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 Verquvo is and what it is used for</li><li>What you need to know before you take Verquvo</li><li>How to take Verquvo</li><li>Possible side effects</li><li>How to store Verquvo</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>Verquvo contains the active substance vericiguat, which is a type of heart medicine called soluble guanylate cyclase stimulator.</p><p>Verquvo is used to treat adults with long-term heart failure who recently have had an increase in heart failure symptoms. Therefore, you may have gone to hospital and/or received a medicine (diuretic) given in a vein to help you pass more urine than usual.</p><p>Heart failure is when your heart is weak and cannot pump enough blood to your body. Some common symptoms of heart failure are shortness of breath, tiredness, or swelling caused by a build-up of fluid.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Verquvo if you are</p><ul><li>allergic to vericiguat or any of the other ingredients of this medicine (listed in section 6),</li><li>taking any medicine that contains another soluble guanylate cyclase stimulator, e.g. riociguat used to treat high blood pressure in lungs. If any of the above applies to you, talk to your doctor first and do not take this medicine.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before taking Verquvo if you have</p><ul><li>low blood pressure with symptoms like dizziness or light-headedness,</li><li>severe kidney problems or are on dialysis,</li><li>severe liver problems.</li></ul><p>Children and adolescents Do not give this medicine to children and adolescents aged under 18 years because it has not been studied yet in this age group.</p><p>Other medicines and Verquvo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular medicines that</p><ul><li>belong to the group of soluble guanylate cyclase stimulators (e.g. riociguat). Do not take Verquvo when taking these medicines. See Do not take Verquvo .</li><li>treat high blood pressure in the lungs, or medicines to achieve or maintain an erection, called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). The use of these medicines is not recommended when taking Verquvo.</li><li>treat heart disease including chest pain, called nitrates (e.g. isosorbide mononitrate).</li></ul><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 or pharmacist for advice before taking this medicine.</p><p>Pregnancy Verquvo should not be used during pregnancy, as it is not known if it harms the unborn baby. If there is a chance that you could become pregnant, talk to your doctor about reliable forms of contraception.</p><p>Breast-feeding It is not known if Verquvo passes into your breast milk and could harm your baby. Your doctor will decide with you whether breast-feeding or Verquvo therapy should be stopped.</p><p>Driving and using machines If you feel dizzy while taking this medicine, do not drive a vehicle, cycle or use any machines.</p><p>Verquvo contains lactose and sodium This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.</p><p>The recommended starting dose is 1 tablet of 2.5 mg once daily. Your doctor will then adjust the dose depending on how well the treatment is tolerated. Typically, your doctor will increase the dose after about 2 weeks to 1 tablet of 5 mg once daily and after about another 2 weeks up to the maximum target dose of 1 tablet of 10 mg once daily.</p><p>If you have low blood pressure while taking Verquvo, this can make you feel dizzy and light-headed and your doctor may temporarily reduce your Verquvo dose or interrupt your treatment with Verquvo.</p><p>Take one tablet at the same time each day with food. If you cannot swallow the tablet, you may crush Verquvo and mix it with water. Take this mixture immediately.</p><p>If you take more Verquvo than you should Contact your doctor immediately if you take more Verquvo than you should and you get any side effects listed in section 4. The most likely effect would be a lowering of your blood pressure which can make you feel dizzy and light-headed.</p><p>If you forget to take Verquvo Take the missed tablet as soon as you remember on the same day of the missed dose. Do not take a double dose to make up for a forgotten tablet.</p><p>If you stop taking Verquvo Do not stop taking this medicine without speaking with your doctor first. If you stop taking this medicine, your condition may worsen.</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 possible side effects are:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>low blood pressure (hypotension)</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>low number of red blood cells (anaemia), which can cause pale skin, weakness or breathlessness</li><li>dizziness</li><li>headache</li><li>nausea and vomiting</li><li>indigestion (dyspepsia)</li><li>heartburn (gastro-oesophageal reflux disease)</li></ul><p>Reporting of side effects 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>
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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 the carton and on each blister or bottle 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>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Verquvo contains</p><ul><li>The active substance is vericiguat. Each film-coated tablet contains 2.5 mg, 5 mg or 10 mg vericiguat.</li><li>The other ingredients are: Tablet core: Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate (see section 2 Verquvo contains lactose and sodium ). Film-coat: Hypromellose 2910, talc, titanium dioxide (E 171), iron oxide red (E 172) (Verquvo 5 mg only), iron oxide yellow (E 172) (Verquvo 10 mg only).</li></ul><p>What Verquvo looks like and contents of the pack Verquvo 2.5 mg film-coated tablets (tablets) are round, biconvex and white with a diameter of 7 mm, marked with 2.5 on one side and VC on the other side. Verquvo 5 mg film-coated tablets (tablets) are round, biconvex and brown-red with a diameter of 7 mm, marked with 5 on one side and VC on the other side. Verquvo 10 mg film-coated tablets (tablets) are round, biconvex and yellow-orange with a diameter of 9 mm, marked with 10 on one side and VC on the other side.</p><p>Verquvo is available</p><ul><li>in blisters in cartons of 14, 28 or 98 film-coated tablets</li><li>in perforated unit dose blisters in cartons of 10 1 or 100 1 film-coated tablets</li><li>in bottles of 100 film-coated tablets</li></ul><p>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 02 4247Luxembourg/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-(0)297-28 06 Eesti 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 8Slovensk 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 3This 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>
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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.
