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
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Regkirona is and what it is used for</li><li>What you need to know before you are given Regkirona</li><li>How Regkirona is given to you</li><li>Possible side effects</li><li>How to store Regkirona</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>The active substance of Regkirona is regdanvimab. It is a monoclonal antibody used for the treatment of COVID-19, a disease caused by a virus called SARS-CoV-2. Regkirona is given to adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. This medicine stops the virus from entering human cells by binding to the spike protein of SARS-CoV-2. When it attaches to the spike protein, the interaction between the virus and the cellular receptor is blocked and the ability of the virus to enter the body s cells is reduced. This can help your body to resist the virus infection, and may help to prevent the disease from getting worse.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Regkirona:</p><ul><li>if you are allergic to regdanvimab or any of the other ingredients of this medicine (listed in section 6).<br/>Talk to your doctor or nurse as soon as possible, if this applies to you.</li></ul><p>Warnings and precautions</p><p>Reactions after receiving the medicine<br/>This medicine can cause allergic reactions or other reactions after the medicine is given to you. See also section 4, Possible side effects . Symptoms can include:</p><ul><li><p>Fever</p></li><li><p>Difficulty breathing</p></li><li><p>Shortness of breath, rapid breathing or rapid heartbeat</p></li><li><p>Chills</p></li><li><p>Feeling tired</p></li><li><p>Irregular, rapid or slow heart rate</p></li><li><p>Chest discomfort or pain</p></li><li><p>Weakness</p></li><li><p>Confusion</p></li><li><p>Feeling sick (nausea)</p></li><li><p>Headache</p></li><li><p>Shortness of breath, wheezing</p></li><li><p>Low or high blood pressure</p></li><li><p>Swelling of the face, lips, or throat (angioedema)</p></li><li><p>Rash including nettle rash</p></li><li><p>Itching</p></li><li><p>Muscle aches</p></li><li><p>Feeling faint</p></li><li><p>Dizziness</p></li><li><p>Sweating</p><p>Seek urgent medical advice if you get any of these symptoms.</p></li></ul><p>Children and adolescents This medicine is not to be given to children and adolescents under 18 years of age because there are no data to show that this medicine is safe and works in this age group.</p><p>Other medicines and Regkirona Tell your doctor or nurse about any other medicines you are taking, or have recently taken.</p><p>It is not yet known if this medicine affects other medicines, or if it is affected by them. Your healthcare team will monitor you for signs of medicines affecting each other.</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 for advice before receiving Regkirona. Your doctor will advise you whether the benefits of treatment with Regkirona are greater than any likely risks for you and your baby.</p><p>It is not known whether the ingredients of Regkirona can pass into breast milk. If you are breast-feeding, you must check with your doctor before you receive Regkirona.</p><p>Driving and using machines Regkirona is not expected to have any effect on your ability to drive or use tools or machines.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>This medicine will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 60 minutes.</p><p>The recommended dose is a single dose of 40 mg/kg. This medicine should be given within 7 days of symptom onset.</p><p>This medicine can cause infusion reactions after the medicine is given to you. You will be closely monitored during your treatment and for at least 1 hour after infusion is complete.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</p></div>
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<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>Tell your doctor or nurse if you notice any of the following side effects:</p><ul><li>Uncommon: may affect up to 1 in 100 people</li></ul><ul><li>Allergic reactions due to an infusion (e.g. fever, difficulty breathing, irregular, rapid or slow heart rate, high blood pressure, rash including nettle rash, itching, feeling faint)</li></ul><p>In general, these types of reactions occur within minutes to several hours following completion of the infusion.</p><p>Reporting of side effects If you get any side effects, talk to your doctor 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>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Keep this medicine out of sight and reach of children</p><p>Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.</p><p>Store in a refrigerator (2 C 8 C). Keep the vial in the outer carton in order to protect from light. Do not freeze.</p><p>Do not use this medicine if you notice any particulate matter or discoloration prior to administration.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Regkirona contains</p><ul><li>The active ingredient is called regdanvimab. The vial contains 960 mg of regdanvimab in 16 mL (60 mg/mL).</li><li>The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, L-arginine monohydrochloride and water for injections.</li></ul><p>What Regkirona looks like and contents of the pack This medicine is a clear to opalescent, colourless to pale yellow liquid solution in a glass vial with a rubber stopper and flip-off aluminium seal supplied as a concentrate for solution for infusion.</p><p>Regkirona is available in packs containing 1 vial.</p><p>Marketing Authorisation Holder</p><p>Celltrion Healthcare Hungary Kft.<br/>1062 Budapest<br/>V ci t 1-3. WestEnd Office Building B torony<br/>Hungary</p><p>Manufacturer<br/>NUVISAN GmbH<br/>Wegenerstr. 13,<br/>Neu-Ulm, Bayern, 89GERMANY</p><p>NUVISAN FRANCE SARL 2400 route des Colles,<br/>06410 BIOT,<br/>FRANCE</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Celltrion Healthcare Belgium BVBA T l/Tel: + 32 1528 <a href="mailto:7BEinfo@celltrionhc.com">7BEinfo@celltrionhc.com</a> Lietuva Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony</p><p>Te .: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Luxembourg/Luxemburg Celltrion Healthcare Belgium BVBA T l/Tel: +32 1528 <a href="mailto:7BEinfo@celltrionhc.com">7BEinfo@celltrionhc.com</a> esk republika Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ma arsko Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Magyarorsz g Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Magyarorsz g Tel.: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Danmark Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tlf: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Malta Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a> Deutschland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Nederland Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 <a href="mailto:7NLinfo@celltrionhc.com">7NLinfo@celltrionhc.com</a> Eesti Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungari Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Norge Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungarn Tlf: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>. . : +30 210 8009111 sterreich Astro-Pharma GmbH Tel.: +43 1 97 99 <a href="mailto:office@astropharma.at">office@astropharma.at</a></p><p>Espa a OMFE SA<br/>Carretera Fuencarral-Alcobendas N 6 28Madrid Tel: +34 <a href="mailto:917408lulopezf@cofares.es">917408lulopezf@cofares.es</a> Polska Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony W gry Tel.: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>France CELLTRION HEALTHCARE FRANCE SAS 14 rue Cambac r s 75008 Paris T l: +33 (0)1 71 25 27 <a href="mailto:contact_FR@celltrionhc.com">contact_FR@celltrionhc.com</a> Portugal PharmaKERN Portugal Produtos Farmac uticos, Sociedade Unipessoal, Lda. Tel: +351 214 200 Hrvatska Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Rom nia Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungaria Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Ireland Celltrion Healthcare Ireland Ltd. 26, Arrow Building, Old Belgard Road, Tallaght, Dublin D24 ND70, Ireland Tel: +353-1-223-4Slovenija Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>sland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungverjaland S mi: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Slovensk republika Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ma arsko Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Italia Celltrion Healthcare Italy S.R.L. Tel: +39 0247 927Suomi/Finland Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Unkari Puh/Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Vengrija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a><br/>Sverige Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ungern Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>Latvija Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Ung rija Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>United Kingdom (Northern Ireland) Celltrion Healthcare Hungary Kft. 1062 Budapest V ci t 1-3. WestEnd Office Building B torony Hungary Tel: +36 1 231 <a href="mailto:0healthcare.hu@celltrionhc.com">0healthcare.hu@celltrionhc.com</a></p><p>This leaflet was last revised in {MM/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>
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<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.
