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" xml:lang="en" lang="en"><a name="Composition_composition-en-2a82ca3c186080c5b1ee752847b09ce0"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-2a82ca3c186080c5b1ee752847b09ce0</b></p><a name="composition-en-2a82ca3c186080c5b1ee752847b09ce0"> </a><a name="hccomposition-en-2a82ca3c186080c5b1ee752847b09ce0"> </a><a name="composition-en-2a82ca3c186080c5b1ee752847b09ce0-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/1/18/1324/001 – 1 x (Jivi 250 IU)</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 - jivi</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>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Jivi is and what it is used for</li><li>What you need to know before you use Jivi</li><li>How to use Jivi</li><li>Possible side effects</li><li>How to store Jivi</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>Jivi contains the active substance damoctocog alfa pegol. It is produced by recombinant technology without addition of any human- or animal-derived components in the manufacturing process. Factor VIII is a protein naturally found in the blood that helps to clot it. The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its action in the body.</p><p>Jivi is used to treat and prevent bleeding in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency). It is not for use in children younger than 12 years of age.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Jivi if you are</p><ul><li>allergic to damoctocog alfa pegol or any of the other ingredients of this medicine (listed in section 6).</li><li>allergic to mouse or hamster proteins.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist if you have</p><ul><li>tightness in the chest, fall in blood pressure (often shown by feeling dizzy when getting up quickly), itchy nettle-rash, wheezing, feeling sick or faint. These may be signs of a rare severe sudden allergic reaction to this medicine. Stop injecting the product immediately and get medical help at once if this occurs.</li><li>bleeding that is not being controlled with your usual dose of this medicine. Speak with your doctor immediately if this occurs. You may have developed antibodies against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG). These make Jivi less effective at preventing and controlling bleeding. Your doctor may carry out tests to confirm this and ensure that your Jivi dose provides adequate factor VIII levels. Your doctor may switch you back to your previous factor VIII treatment, if needed.</li><li>previously developed factor VIII inhibitors to a different product.</li><li>heart disease or you are at risk of heart disease.</li><li>to use a central venous access device for this medicine. You may be at risk of device-related complications where the catheter is inserted including: local infections<br/>bacteria in the blood a blood clot in the blood vessel</li></ul><p>Children Jivi is not for use in children younger than 12 years of age.</p><p>Other medicines and Jivi Jivi is not known to influence or be influenced by other medicines. 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.</p><p>Driving and using machines Jivi has no influence on your ability to drive and use machines.</p><p>Jivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Treatment with Jivi will be started by a doctor who is experienced in the care of patients with haemophilia A. After suitable training patients or carers may be able to give Jivi at home. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose of factor VIII units is measured in International Units (IU).</p><p>Treatment of bleeding To treat a bleed, your doctor will calculate and adjust your dose and how often it should be given, depending on factors such as:</p><ul><li>your weight</li><li>the severity of your haemophilia A</li><li>where the bleeding is and how serious it is</li><li>whether you have inhibitors and how high their level is</li><li>the factor VIII level that is needed.</li></ul><p>Prevention of bleeding To prevent bleeding your doctor will select an appropriate dose and frequency depending on your need:</p><ul><li>45 60 IU per kg body weight every 5 days or</li><li>60 IU per kg body weight every 7 days or</li><li>30 40 IU per kg body weight two times per week.</li></ul><p>Laboratory tests Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels. For major surgery in particular, your blood clotting must be closely monitored.</p><p>Duration of treatment Usually Jivi treatment for haemophilia is needed lifelong.</p><p>How Jivi is given Jivi is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level. The maximum rate is 2.5 mL per minute. Jivi should be used within 3 hours after reconstitution.</p><p>How Jivi is prepared for injection Use only the components (vial adapter, pre-filled syringe containing solvent and venipuncture set) provided with each package of this medicine. Please contact your doctor if these components cannot be used. Do not use if any component of the package is opened or damaged.</p><p>The reconstituted product must be filtered by using the vial adapter before injection to remove any possible particles in the solution.</p><p>This medicine must not be mixed with other injections. Do not use solutions that are cloudy or contain visible particles. Follow the instructions for use given by your doctor and provided at the end of this leaflet.