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\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-a48fce64d5ddc98dc0fe03d5edc214e9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-a48fce64d5ddc98dc0fe03d5edc214e9</b></p><a name=\"composition-en-a48fce64d5ddc98dc0fe03d5edc214e9\"> </a><a name=\"hccomposition-en-a48fce64d5ddc98dc0fe03d5edc214e9\"> </a><a name=\"composition-en-a48fce64d5ddc98dc0fe03d5edc214e9-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/1/17/1235/001</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 - zejula</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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"title" : "TEST PURPOSES ONLY - zejula",
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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 Zejula is and what it is used for</li><li>What you need to know before you take Zejula</li><li>How to take Zejula</li><li>Possible side effects</li><li>How to store Zejula</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What zejula is and what it is used for",
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"text" : "1. What zejula is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Zejula is and how it works Zejula contains the active substance niraparib. Niraparib is a type of anti-cancer medicine called a PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. This results in tumour cell death, helping to control the cancer.</p><p>What Zejula is used for Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen).</p><p>Zejula is used for cancer that has:</p><ul><li>responded to the first treatment with platinum-based chemotherapy, or</li><li>come back (recurred) after the cancer has responded to previous treatment with standard platinum-based chemotherapy.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Zejula</p><ul><li>if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).</li><li>if you are breast-feeding.</li></ul><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:</p><p>Low blood-cell counts Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia). Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information). Your doctor will test your blood regularly throughout your treatment.</p><p>Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may want to test your bone marrow to check for these problems.</p><p>High blood pressure Zejula can cause high blood pressure, which in some cases, could be severe. Your doctor will measure your blood pressure regularly throughout your treatment. He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary. Your doctor may advise home blood pressure monitoring and instruction on when to contact him or her in case of a rise in blood pressure.</p><p>Posterior reversible encephalopathy syndrome (PRES) A rare neurological side effect named PRES has been associated with Zejula treatment. If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.</p><p>Children and adolescents Children under 18 years of age should not be given Zejula. This medicine has not been studied in this age group.</p><p>Other medicines and Zejula Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Pregnancy<br/>Zejula should not be taken during pregnancy as it could harm your baby. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.</p><p>If you are a woman who could become pregnant you must use highly effective contraception while you are taking Zejula, and you must continue to use highly effective contraception for 6 months after taking your last dose. Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment. Contact your doctor straightaway if you become pregnant while you are taking Zejula.</p><p>Breast-feeding Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk. If you are breast-feeding, you must stop before you start taking Zejula and you must not begin breast-feeding again until 1 month after taking your last dose. Ask your doctor for advice before taking this medicine.</p><p>Driving and using machines<br/>When you are taking Zejula it may make you feel weak, unfocused, tired or dizzy and therefore influence your ability to drive and use machines. Observe caution when driving or using machines.</p><p>Zejula contains lactose<br/>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.</p><p>Zejula contains tartrazine (E 102) It may cause allergic reactions.</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>For ovarian cancer that has responded to the first treatment with platinum-based chemotherapy The recommended starting dose is 200 mg (two 100 mg capsules), taken together once a day, with or without food. If you weigh 77 kg and have platelet count 150,000/ L before starting treatment, the recommended starting dose is 300 mg (three 100 mg capsules), taken together once a day, with or without food.</p><p>For ovarian cancer that has come back (recurred) The recommended starting dose is 300 mg (three 100 mg capsules), taken together once a day, with or without food.</p><p>Take Zejula at approximately the same time each day. Taking Zejula at bedtime may help you to manage nausea.</p><p>Your doctor may adjust your starting dose if you have problems with your liver.</p><p>Swallow the capsules whole, with some water. Do not chew or crush the capsules. This will ensure the medicine works as well as possible.</p><p>Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/bruising, anaemia).</p><p>Your doctor will check you on a regular basis, and you will normally continue to take Zejula as long as you experience benefit, and do not suffer unacceptable side effects.</p><p>If you take more Zejula than you should<br/>If you take more than your normal dose, contact your doctor immediately.</p><p>If you forget to take Zejula<br/>Do not take an additional dose if you miss a dose or vomit after taking Zejula. Take your next dose at its scheduled time. Do not take a double dose to make up for a forgotten dose.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</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>Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia).</li><li>Being short of breath, feeling very tired, having pale skin, or fast heartbeat -- these may be signs of a low red blood cell count (anaemia).</li><li>Fever or infection low white blood cell count (neutropenia) can increase your risk for infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine. Some infections can be serious and may lead to death.</li><li>Reduction in the number of white cells in the blood (leukopenia)</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>Allergic reaction (including severe allergic reaction that can be life-threatening). Signs include raised and itchy rash (hives) and swelling sometimes of the face or mouth (angioedema), causing difficulty in breathing, and collapse or loss of consciousness.