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 Pifeltro is and what it is used for</li><li>What you need to know before you take Pifeltro</li><li>How to take Pifeltro</li><li>Possible side effects</li><li>How to store Pifeltro</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What pifeltro is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Pifeltro is Pifeltro is used to treat HIV ( human immunodeficiency virus ) infection. It belongs to a group of medicines called antiretroviral medicines . Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI). What Pifeltro is used for Pifeltro is used to treat HIV infection in adults, and adolescents aged 12 years and older weighing at least 35 kg. HIV is the virus that causes AIDS ( acquired immune deficiency syndrome ). You should not take Pifeltro if your doctor has told you that the virus causing your infection is resistant to doravirine. Pifeltro must be used in combination with other medicines for HIV. How Pifeltro works When used with other medicines, Pifeltro works by preventing HIV from making more viruses in your body. This will help by:</p><ul><li>reducing the amount of HIV in your blood (this is called your viral load )</li><li>increasing the number of white blood cells called CD4+ T . This can make your immune system stronger. This may reduce your risk of early death or catching infections because your immune system is weak.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Pifeltro</p><ul><li>if you are allergic to doravirine or any of the other ingredients of this medicine listed in section 6. * if you are taking the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizures) rifampicin, rifapentine (medicines for tuberculosis) St. John s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it mitotane (a medicine to treat cancer) enzalutamide (a medicine to treat prostate cancer) lumacaftor (a medicine to treat cystic fibrosis) Do not take Pifeltro if the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Pifeltro. See also Other Medicines and Pifeltro section. Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Pifeltro. Immune reactivation syndrome This can happen when you start taking any HIV medicine, including this medicine. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV medicine. Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. Children and adolescents Do not give this medicine to children aged less than 12 years or weighing less than 35 kg. The use of Pifeltro in children aged less than 12 years or weighing less than 35 kg has not yet been studied. Other medicines and Pifeltro Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines. This is because other medicines may affect how Pifeltro works, and Pifeltro might affect the way some other medicines work. There are some medicines you must not take with Pifeltro. See list under Do not take Pifeltro section. Talk to your doctor before taking the following medicines with Pifeltro, as your doctor may need to change the dose of your medicines:</li><li>bosentan (a medicine to treat lung disease)</li><li>dabrafenib (a medicine to treat skin cancer)</li><li>lesinurad (a medicine to treat gout)</li><li>modafinil (a medicine to treat excessive sleepiness)</li><li>nafcillin (a medicine to treat some bacterial infections)</li><li>rifabutin (a medicine to treat some bacterial infections such as tuberculosis)</li><li>telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)</li><li>thioridazine (a medicine to treat psychiatric conditions such as schizophrenia) If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart). Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Pifeltro:</li><li>sirolimus (a medicine used to control your body s immune response after a transplant)</li><li>tacrolimus (a medicine used to control your body s immune response after a transplant) Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Pifeltro. It is preferable to avoid the use of this medicine during pregnancy. This is because it has not been studied in pregnancy and it is not known if it will harm your baby while you are pregnant. Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible. Driving and using machines Use caution when driving or riding a bicycle, or operating machines if you feel dizzy, tired, or sleepy after taking this medicine. Pifeltro tablets contain lactose If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure. This medicine must be used in combination with other medicines for HIV. How much to take The recommended dose is 1 tablet once a day. If you take certain medicines, your doctor may need to change the amount of doravirine you take. See Other medicines and Pifeltro section for a list of medicines. Taking this medicine</p><ul><li>Swallow the tablet whole (do not crush or chew).</li><li>This medicine can be taken with food or between meals. If you take more Pifeltro than you should Do not take more than the recommended dose. If you accidentally take more, contact your doctor. If you forget to take Pifeltro</li><li>It is important that you do not miss or skip doses of this medicine.</li><li>If you forget to take a dose, take it as soon as you remember. But if your next dose is due within 12 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.</li><li>Do not take a double dose to make up for a missed dose.</li><li>If you are not sure what to do, call your doctor or pharmacist. If you stop taking Pifeltro Do not run out of this medicine. Refill your prescription or talk to your doctor before it is all gone. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.