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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What NUBEQA is and what it is used for</li><li>What you need to know before you take NUBEQA</li><li>How to take NUBEQA</li><li>Possible side effects</li><li>How to store NUBEQA</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What nubeqa is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>NUBEQA contains the active substance darolutamide.<br/>It is used to treat adult men with prostate cancer that:</p><ul><li>has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (also called non-metastatic castration-resistant prostate cancer)</li><li>has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (also called metastatic hormone-sensitive prostate cancer).</li></ul><p>How NUBEQA works NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. By blocking these hormones, darolutamide stops prostate cancer cells from growing and dividing.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take NUBEQA if</p><ul><li>you are allergic to darolutamide or any of the other ingredients of this medicine (listed in section 6)</li><li>you are a woman who is or may become pregnant.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before taking NUBEQA if</p><ul><li>you have problems with your kidneys</li><li>you have problems with your liver</li><li>you have any heart conditions including heart rhythm problems or if you are using medicines for these conditions</li><li>you had a surgery to treat blood vessel conditions.</li></ul><p>Taking this medicine may affect your liver tests. If your blood tests show abnormal results of your liver function, your doctor may decide to stop treatment permanently.</p><p>Children and adolescents This medicine is not for use in children and adolescents under 18 years. Prostate cancer does not occur in this age group.</p><p>Other medicines and NUBEQA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>The following medicines may influence the effect of NUBEQA, or NUBEQA may influence the effect of these medicines to treat:</p><ul><li>bacterial infections, such as rifampicin</li><li>epilepsy, such as carbamazepine, phenobarbital, phenytoin</li><li>symptoms of slightly low mood and mild anxiety: St. John's wort (a herbal medicine)</li><li>high cholesterol, such as rosuvastatin, fluvastatin, atorvastatin, pitavastatin</li><li>severe joint inflammation, severe cases of the skin disease psoriasis, and cancers: methotrexate</li><li>inflammatory bowel diseases: sulfasalazine</li></ul><p>Your doctor may therefore change the dose of the medicines that you are taking.</p><p>Pregnancy, breast-feeding and fertility NUBEQA is not for use in women. This medicine could possibly have an effect on male fertility. Follow these advices during and for 1 week after stopping:</p><ul><li>use a highly effective method of contraception to prevent pregnancy, if you are having sex with a woman who can become pregnant.</li><li>use a condom to protect the unborn baby, if you are having sex with a pregnant woman.</li></ul><p>Driving and using machines This medicine is unlikely to affect your ability to drive and use machines.</p><p>NUBEQA 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.</p></div>"
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"div" : "<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 2 tablets 2 times daily</p><p>Your doctor may reduce your dose to 1 tablet 2 times daily, if you have problems with your liver or kidneys. Method of use Swallow the tablets whole, take them with food and a glass of water.</p><p>Your doctor may also prescribe other medicines while you are taking NUBEQA.</p><p>If you take more NUBEQA than you should Continue the treatment with the next dose as scheduled.</p><p>If you forget to take NUBEQA Take your missed dose as soon as you remember before the next scheduled dose. Do not take a double dose to make up for 1 or more forgotten tablets.</p><p>If you stop taking NUBEQA Do not stop taking this medicine unless your doctor tells you to.</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" : "<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 of NUBEQA occur with the following frequencies:</p><p>In patients with non-metastatic castration-resistant prostate cancer Very common side effects (may affect more than 1 in 10 people):</p><ul><li>tiredness</li><li>blood tests showing reduced number of a white blood cell type called neutrophils</li><li>blood tests showing increased levels of substances produced by the liver: bilirubin, aspartate transaminase</li></ul><p>Common side effects (may affect up to 1 in 10 people):</p><ul><li>blockage of the arteries in the heart</li><li>heart failure</li><li>rash</li><li>pain in arms and legs</li><li>pain in muscles and bones</li><li>broken bones</li></ul><p>In patients with metastatic hormone-sensitive prostate cancer Very common side effects (may affect more than 1 in 10 people):</p><ul><li>high blood pressure</li><li>rash</li><li>blood tests showing reduced number of a white blood cell type called neutrophils</li><li>blood tests showing increased levels of substances produced by the liver: bilirubin, alanine transaminase and aspartate transaminase</li></ul><p>Common side effects (may affect up to 1 in 10 people):</p><ul><li>broken bones</li><li>breast enlargement in men</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" : "<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 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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What NUBEQA contains The active substance is darolutamide. Each film-coated tablet contains 300 mg of darolutamide. The other ingredients are:</p><ul><li>calcium hydrogen phosphate (E 341)</li><li>croscarmellose sodium</li><li>hypromellose</li><li>lactose monohydrate</li><li>macrogol (E 1521)</li><li>magnesium stearate (E 470b)</li><li>povidone (E 1201)</li><li>titanium dioxide (E 171)</li></ul><p>See NUBEQA contains lactose in section 2 for more information.</p><p>What NUBEQA looks like and contents of the pack The film-coated tablets (tablets) are white to off-white, oval with a length of 16 mm and a width of 8 mm. They are marked with 300 on one side, and BAYER on the other side.</p><p>Each carton contains:</p><ul><li>96 film-coated tablets consisting of 6 blisters or</li><li>112 film-coated tablets consisting of 7 blisters</li></ul><p>Each blister contains 16 film-coated tablets.</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany</p><p>Manufacturer Orion Corporation, Orion Pharma 24100 Salo Finland 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)2-5356Lietuva 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 24 11 18<br/>Bayer<br/>: +30 210-618 75 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 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 s.r.l. Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 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 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>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.