</p><p>If you use more Jivi than you should Tell your doctor if this occurs. No symptoms of overdose have been reported.</p><p>If you forget to use Jivi Inject your next dose immediately and continue at regular intervals as advised by your doctor.<br/>Do not use a double dose to make up for a forgotten dose.</p><p>If you stop using Jivi Do not stop using this medicine without checking with your doctor.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</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>The most serious side effects are allergic reactions or severe allergic reaction. Stop injecting Jivi immediately and speak to your doctor at once if such reactions occur. The following symptoms could be an early warning of these reactions:</p><ul><li>chest tightness/general feeling of being unwell</li><li>burning and stinging at the application site</li><li>nettle rash, flushing</li><li>a reduction in blood pressure, which may make you feel faint upon standing</li><li>feeling sick (nausea)</li></ul><p>For patients who have received previous treatment with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients). If this happens your medicine 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>Very common (may affect more than 1 in 10 people):</p><ul><li>headache</li></ul><p>Common (may affect up to 1 in 10 people):</p><ul><li>stomach pain</li><li>nausea, vomiting</li><li>fever</li><li>allergic reactions (may present as hives, generalized urticaria, tightness of the chest, wheezing, shortness of breath, low blood pressure, for early symptoms see above)</li><li>local reactions at the injection site such as bleeding under the skin, intense itching, swelling, burning sensation, temporary redness</li><li>dizziness</li><li>trouble falling asleep</li><li>cough</li><li>rash, skin reddening</li></ul><p>Uncommon (may affect up to 1 in 100 people):</p><ul><li>FVIII inhibition</li><li>taste disturbance</li><li>flushing</li><li>itching</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor. 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 the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on labels and cartons. 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 vial and the pre-filled syringe in the outer carton in order to protect from light.</p><p>This medicine may be stored at room temperature (up to 25 C) for up to 6 months when you keep it in its outer carton. If you store it at room temperature it expires after 6 months, or the expiry date if this is earlier. The new expiry date must be noted on the outer carton when the medicine is removed from the refrigerator.</p><p>Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 3 hours.</p><p>Do not use this medicine if you notice any particles or the solution is cloudy.</p><p>This medicine is for single use only. Any unused solution must be discarded.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or physician how to throw away medicines 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 Jivi contains</p><ul><li><p>The active substance is PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol). Each vial of Jivi contains nominally 250 or 500 or 1 000 or 2 000 or 3 000 IU damoctocog alfa pegol. After reconstitution with the supplied solvent (sterile water for injection), the prepared solutions have the following concentration: Strength Concentration after reconstitution approximately 250 IU (100 IU / mL) 500 IU (200 IU / mL) 1 000 IU (400 IU / mL) 2 000 IU (800 IU / mL) 3 000 IU (1 200 IU / mL)</p></li><li><p>The other ingredients are sucrose, histidine, glycine, sodium chloride (see section 2 Jivi contains sodium ), calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.</p></li></ul><p>What Jivi looks like and contents of the pack</p><p>Jivi is provided as a powder and solvent for solution for injection. The powder is dry, and white to slightly yellow. The solvent is a clear liquid. After reconstitution the solution is clear.</p><p>Each single pack of Jivi contains:</p><ul><li>a glass vial with powder</li><li>a pre-filled syringe with solvent</li><li>a separate plunger rod</li><li>a vial adapter</li><li>a venipuncture set</li></ul><p>Jivi is available in pack sizes of:</p><p>1 single pack</p><p>1 multipack with 30 single packs Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany</p><p>Manufacturer Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +37 05 23 36</p><p>T .: +359-(0)2-424 72 Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel:+36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-23 799 1Eesti Bayer O<br/>Tel: +372 655 8Norge Bayer AS Tlf: +47 23 13 05<br/>Bayer<br/>: +30-210-61 87 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0</p><p>Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer SRL Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 sland Icepharma hf. S mi: +354 540 8 Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 8 1</p><p>Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785<br/>NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3 This leaflet was last revised in</p><p>Detailed information on this medicine is available on the website of the European Medicines Agency</p></div>
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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.
