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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-e8001a6516c891d8a1ff3a481f290741"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-e8001a6516c891d8a1ff3a481f290741"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-e8001a6516c891d8a1ff3a481f290741> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mpe8001a6516c891d8a1ff3a481f290741"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mpe8001a6516c891d8a1ff3a481f290741> ) ] ) . # <Composition/composition-en-e8001a6516c891d8a1ff3a481f290741> a fhir:Composition ; fhir:id [ fhir:v "composition-en-e8001a6516c891d8a1ff3a481f290741"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-e8001a6516c891d8a1ff3a481f290741\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-e8001a6516c891d8a1ff3a481f290741</b></p><a name=\"composition-en-e8001a6516c891d8a1ff3a481f290741\"> </a><a name=\"hccomposition-en-e8001a6516c891d8a1ff3a481f290741\"> </a><a name=\"composition-en-e8001a6516c891d8a1ff3a481f290741-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/1/13/892/001</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 - tivicay</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>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/13/892/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mpe8001a6516c891d8a1ff3a481f290741" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - tivicay"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What Tivicay is and what it is used for</li><li>What you need to know before you take Tivicay</li><li>How to take Tivicay</li><li>Possible side effects</li><li>How to store Tivicay</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What tivicay is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What tivicay is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Tivicay contains the active ingredient dolutegravir. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).</p><p>Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children of at least 6 years of age or older, and who weigh at least 14 kg.</p><p>Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. As a result of that, it also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.</p><p>Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of your treatment.</p><p>Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).<br/>To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take tivicay" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take tivicay" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Don t take Tivicay:</p><ul><li>if you (or your child, if they are the patient) are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).</li><li>if you (or your child) are taking another medicine called fampridine (also known as dalfampridine; used in multiple sclerosis). If you think any of these apply to you (or your child), tell your doctor.</li></ul><p>Warnings and precautions<br/>Look out for important symptoms<br/>Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:</p><ul><li>symptoms of infections and inflammation</li><li>joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you (or your child, if they are the patient) are taking Tivicay.<br/>Read the information in Section 4 of this leaflet.</li></ul><p>Children Do not give this medicine to children under 6 years of age, weighing less than 14 kg or with HIV infection that is resistant to other medicines similar to Tivicay. The use of Tivicay film-coated tablets in children under 6 or weighing less than 14 kg has not yet been studied.</p><p>Children must keep planned doctor s appointments (see Use in children and adolescents in Section 3 for more information).</p><p>Other medicines and Tivicay Tell your doctor if you (or your child) are taking, have recently taken or are planning to take any other medicines.</p><p>Don't take Tivicay with the following medicine:</p><ul><li>fampridine (also known as dalfampridine), used in multiple sclerosis.</li></ul><p>Some medicines can affect how Tivicay works, or make it more likely that you will have side effects. Tivicay can also affect how some other medicines work.<br/>Tell your doctor if you (or your child) are taking any of the medicines in the following list:</p><ul><li><p>metformin, to treat diabetes</p></li><li><p>medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3).</p></li><li><p>calcium supplements, iron supplements and multivitamins. Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).</p></li><li><p>etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection</p></li><li><p>rifampicin, to treat tuberculosis (TB) and other bacterial infections</p></li><li><p>phenytoin and phenobarbital, to treat epilepsy</p></li><li><p>oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder</p></li><li><p>St. John s wort (Hypericum perforatum), a herbal remedy to treat depression</p><p>Tell your doctor or pharmacist if you (or your child) are taking any of these. Your doctor may decide to adjust your dose or that you need extra check ups.</p></li></ul><p>Pregnancy<br/>If you are pregnant, think you may be pregnant, or if you are planning to have a baby:</p><p>Talk to your doctor about the risks and benefits of taking Tivicay.</p><p>Taking Tivicay at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord). If you could get pregnant while receiving Tivicay:</p><p>Talk to your doctor and discuss whether there is a need for contraception, such as condom or pills.</p><p>Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking Tivicay without consulting your doctor, as this may harm you and your unborn child. Breast-feeding<br/>Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.