>Treatment of bleeding<br/>The dose of ELOCTA is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.</p><p>Prevention of bleeding The usual dose of ELOCTA is 50 IU per kg of body weight, given every 3 to 5 days. The dose may be adjusted by your doctor in the range of 25 to 65 IU per kg of body weight. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.</p><p>Use in children and adolescents ELOCTA can be used in children and adolescents of all ages. In children below the age of 12, higher doses or more frequent injections may be needed.</p><p>If you use more ELOCTA than you should Tell your doctor as soon as possible. You should always use ELOCTA exactly as your doctor has told you, check with your doctor, pharmacist or nurse if you are not sure.</p><p>If you forget to use ELOCTA Do not take a double dose to make up for a forgotten dose. Take your dose as soon as you remember and then resume your normal dosing schedule. If you are not sure what to do, ask your doctor or pharmacist.</p><p>If you stop using ELOCTA Do not stop using ELOCTA without consulting your doctor. If you stop using ELOCTA you may no longer be protected against bleeding or a current bleed may not stop.</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>If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately. You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, low blood pressure, general feeling of being unwell, nausea, restlessness and fast heartbeat, feeling dizzy or loss of consciousness.</p><p>For children previously untreated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however, patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens the medicines may stop working properly and you may experience persistent bleeding. If this happens, you should contact your doctor immediately.</p><p>The following side effects may occur with this medicine.</p><p>Uncommon side effects (may affect up to 1 in 100 people) Headache, dizziness, taste alteration, slow heartbeat, high blood pressure, hot flushes, vascular pain after injection, cough, lower abdominal pain, rash, papular rash, device-related thrombosis, joint swelling, muscle pain, back pain, joint pain, general discomfort, chest pain, feeling cold, feeling hot and low blood pressure.</p><p>Reporting of side effects<br/>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 elocta"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store elocta"/>
</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 the vial label after EXP . The expiry date refers to the last day of that month. Do not use this medicine if it has been stored at room temperature for longer than 6 months.</p><p>Store in a refrigerator (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light.</p><p>Alternatively, ELOCTA may be stored at room temperature (up to 30 C) for a single period not exceeding 6 months. Record on the carton the date that ELOCTA is removed from the refrigerator and set at room temperature. After storage at room temperature, the product must not be put back in the refrigerator.</p><p>Once you have prepared ELOCTA it should be used right away. If you cannot use the prepared ELOCTA solution immediately, it should be used within 6 hours. Do not refrigerate the prepared solution. Protect the prepared solution from direct sunlight.</p><p>The prepared solution will be clear to slightly opalescent and colourless. Do not use this medicine if you notice that it is cloudy or contains visible particles.</p><p>Discard any unused solution appropriately. 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 ELOCTA contains</p><ul><li>The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein). Each vial of ELOCTA contains nominally 250, 500, 750, 1000, 1500, 2000, 3000 or 4000 IU efmoroctocog alfa.</li><li>The other ingredients are sucrose, sodium chloride, histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections. If you are on a controlled sodium diet, see section 2. What ELOCTA looks like and contents of the pack</li></ul><p>ELOCTA is provided as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The solvent provided for preparation of the solution to inject, is a clear, colourless solution. After preparation, the solution to inject is clear to slightly opalescent and colourless.</p><p>Each pack of ELOCTA contains 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad.</p><p>Marketing Authorisation Holder and Manufacturer Swedish Orphan Biovitrum AB (publ)<br/>SE-112 76 Stockholm Sweden</p><p>This leaflet was last revised in</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/mpdac9f5296bbae6c42cca031529e9fd3c"/>
<resource>
<MedicinalProductDefinition>
<id value="mpdac9f5296bbae6c42cca031529e9fd3c"/>
<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_mpdac9f5296bbae6c42cca031529e9fd3c"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpdac9f5296bbae6c42cca031529e9fd3c</b></p><a name="mpdac9f5296bbae6c42cca031529e9fd3c"> </a><a name="hcmpdac9f5296bbae6c42cca031529e9fd3c"> </a><a name="mpdac9f5296bbae6c42cca031529e9fd3c-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/15/1046/001</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>: ELOCTA 250 IU powder and solvent for solution for injection</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/1/15/1046/001"/>
</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="ELOCTA 250 IU powder and solvent for solution for injection"/>
<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.
