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-66b9e568d1a8891a6ff6349ce2c6c5ff\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-66b9e568d1a8891a6ff6349ce2c6c5ff</b></p><a name=\"composition-en-66b9e568d1a8891a6ff6349ce2c6c5ff\"> </a><a name=\"hccomposition-en-66b9e568d1a8891a6ff6349ce2c6c5ff\"> </a><a name=\"composition-en-66b9e568d1a8891a6ff6349ce2c6c5ff-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/1/09/533/001 10ml bottle</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 - vedrop</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" : "1. What vedrop is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Vedrop contains vitamin E (in the form of tocofersolan). It is used to treat lack of vitamin E due to digestive malabsorption (where nutrients from the food are not easily absorbed during digestion) in patients from birth (full term newborns) up to 18 years of age suffering from chronic cholestasis (a hereditary or congenital disease where bile cannot flow from the liver to the intestine).</p></div>"
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"title" : "2. What you need to know before you take vedrop",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Vedrop</p><ul><li>If you are allergic to vitamin E (d-alpha-tocopherol) or any of the other ingredients of this medicine (listed in section 6).</li><li>Vedrop must not be used in newborn premature babies.</li></ul><p>Warnings and precautions<br/>Talk to your doctor before taking Vedrop if you have:</p><ul><li>Problems with your kidney or dehydration. Vedrop should be used with caution and your kidney function closely monitored, because polyethylene glycol, part of the active substance tocofersolan, may damage your kidneys.</li><li>Problems with your liver. Vedrop should be used with caution and liver functions closely monitored.</li></ul><p>Other medicines and Vedrop Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Tell your doctor or pharmacist if you are taking:</p><ul><li>Certain medicines to thin the blood (oral anticoagulants such as warfarin). Your doctor will ask you to perform blood tests regularly and may adjust their dose to avoid higher risk of bleeding.</li><li>Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine). As Vedrop may increase their absorption during digestion, your doctor will monitor the treatment effect and adjust the doses if necessary.</li></ul><p>Pregnancy and breast-feeding No clinical data are available on exposure to this medicine during pregnancy. Inform your doctor if you are pregnant as he/she will decide if the medicine may be used.<br/>There is no data on whether or not this medicine is present in the breast milk. Inform your doctor if you want to breast-feed. Your doctor will help you decide what is best for you and your child.</p><p>Ask your doctor or pharmacist for advice before taking any medicine.</p><p>Driving and using machines Vedrop is not likely to affect your ability to drive and use machines.</p><p>Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215), which may cause allergic reactions (possibly delayed).</p><p>Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml. Speak to your doctor if you are on a controlled sodium diet.</p></div>"
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"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><p>The usual dose is 0.34 ml/kg/day.<br/>Your doctor will prescribe the dose in ml. The dose will be adjusted by your doctor according to your vitamin E blood level.</p><p>Method of administration Swallow the solution with or without water. Use only with the oral syringe provided in the box.<br/>You can take Vedrop before or during your meal, with or without water.</p><p>To measure the dose:</p><p>1- Open the bottle. 2- Put the oral syringe included in the pack in the bottle.</p><p>3-Fill the oral syringe with the liquid by pulling the plunger up to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.</p><p>4- Remove the oral syringe from the bottle. 5- Empty the contents of the syringe by pushing the plunger to the bottom either:</p><ul><li>directly into the mouth,<br/>or</li><li>into a glass of water and then drink the entire content of the glass.</li></ul><p>6- Close the bottle.<br/>7- Wash the syringe with water.</p><p>If you take more Vedrop than you should If you take large doses of Vitamin E, you may experience temporary diarrhoea and stomach ache. Talk to your doctor or pharmacist if symptoms persist more than two days.</p><p>If you forget to take Vedrop Skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for a forgotten dose.</p><p>If you stop taking Vedrop Do not stop the treatment without consulting your doctor because lack of vitamin E may come back and affect your health. Contact your doctor or pharmacist before stopping.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>"
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"title" : "4. Possible side effects",
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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 side effects were reported:</p><p>Common side effects (may affect up to 1 in 10 people)</p><p>Diarrhoea</p><p>Uncommon side effects (may affect up to 1 in 100 people)</p><p>Asthenia (feeling of weakness)</p><p>Headache</p><p>Loss of hair</p><p>Itching</p><p>Rash (eruption on the skin)</p><p>Abnormal level of sodium in the blood</p><p>Abnormal level of potassium in the blood</p><p>Increase of transaminases (liver enzymes)</p><p>Not known (frequency cannot be estimated from the available data)</p><p>Stomach ache</p><p>Reporting of side effects 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 box and the bottle, after EXP. The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Discard the bottle one month after first opening, even if some solution remains.</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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{
"title" : "6. Contents of the pack and other information",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Vedrop contains</p><ul><li>The active substance is tocofersolan. Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.</li><li>The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.</li></ul><p>What Vedrop looks like and contents of the pack Vedrop is a slightly viscous pale yellow oral solution in a brown glass bottle which is closed with a child- resistant cap. The bottles contain 10 ml, 20 ml or 60 ml of oral solution. Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle).</p><p>Marketing Authorisation Holder Recordati Rare Diseases Immeuble Le Wilson<br/>70 avenue du General de Gaulle 92800 Puteaux France</p><p>Manufacturer Recordati Rare Diseases Immeuble Le Wilson<br/>70, avenue du G n ral de Gaulle F-92800 Puteaux France</p><p>or</p><p>Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.</p><p>Belgique/Belgi /Belgien Recordati T l/Tel: +32 2 46101 Lietuva Recordati AB. Tel: + 46 8 545 80 vedija</p><p>Recordati Rare Diseases Te .: +33 (0)1 47 73 64</p><p>Luxembourg/Luxemburg Recordati T l/Tel: +32 2 46101 Belgique/Belgien</p><p>esk republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francie</p><p>Magyarorsz g Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Franciaorsz g</p><p>Danmark Recordati AB. Tlf : +46 8 545 80 Sverige</p><p>Malta Recordati Rare Diseases Tel: +33 1 47 73 64 Franza</p><p>Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Nederland Recordati Tel: +32 2 46101 Belgi</p><p>Eesti Recordati AB. Tel: + 46 8 545 80 Rootsi</p><p>Norge Recordati AB. Tlf : +46 8 545 80 Sverige</p><p>Recordati Rare Diseases : +33 1 47 73 64</p><p>sterreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland</p><p>Espa a Recordati Rare Diseases Spain S.L.U. Tel: + 34 91 659 28 Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francja</p><p>France Recordati Rare Diseases T l: +33 (0)1 47 73 64 Portugal Jaba Recordati S.A. Tel: +351 21 432 95 Hrvatska Recordati Rare Diseases T l: +33 (0)1 47 73 64 Francuska</p><p>Rom nia Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Fran a</p><p>Ireland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 France</p><p>Slovenija Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Francija</p><p>sland Recordati AB. Simi:+46 8 545 80 Sv j</p><p>Slovensk republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 Franc zsko</p><p>Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 Suomi/Finland Recordati AB. Puh/Tel : +46 8 545 80 Sverige</p><p>Recordati Rare Diseases : +33 1 47 73 64</p><p>Sverige Recordati AB. Tel : +46 8 545 80 Latvija Recordati AB. Tel: + 46 8 545 80 Zviedrija</p><p>United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414This leaflet was last revised in</p><p>This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.<br/>The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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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.