</li></ul></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. Do not stop taking this medicine without first talking to your doctor. Common: may affect up to 1 in 10 people:</p><ul><li>abnormal dreams, difficulty in sleeping (insomnia)</li><li>headache, dizziness, sleepiness</li><li>feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)</li><li>rash</li><li>feeling tired Blood tests may also show:</li><li>increased levels of liver enzymes (ALT) Uncommon: may affect up to 1 in 100 people:</li><li>nightmares, depression, anxiety, irritability, confusion, suicidal thoughts</li><li>trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality sleep</li><li>high blood pressure</li><li>constipation, stomach discomfort, swollen or bloated stomach (abdominal distension), indigestion, soft stools, stomach spasms</li><li>itchiness</li><li>muscle pain, joint pain</li><li>feeling weak, general feeling of being unwell Blood tests may also show:</li><li>decreased levels of phosphate</li><li>increased levels of liver enzymes (AST)</li><li>increased levels of lipase</li><li>increased levels of amylase</li><li>decreased levels of haemoglobin Rare: may affect up to 1 in 1 000 people:</li><li>aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking</li><li>difficulty breathing, enlarged tonsils</li><li>feeling of incomplete defecation</li><li>inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face</li><li>kidney damage, kidney problems, kidney stones</li><li>pain in the chest, feeling cold, pain, thirst Blood tests may also show:</li><li>decreased levels of magnesium</li><li>increased levels of creatine phosphokinase Reporting of side effects 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.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Keep this medicine out of the sight and reach of children.</li><li>Do not use this medicine after the expiry date which is stated on the bottle after EXP. This medicine should be used within 35 days after first opening of the bottle.</li><li>The bottle contains a desiccant protecting the tablets from moisture. Keep the desiccant inside the bottle and do not throw away until you have finished taking all of the medicine.</li><li>Keep the bottle tightly closed in order to protect from moisture.</li><li>This medicinal product does not require any special temperature storage conditions.</li><li>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.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Pifeltro contains</p><ul><li>The active substance is doravirine 100 mg.</li><li>The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal anhydrous E551. The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171; and triacetin E1518. What Pifeltro looks like and contents of the pack Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side. The following pack sizes are available:</li><li>1 bottle with 30 film-coated tablets</li><li>90 film-coated tablets (3 bottles of 30 film-coated tablets) Not all pack sizes may be available in your country. Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> Lietuva UAB Merck Sharp & Dohme Tel. + 370 5 278 02 <a href=\"mailto:msd_lietuva@merck.com\">msd_lietuva@merck.com</a></li></ul><p>.: +359 2 819 <a href=\"mailto:3info-msdbg@merck.com\">3info-msdbg@merck.com</a> Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> esk republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 <a href=\"mailto:dpoc_czechslovak@merck.com\">dpoc_czechslovak@merck.com</a> Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 <a href=\"mailto:5hungary_msd@merck.com\">5hungary_msd@merck.com</a> Danmark MSD Danmark ApS Tlf: + 45 4482 <a href=\"mailto:4dkmail@merck.com\">4dkmail@merck.com</a> Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) <a href=\"mailto:malta_info@merck.com\">malta_info@merck.com</a> Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href=\"mailto:e-mail@msd.de\">e-mail@msd.de</a> Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999(+31 23 5153153) <a href=\"mailto:medicalinfo.nl@merck.com\">medicalinfo.nl@merck.com</a> Eesti Merck Sharp & Dohme O Tel.: +372 6144 <a href=\"mailto:msdeesti@merck.com\">msdeesti@merck.com</a> Norge MSD (Norge) AS Tlf: +47 32 20 73 <a href=\"mailto:msdnorge@msd.no\">msdnorge@msd.no</a></p><p>MSD . . . . . : +30 210 98 97 <a href=\"mailto:dpoc_greece@merck.com\">dpoc_greece@merck.com</a> sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href=\"mailto:dpoc_austria@merck.com\">dpoc_austria@merck.com</a> Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href=\"mailto:msd_info@merck.com\">msd_info@merck.com</a> Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 <a href=\"mailto:msdpolska@merck.com\">msdpolska@merck.com</a> France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 <a href=\"mailto:4465inform_pt@merck.com\">4465inform_pt@merck.com</a> Hrvatska: Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 <a href=\"mailto:croatia_info@merck.com\">croatia_info@merck.com</a> Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 <a href=\"mailto:msdromania@merck.com\">msdromania@merck.com</a> Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfo_ireland@merck.com\">2998medinfo_ireland@merck.com</a> Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 <a href=\"mailto:msd.slovenia@merck.com\">msd.slovenia@merck.com</a> sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 <a href=\"mailto:58282dpoc_czechslovak@merck.com\">58282dpoc_czechslovak@merck.com</a> Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) <a href=\"mailto:medicalinformation.it@msd.com\">medicalinformation.it@msd.com</a> Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 <a href=\"mailto:info@msd.fi\">info@msd.fi</a></p><p>Merck Sharp & Dohme Cyprus Limited .: 800 00 673 (+357 22866700) <a href=\"mailto:cyprus_info@merck.com\">cyprus_info@merck.com</a> Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 <a href=\"mailto:5700medicinskinfo@merck.com\">5700medicinskinfo@merck.com</a> Latvija SIA Merck Sharp & Dohme Latvija Tel: + 371 <a href=\"mailto:67364msd_lv@merck.com\">67364msd_lv@merck.com</a> United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfoNI@msd.com\">2998medinfoNI@msd.com</a> This leaflet was last revised in {MM/YYYY} Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a> .</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpd9e1f5caf32113b1e6722af1d88782c1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd9e1f5caf32113b1e6722af1d88782c1</b></p><a name=\"mpd9e1f5caf32113b1e6722af1d88782c1\"> </a><a name=\"hcmpd9e1f5caf32113b1e6722af1d88782c1\"> </a><a name=\"mpd9e1f5caf32113b1e6722af1d88782c1-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1332/001</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>: Pifeltro 100 mg film-coated tablets</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>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "EU/1/18/1332/001"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"domain" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-domain",
"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "Pifeltro 100 mg film-coated tablets",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "en"
}
]
}
}
]
}
]
}
}
]
}
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.