</p><p>A small amount of the ingredient in Tivicay can pass into your breast milk.</p><p>If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.</p><p>Driving and using machines<br/>Tivicay can make you dizzy and have other side effects that make you less alert.</p><p>Don t drive or operate machinery unless you are sure you re not affected.</p><p>Tivicay contains less than 1 mmol sodium (23 mg) per tablet, that is to say is essentially sodium-free.</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take tivicay" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take tivicay" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<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><ul><li>The usual dose is 50 mg once a day.</li><li>If you are taking certain other medicines, the dose is 50 mg twice a day.</li><li>For HIV that is resistant to other medicines similar to Tivicay, the usual dose is 50 mg, twice a day.</li></ul><p>Your doctor will decide on the correct dose of Tivicay for you.</p><p>Swallow the tablet(s) with some liquid.</p><p>Tivicay can be taken with or without food. When Tivicay is taken twice a day, your doctor may advise you to take with food.</p><p>Tivicay is also available as dispersible tablets. Film-coated tablets and dispersible tablets are not the same, therefore do not switch between film-coated tablets and dispersible tablets without first talking to your doctor.</p><p>Use in children and adolescents</p><ul><li><p>Children s dose of Tivicay needs to be adjusted as they get older or gain weight.</p><p>It is important therefore that children keep planned doctor s appointments.</p></li><li><p>Children and adolescents weighing at least 20 kg can take the adult dose of 50 mg, once a day or mg twice daily. Your doctor will decide how Tivicay should be given.</p></li><li><p>For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child.</p></li><li><p>To reduce the risk of choking, children must not swallow more than one tablet at a time.</p></li><li><p>Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.</p></li></ul><p>Antacid medicines Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.<br/>Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay.</p><p>Talk to your doctor for further advice on taking acid-lowering medicines with Tivicay.</p><p>Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective. Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.</p><p>Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay.</p><p>If you take more Tivicay than you should<br/>If you (or your child) take too many tablets of Tivicay, contact your doctor or pharmacist for advice. If possible, show them the Tivicay pack.</p><p>If you forget to take Tivicay<br/>If you (or your child) miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.</p><p>Don't take a double dose to make up for a missed dose.</p><p>Don t stop taking Tivicay without advice from your doctor<br/>Take Tivicay for as long as your doctor recommends. Don t stop unless your doctor advises you to.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, but not everybody gets them.</p><p>Allergic reactions These are uncommon in people taking Tivicay. Signs include: skin rash a high temperature (fever) lack of energy (fatigue) swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing muscle or joint aches. See a doctor straight away. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.</p><p>Very common side effects<br/>These may affect more than 1 in 10 people: headache diarrhoea feeling sick (nausea).</p><p>Common side effects<br/>These may affect up to 1 in 10 people: rash itching (pruritus) being sick (vomiting) stomach pain (abdominal pain) stomach (abdominal) discomfort weight gain insomnia dizziness abnormal dreams depression (feelings of deep sadness and unworthiness) anxiety lack of energy (fatigue) wind (flatulence) increase in the level of liver enzymes increase in the level of enzymes produced in the muscles (creatine phosphokinase).</p><p>Uncommon side effects<br/>These may affect up to 1 in 100 people: inflammation of the liver (hepatitis) suicide attempt* suicidal thoughts*<br/>panic attack joint pain muscle pain</p><ul><li>particularly in patients who have had depression or mental health problems before.</li></ul><p>Rare side effects<br/>These may affect up to 1 in 1000 people: liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine) increase in bilirubin (a test of liver function) in your blood. suicide (particularly in in patients who have had depression or mental health problems before)</p><p>Tell your doctor immediately if you experience any mental health problems (see also other mental health problems above).</p><p>Symptoms of infection and inflammation<br/>People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been silent and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following: headache stomach ache difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include: palpitations (rapid or irregular heartbeat) or tremor hyperactivity (excessive restlessness and movement)<br/>weakness beginning in the hands and feet and moving up towards the trunk of the body.</p><p>If you (or your child) get any symptoms of infection and inflammation or if you notice any of the symptoms above:</p><p>Tell your doctor immediately. Don t take other medicines for the infection without your doctor s advice.