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 Dacogen is and what it is used for</li><li>What you need to know before you use Dacogen</li><li>How to use Dacogen</li><li>Possible side effects</li><li>How to store Dacogen</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What dacogen is and what it is used for",
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"text" : "1. What dacogen is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Dacogen is Dacogen is an anti-cancer medicine. It contains the active substance decitabine . What Dacogen is used for Dacogen is used to treat a type of cancer called acute myeloid leukaemia or AML . This is a type of cancer that affects your blood cells. You will be given Dacogen when you are first diagnosed with AML. It is used in adults. How Dacogen works Dacogen works by stopping cancer cells from growing. It also kills cancer cells. Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Dacogen</p><p>if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).</p><p>if you are breast-feeding. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Dacogen. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Dacogen if you have</p><p>low numbers of platelets, red blood cells or white blood cells,</p><p>an infection,</p><p>liver disease,</p><p>a serious kidney disorder,</p><p>a heart disorder. If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Dacogen. Dacogen can cause a serious immune reaction called differentiation syndrome (see section 4. Possible side effects ). Tests or checks You will have blood tests before you start treatment with Dacogen and at the start of each treatment cycle. These tests are to check that:</p><p>you have enough blood cells, and</p><p>your liver and kidneys are working properly. Talk to your doctor about what your blood test results mean. Children and adolescents Dacogen is not for use in children or adolescents under the age of 18. Other medicines and Dacogen Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Dacogen can affect the way some other medicines work. Also, some other medicines can affect the way Dacogen works. Pregnancy and breast-feeding</p><p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.</p><p>You should not use Dacogen if you are pregnant as it may harm your baby. If you are able to become pregnant, your doctor will ask you to take a pregnancy test before you start treatment with Dacogen. Tell your doctor immediately if you become pregnant during treatment with Dacogen.</p><p>Do not breast-feed if you are using Dacogen. This is because it is not known if the medicine passes into the mother s milk. Male and female fertility and contraception</p><p>Men should not father a child while using Dacogen.</p><p>Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.</p><p>Talk to your doctor if you wish to conserve your sperm before starting treatment.</p><p>Women who are able to become pregnant must use effective contraception during treatment and for 6 months following completion of treatment.</p><p>Talk to your doctor if you wish to freeze your eggs before starting treatment. Driving and using machines You may feel tired or weak after using Dacogen. If this happens, do not drive or use any tools or machines. Dacogen contains potassium and sodium</p><p>This medicine contains 0.5 mmol potassium in each vial. After preparing the medicine, it contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially potassium- free .</p><p>This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial. After preparing the medicine, it contains between 13.8 mg-138 mg sodium per dose, equivalent to 0.7-7% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor if you are on a low salt diet.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Dacogen will be given to you by a doctor or nurse who is trained in giving this type of medicine. How much to use</p><p>Your doctor will work out your dose of Dacogen. This depends on your height and weight (body surface area).</p><p>The dose is 20 mg/m2 body surface area.</p><p>You will receive Dacogen every day for 5 days, then 3 weeks without the medicine. This is called a treatment cycle and it is repeated every 4 weeks. You will usually receive at least 4 treatment cycles.</p><p>Your doctor may delay your dose and change the total number of cycles, depending on how you respond to the treatment. How Dacogen is given The solution is given into a vein (as an infusion). This will take one hour. If you are given more Dacogen than you should This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects and manage them accordingly. If you forget your appointment to have Dacogen If you miss an appointment, make another one as soon as possible. This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule. If you have any further questions on the use of this medicine, ask your doctor 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. The following side effects may happen with this medicine. Tell your doctor or nurse immediately if you notice any of the following serious side effects</p><p>Fever: this may be a sign of an infection caused by low levels of white blood cells (very common).</p><p>Chest pain or shortness of breath (with or without fever or cough): these may be signs of an infection of the lung called pneumonia (very common) or inflamed lungs (interstitial lung disease [frequency not known]) or cardiomyopathy (heart muscle disease [uncommon]) which can be accompanied with swelling of ankles, hands, legs and feet.</p><p>Bleeding: including blood in the stools. This may be a sign of bleeding in the stomach or gut (common).</p><p>Difficultly with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body. These may be signs of bleeding inside your head (common).</p><p>Difficulty breathing, swelling of the lips, itching or rash: This may be due to an allergic (hypersensitivity) reaction (common).</p><p>Serious immune reaction (differentiation syndrome) that may cause fever, cough, difficulty breathing, rash, decreased urine, hypotension (low blood pressure), swelling of the arms or legs and rapid weight gain (not known). Tell your doctor or nurse immediately if you notice any of the serious side effects above. Other side effects of Dacogen include Very common (may affect more than 1 in 10 people)</p><p>urine infection</p><p>other infection in any part of the body, caused by bacteria, virus or fungi</p><p>bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets (thrombocytopaenia)</p><p>feeling tired or looking pale - these may be signs of a drop in the number of red blood cells (anaemia)</p><p>high level of sugar in the blood</p><p>headache</p><p>nose bleeds</p><p>diarrhoea</p><p>vomiting</p><p>nausea</p><p>fever</p><p>abnormal liver function Common (may affect up to 1 in 10 people)</p><p>an infection of the blood caused by bacteria - this may be a sign of a low level of white blood cells</p><p>sore or runny nose, sore sinuses</p><p>mouth or tongue ulcers</p><p>high level of bilirubin in the blood Uncommon (may affect up to 1 in 100 people)</p><p>a drop in the number of red blood cells, white blood cells and platelets (pancytopaenia)</p><p>heart muscle disease</p><p>red, raised painful patches on the skin, fever, an increase in white blood cells - these may be signs of Acute Febrile Neutrophilic Dermatosis or Sweet s Syndrome Not known (frequency cannot be estimated from the available data)</p><p>inflamed gut (enterocolitis, colitis and caecitis), with symptoms of abdominal pain, bloating, or diarrhoea. Enterocolitis may lead to septic complications and may be associated with fatal outcome. Reporting of side effects If you get 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>Your doctor, nurse or pharmacist is responsible for storing Dacogen.</p><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 the vial label after EXP. The expiry date refers to the last day of that month.</p><p>Do not store above 25 C.</p><p>After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids. This prepared diluted solution can be stored refrigerated at 2 C - 8 C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20 C - 25 C) before administration.</p><p>Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Dacogen contains</p><p>The active substance is decitabine. Each vial of powder contains 50 mg decitabine. After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.</p><p>The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524), and hydrochloric acid (for pH-adjustment). See section 2. What Dacogen looks like and contents of the pack Dacogen is a white to almost white powder for concentrate for solution for infusion. It is supplied in a 20 ml glass vial containing 50 mg decitabine. Each pack contains 1 vial. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 Lietuva UAB \"JOHNSON & JOHNSON\" Tel: +370 5 278 68<br/>&<br/>.: +359 2 489 94 Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel: +36 1 884 2Danmark Janssen-Cilag A/S Tlf: +45 4594 8Malta AM MANGION LTD. Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 Nederland Janssen-Cilag B.V. Tel: +31 76 711 1Eesti UAB \"JOHNSON & JOHNSON\" Eesti filiaal Tel: +372 617 7Norge Janssen-Cilag AS Tlf: +47 24 12 65<br/>Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 Polska Janssen-Cilag Polska Sp. z o.o. Tel: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.77 / +39 02 2510 1 Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531</p><p>: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 Latvija UAB \"JOHNSON & JOHNSON\" fili le Latvij Tel: +371 678 93United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 This leaflet was last revised in MM/YYYY Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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"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.
