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 Thyrogen is and what it is used for</li><li>What you need to know before you use Thyrogen</li><li>How to use Thyrogen</li><li>Possible side effects</li><li>How to store Thyrogen</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What thyrogen is and what it is used for",
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"text" : "1. What thyrogen is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes.</p><p>Thyrogen is used to detect certain types of thyroid cancer in patients who have had their thyroid gland removed and who are taking thyroid hormones. One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging. It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left. These hormones can be measured in your blood.</p><p>Thyrogen is also used with radioiodine treatment to eliminate (ablate) the thyroid tissue left over after surgical removal of the thyroid gland (remnant) in patients who do not have secondary cancer growths (metastases) and who are taking thyroid hormone.</p></div>"
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"text" : "2. What you need to know before you take thyrogen"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Thyrogen:</p><ul><li>if you are allergic to bovine or human thyroid stimulating hormone (TSH) or any of the other ingredients of this medicine (listed in section 6).</li><li>if you are pregnant.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before using Thyrogen</p><ul><li>if you have kidney disease that requires dialysis and he will decide how much Thyrogen to give to you as you may have more chance of experiencing headache and nausea.</li><li>if you have reduced kidney function and he will decide how much radioiodine to give you.</li><li>if you have reduced liver function; you should still be able to receive Thyrogen.</li></ul><p>Effect on tumour growth In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures. This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period. It is possible that Thyrogen may also cause tumour growth. In clinical trials this was not seen.</p><p>Due to elevation of TSH levels after Thyrogen, patients with secondary cancer growths (metastases) can experience local swelling or bleeding at the site of these metastases which may become bigger. If the metastases are present in narrow spaces e.g. intracerebral (in the brain) or in the spinal cord, patients could experience symptoms which can occur quickly such as partial paralysis affecting one side of the body (hemiparesis), breathing problems or loss of vision.</p><p>Your doctor will decide if you belong to a specific group of patients for which pre-treatment with corticosteroids is to be considered (for example, if you have secondary cancer growths in your brain or spinal cord). Please talk to your doctor about this if you have concerns.</p><p>Children<br/>Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.</p><p>Elderly<br/>No special precautions for elderly patients are necessary. However, if your thyroid gland has not been removed completely and you are also suffering from heart disease, your doctor will help you decide if Thyrogen should be given to you.</p><p>Other medicines and Thyrogen Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.</p><p>Your doctor will determine the exact activity of radioiodine to use for radioiodine imaging, taking into consideration the fact that you continue to take thyroid hormones.</p><p>Pregnancy and breast-feeding Do not take Thyrogen if you are pregnant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.</p><p>Thyrogen should not be given to breast-feeding women. Breast-feeding should only be resumed following advice from your doctor.</p><p>Driving and using machines Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.</p><p>Thyrogen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free .</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Your medicine will be injected by a doctor or a nurse.</p><p>Your treatment should be supervised by a doctor who has expertise in thyroid cancer. Thyrogen powder must be dissolved in water for injection. Only one vial of Thyrogen is required per injection. Thyrogen should only be administered into the buttock muscle. This solution should never be injected into a vein. Thyrogen must not be mixed with other medicines in the same injection.</p><p>The recommended dose of Thyrogen is two doses administered 24 hours apart. Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.</p><p>When you undergo radioiodine imaging or elimination (ablation), your doctor will give you radioiodine 24 hours after your final Thyrogen injection.<br/>Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen). Post-treatment scanning may be delayed a few days to allow background radioactivity to decline.</p><p>For thyroglobulin (Tg) testing, your doctor or nurse will take a serum sample 72 hours after the last injection of Thyrogen.</p><p>Use in children Your child s doctor will help you decide if Thyrogen should be given to your child.</p><p>If you are given more Thyrogen than you should receive Patients who accidentally received too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting and hot flashes.</p><p>A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.</p><p>If you have any further questions on the use of this medicine, ask your doctor.</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>The following effects have been reported with Thyrogen:</p><p>Very common (may affect more than 1 in 10 people):</p><ul><li>nausea</li></ul><p>Common (may affect up to 1 in 10 people):</p><ul><li>vomiting</li><li>fatigue</li><li>dizziness</li><li>headache</li><li>weakness</li></ul><p>Uncommon (may affect up to 1 in 100 people):</p><ul><li>feeling hot</li><li>hives (urticaria)</li><li>rash</li><li>flu symptoms</li><li>fever</li><li>chills</li><li>back pain</li><li>diarrhoea</li><li>prickling or tingling sensation (paraesthesia),</li><li>neck pain</li><li>inability to taste (ageusia)</li><li>impaired sense of taste (dysgeusia)</li><li>influenza</li></ul><p>Not known (frequency cannot be estimated from the available data):</p><ul><li>swelling of the tumour</li><li>pain (including pain at the site of metastases (secondary cancer growths))</li><li>tremor</li><li>stroke</li><li>palpitations</li><li>flushing</li><li>shortness of breath</li><li>itching (pruritus)</li><li>excessive sweating</li><li>muscle or joint pain</li><li>injection site reactions (including redness, discomfort, itching, local pain or stinging, and an itchy rash)</li><li>low TSH</li><li>hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.</li></ul><p>Very rare cases of hyperthyroidism (increased activity of the thyroid gland) or atrial fibrillation have been reported when Thyrogen was administered to patients who had not undergone total or partial removal of the thyroid gland.</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>"
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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 label after EXP . The expiry date refers to the last day of that month.</p><p>Store in a refrigerator (2 C - 8 C). Keep the vial in the outer carton in order to protect from light.</p><p>It is recommended that the Thyrogen solution be injected within three hours after reconstitution. The reconstituted solution can be stored for up to 24 hours in a refrigerator (2 C - 8 C) under protection from light, while avoiding microbial contamination.</p><p>Do not use this medicine if you notice foreign particles, cloudiness or discoloration.</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 Thyrogen contains</p><ul><li><p>The active substance is thyrotropin alfa.<br/>Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection. Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.</p></li><li><p>The other ingredients are:<br/>Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride.</p></li></ul><p>Thyrogen contains sodium, see section 2. What Thyrogen looks like and contents of the pack</p><p>Powder for solution for injection. White to off-white lyophilised powder.</p><p>Pack sizes: one or two vials of Thyrogen per carton.<br/>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Marketing Authorisation Holder: Sanofi B.V. Paasheuvelweg 1105 BP Amsterdam The Netherlands</p><p>Manufacturer:<br/>Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium T l/Tel: + 32 (0)2 710 54 Magyarorsz g SANOFI-AVENTIS Zrt. Tel: +36 1 505 0<br/>Swixx Biopharma EOOD T : +359 (0)2 4942 Malta Sanofi S.r.l. Tel: +39 02 39394 esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Nederland Sanofi B.V. Tel: +31 20 245 4Danmark Sanofi A/S<br/>Tlf: +45 45 16 70 Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 52 52 Tel: aus dem Ausland:+ 49 69 305 21 sterreich sanofi-aventis GmbH Tel: + 43 1 80 185 - 0 Eesti Swixx Biopharma O<br/>Tel. +372 640 10 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00<br/>Sanofi-Aventis AEBE : +30 210 900 16 Portugal Sanofi Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovensk republika Swixx Biopharma s.r.o. Tel.: +421 2 208 33 sland Vistor hf. S mi: +354 535 7Suomi/Finland Sanofi Oy Puh/Tel: + 358 (0) 201 200 Italia Sanofi S.r.l. Tel: 800536<br/>C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2Lietuva Swixx Biopharma UAB Tel. +370 5 236 91 This leaflet was last revised in</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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"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.