</p><p>Joint pain, stiffness and bone problems Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition: if they have been taking combination therapy for a long time if they are also taking anti-inflammatory medicines called corticosteroids if they drink alcohol if their immune systems are very weak if they are overweight. Signs of osteonecrosis include: stiffness in the joints aches and pains in the joints (especially in the hip, knee or shoulder) difficulty moving. If you notice any of these symptoms:</p><p>Tell your doctor.</p><p>Weight, blood lipid and blood glucose effects<br/>During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will test for these changes.</p><p>Reporting of side effects<br/>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>" ] ] [ fhir:title [ fhir:v "5. How to store tivicay" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store tivicay" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir: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 after EXP on the carton and bottle.</p><p>Tivicay 10 mg film-coated tablets Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Do not swallow the desiccant. This medicine does not require any special temperature storage conditions.</p><p>Tivicay 25 mg and 50 mg film-coated tablets 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>" ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Tivicay contains</p><ul><li>The active substance is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.</li><li>The other ingredients are mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, poly(vinyl alcohol) partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 mg and 50 mg tablets, iron oxide yellow (E172).</li></ul><p>What Tivicay looks like and contents of the pack Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code SV 572 on one side and 10 on the other side. The bottle contains a desiccant to reduce moisture. Once the bottle has been opened keep the desiccant in the bottle, do not remove it.</p><p>Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code SV 572<br/>on one side and 25 on the other side.</p><p>Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code SV 572 on one side and 50 on the other side.</p><p>The film-coated tablets are provided in bottles containing 30 or 90 tablets. Not all pack sizes may be available in your country.</p><p>Marketing Authorisation Holder ViiV Healthcare BV Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands.</p><p>Manufacturer<br/>Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR Delpharm Pozna Sp ka Akcyjna, ul., Grunwaldzka 189, 60-322 Poznan, Poland.</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien ViiV Healthcare srl/bv<br/>T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV Tel: + 370 80000<br/>ViiV Healthcare BV Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv<br/>Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 <a href=\"mailto:cz.info@gsk.com\">cz.info@gsk.com</a></p><p>Magyarorsz g ViiV Healthcare BV Tel: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 <a href=\"mailto:dk-info@gsk.com\">dk-info@gsk.com</a></p><p>Malta ViiV Healthcare BV Tel: + 356 80065Deutschland ViiV Healthcare GmbH<br/>Tel.: + 49 (0)89 203 <a href=\"mailto:0038-viiv.med.info@viivhealthcare.com\">0038-viiv.med.info@viivhealthcare.com</a></p><p>Nederland ViiV Healthcare BV<br/>Tel: + 31 (0)33 2081Eesti ViiV Healthcare BV Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20<br/>GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 <a href=\"mailto:at.info@gsk.com\">at.info@gsk.com</a></p><p>Espa a Polska Laboratorios ViiV Healthcare, S.L.<br/>Tel: + 34 900 923 <a href=\"mailto:es-ci@viivhealthcare.com\">es-ci@viivhealthcare.com</a></p><p>GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS<br/>T l.: + 33 (0)1 39 17 69 <a href=\"mailto:Infomed@viivhealthcare.com\">Infomed@viivhealthcare.com</a></p><p>Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA<br/>Tel: + 351 21 094 08 <a href=\"mailto:viiv.fi.pt@viivhealthcare.com\">viiv.fi.pt@viivhealthcare.com</a></p><p>Hrvatska ViiV Healthcare BV Tel: + 385 800787Rom nia ViiV Healthcare BV<br/>Tel: + 40800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV Tel: + 386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika ViiV Healthcare BV Tel: + 421 800500Italia ViiV Healthcare S.r.l<br/>Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30<br/>ViiV Healthcare BV : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 <a href=\"mailto:info.produkt@gsk.com\">info.produkt@gsk.com</a></p><p>Latvija ViiV Healthcare BV Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 <a href=\"mailto:221customercontactuk@gsk.com\">221customercontactuk@gsk.com</a></p><p>This leaflet was last revised in {month 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>" ] ] ) ] ) . # <MedicinalProductDefinition/mpe8001a6516c891d8a1ff3a481f290741> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mpe8001a6516c891d8a1ff3a481f290741"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpe8001a6516c891d8a1ff3a481f290741\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpe8001a6516c891d8a1ff3a481f290741</b></p><a name=\"mpe8001a6516c891d8a1ff3a481f290741\"> </a><a name=\"hcmpe8001a6516c891d8a1ff3a481f290741\"> </a><a name=\"mpe8001a6516c891d8a1ff3a481f290741-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/13/892/001</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>: Tivicay 10 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>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/13/892/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "Tivicay 10 mg film-coated tablets" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "en" ] ] ) ] ] ) ] ) . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
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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.