</li><li>Low blood cell counts due to a problem in the bone marrow or blood cancer starting from the bone marrow myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>Fever with low white blood cell count (febrile neutropenia)</li><li>Reduction in the number of red blood cells, white blood cells and platelets (pancytopenia)</li></ul><p>Rare (may affect up to 1 in 1000 people)</p><ul><li>A sudden increase in blood pressure, which may be a medical emergency that could lead to organ damage or can be life-threatening.</li><li>A brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES), which is a medical emergency that could lead to organ damage or can be life-threatening.</li></ul><p>Talk to your doctor if you get any other side effects. These can include:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>Feeling sick (nausea)</li><li>Decreased number of white cells in the blood</li><li>Decreased number of platelets in the blood</li><li>Decreased number of red cells in the blood (anaemia)</li><li>Feeling tired</li><li>Feeling of weakness</li><li>Constipation</li><li>Vomiting</li><li>Stomach pain</li><li>Inability to sleep</li><li>Headache</li><li>Decreased appetite</li><li>Runny or stuffy nose</li><li>Diarrhoea</li><li>Shortness of breath</li><li>Back pain</li><li>Joint pain</li><li>High blood pressure</li><li>Indigestion (dyspepsia)</li><li>Dizziness</li><li>Cough</li><li>Urinary tract infection</li><li>Palpitations (feeling like your heart is skipping beats or beating harder than usual)</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>Sunburn-like reactions following exposure to light</li><li>Swelling in the feet, ankles, legs, and/or hands</li><li>Low potassium levels in the blood</li><li>Inflammation or swelling of the air passages between the mouth and nose and the lungs, bronchitis</li><li>Abdominal bloating</li><li>Feeling of worry, nervousness, or unease</li><li>Feelings of sadness, depressed</li><li>Nose bleed</li><li>Decrease in weight</li><li>Muscle pain</li><li>Impaired concentration, understanding, memory and thinking (cognitive impairment)</li><li>Pink eye</li><li>Fast heart beat may cause dizziness, chest pain or breathlessness</li><li>Dry mouth</li><li>Inflammation of the mouth and/or digestive tract</li><li>Rash</li><li>Elevated blood tests</li><li>Abnormal blood tests</li><li>Abnormal taste in mouth</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>Confusional state</li><li>Inflammation of the lungs which can cause shortness of breath and difficulty breathing (non- infectious pneumonitis)</li></ul><p>Reporting of side effects<br/>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.</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 blister after EXP. The expiry date refers to the last day of that month.</p><p>Do not store above 30 C.</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 Zejula contains</p><ul><li><p>The active substance is niraparib. Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.</p></li><li><p>The other ingredients (excipients) are: Capsule content: magnesium stearate, lactose monohydrate Capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102) Printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), povidone (E 1201), and titanium dioxide (E 171).</p></li></ul><p>This medicine contains lactose and tartrazine - see section 2 for more information.</p><p>What Zejula looks like and contents of the pack</p><p>Zejula hard capsules have a white opaque body and a purple opaque cap. The white opaque capsule body is printed with 100 mg in black ink, and the purple capsule cap is printed with Niraparib in white ink. The capsules contain a white to off-white powder.</p><p>The hard capsules are packed in unit dose blister packs of</p><ul><li>84 1 hard capsules</li><li>56 1 hard capsules</li><li>28 1 hard capsules</li></ul><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk Citywest Business Campus Dublin Ireland</p><p>Manufacturer GlaxoSmithKline Trading Services Ltd. 12 Riverwalk Citywest Business Campus Dublin Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva GlaxoSmithKline (Ireland) Limited<br/>Tel: + 370 80000<br/>GlaxoSmithKline (Ireland) Limited Te .: + 359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 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 GlaxoSmithKline (Ireland) Limited<br/>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 GlaxoSmithKline (Ireland) Limited Tel: + 356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 <a href=\"mailto:8produkt.info@gsk.com\">8produkt.info@gsk.com</a> Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline (Ireland) Limited<br/>Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 Tel: + 372 8002<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 GlaxoSmithKline, S.A. Tel: + 34 900 202 <a href=\"mailto:es-ci@gsk.com\">es-ci@gsk.com</a></p><p>Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0)1 39 17 84 <a href=\"mailto:diam@gsk.com\">diam@gsk.com</a> Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 <a href=\"mailto:FI.PT@gsk.com\">FI.PT@gsk.com</a></p><p>Hrvatska GlaxoSmithKline (Ireland) Limited Tel: +385 800787Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Rom nia GlaxoSmithKline (Ireland) Limited Tel: + 40 800672Slovenija GlaxoSmithKline (Ireland) Limited Tel: + 386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika GlaxoSmithKline (Ireland) Limited<br/>Tel: + 421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30<br/>GlaxoSmithKline (Ireland) Limited : + 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 GlaxoSmithKline (Ireland) Limited Tel: + 371 80205United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 <a href=\"mailto:221customercontactuk@gsk.com\">221customercontactuk@gsk.com</a></p><p>This leaflet was last revised in MM/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>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpa48fce64d5ddc98dc0fe03d5edc214e9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpa48fce64d5ddc98dc0fe03d5edc214e9</b></p><a name=\"mpa48fce64d5ddc98dc0fe03d5edc214e9\"> </a><a name=\"hcmpa48fce64d5ddc98dc0fe03d5edc214e9\"> </a><a name=\"mpa48fce64d5ddc98dc0fe03d5edc214e9-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/17/1235/001</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>: Zejula 100 mg hard capsules</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/1/17/1235/001"
}
],
"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" : "Zejula 100 mg hard capsules",
"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.
