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 HALAVEN is and what it is used for</li><li>What you need to know before you use HALAVEN</li><li>How to use HALAVEN</li><li>Possible side effects</li><li>How to store HALAVEN</li><li>Contents of the pack and other information</li></ol></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>HALAVEN contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.</p><p>It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.</p><p>It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use HALAVEN:</p><ul><li>if you are allergic to eribulin mesilate 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 Talk to your doctor or nurse before using HALAVEN:</p><ul><li>if you have liver problems</li><li>if you have a fever or an infection</li><li>if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness</li><li>if you have heart problems</li></ul><p>If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.</p><p>Children and adolescents</p><p>Do not give this medicine to children between the ages of 0 to 18 years because it does not work.</p><p>Other medicines and HALAVEN Tell your doctor if you are using, have recently used or might use any other medicines.</p><p>Pregnancy, breast-feeding and fertility HALAVEN may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraception during and up to 3 months after treatment with HALAVEN.</p><p>HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.</p><p>Driving and using machines HALAVEN may cause side effects such as tiredness (very common) and dizziness (common). Do not drive or use machines if you feel tired or dizzy.</p><p>HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>HALAVEN will be given to you by a qualified healthcare professional as an injection into a vein, over a period of 2 to 5 minutes. The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors. To ensure that the whole dose of HALAVEN is given it is recommended that a saline solution is flushed into the vein after HALAVEN is given.</p><p>How often will you be given HALAVEN? HALAVEN is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.</p><p>If you have any further questions about 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>If you experience any of the following serious symptoms, stop taking HALAVEN and seek medical attention straightaway:</p><ul><li>Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion. These may be signs of a condition called sepsis a severe and serious reaction to an infection. Sepsis is uncommon (may affect up to 1 in 100 people) and can be life- threatening and may result in death.</li><li>Any difficulty breathing, or swelling of your face, mouth, tongue or throat. These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).</li><li>Serious skin rashes with blistering of the skin, mouth, eyes and genitals. These may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is not known but it can be life-threatening.</li></ul><p>Other side effects:</p><p>Very common side effects (may affect more than 1 in 10 people) are:</p><ul><li>Decrease in the number of white blood cells or red blood cells</li><li>Tiredness or weakness</li><li>Nausea, vomiting, constipation, diarrhoea</li><li>Numbness, tingling or prickling sensations</li><li>Fever</li><li>Loss of appetite, weight loss</li><li>Difficulty breathing, cough</li><li>Pain in the joints, muscles and back</li><li>Headache</li><li>Hair loss</li></ul><p>Common side effects (may affect up to 1 in 10 people) are:</p><ul><li>Decrease in the number of platelets (which may result in bruising or taking longer to stop bleeding)</li><li>Infection with fever, pneumonia, chills</li><li>Fast heart rate, flushing</li><li>Vertigo, dizziness</li><li>Increased production of tears, conjunctivitis (redness and soreness of the surface of the eye), nosebleed</li><li>Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling</li><li>Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness</li><li>Mouth, respiratory and urinary tract infections, painful urination</li><li>Sore throat, sore or runny nose, flu-like symptoms, throat pain</li><li>Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium, magnesium or calcium in the blood</li><li>Inability to sleep, depression, changed sense of taste</li><li>Rash, itching, nail problems, dry or red skin</li><li>Excessive sweating (including night sweats)</li><li>Ringing in the ears</li><li>Blood clots in the lungs</li><li>Shingles</li><li>Swelling of the skin and numbness of the hands and feet</li></ul><p>Uncommon side effects (may affect up to 1 in 100 people) are:</p><ul><li>Blood clots</li><li>Abnormal liver function tests (hepatoxicity)</li><li>Kidney failure, blood or protein in the urine</li><li>Widespread inflammation of the lungs which may lead to scarring</li><li>Inflammation of the pancreas</li><li>Mouth ulcers</li></ul><p>Rare side effects (may affect up to 1 in 1000 people) are:</p><ul><li>A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor 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 the vial 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>If HALAVEN is diluted for infusion, the diluted solution should be used immediately. If not used immediately the diluted solution should be stored at 2- 8 C for no longer than 72 hours.</p><p>If HALAVEN as an undiluted solution has been transferred into a syringe, it should be stored at 15- 25 C and ambient lighting for no longer than 4 hours, or at 2- 8 C for no longer than 24 hours.</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 HALAVEN contains</p><ul><li>The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.</li><li>The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.</li></ul><p>What HALAVEN looks like and contents of the pack</p><p>HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml of solution. Each carton contains either 1 or 6 vials.</p><p>Marketing Authorisation Holder Eisai GmbH Edmund-Rumpler-Stra e 3<br/>60549 Frankfurt am Main Germany e-mail: <a href=\"mailto:medinfo_de@eisai.net\">medinfo_de@eisai.net</a></p><p>Manufacturer Eisai GmbH Edmund-Rumpler-Stra e 3<br/>60549 Frankfurt am Main Germany</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Eisai SA/NV T l/Tel: +32 (0)800 158 Lietuva Ewopharma AG Tel: +370 5 248 73<br/>Ewopharma AG Te : +359 2 962 12 Luxembourg/Luxemburg Eisai SA/NV T l/Tel: + 32 (0)800 158 (Belgique/Belgien) esk republika Eisai GesmbH organiza n slo ka Tel.: + 420 242 485 Magyarorsz g Ewopharma Hungary Ltd. Tel: +36 1 200 46 Danmark Eisai AB Tlf: + 46 (0) 8 501 01 (Sverige) Malta Cherubino LTD Tel: +356 21343Deutschland Eisai GmbH Tel: + 49 (0) 69 66 58 Nederland Eisai B.V. T l/Tel: + 31 (0) 900 575 3Eesti Ewopharma AG Tel. +370 5 248 73 Norge Eisai AB Tlf: + 46 (0) 8 501 01 (Sverige)</p><p>Eisai Ltd. : + 44 (0)208 600 1( ) sterreich Eisai GesmbH Tel: + 43 (0) 1 535 1980-0 Espa a Eisai Farmac utica, S.A. Tel: + (34) 91 455 94 Polska Ewopharma AG Sp. z o.o. Tel.: +48 (22) 620 11 France Eisai SAS T l: + (33) 1 47 67 00 Portugal Eisai Farmac utica, Unipessoal Lda Tel: + 351 214 875 Hrvatska Ewopharma d.o.o. Tel: +385 (0) 1 6646 Rom nia<br/>Ewopharma AG<br/>Tel: +40 21 260 13 Ireland Eisai GmbH Tel: + 49 (0) 69 66 58 (Germany) Slovenija Ewopharma d.o.o. Tel: +386 590 848 sland Eisai AB S mi: + 46 (0)8 501 01 (Sv j ) Slovensk republika Eisai GesmbH organiza n slo ka Tel.: + 420 242 485 ( esk republika) Italia Eisai S.r.l. Tel: + 39 02 5181Suomi/Finland Eisai AB Puh/Tel: + 46 (0) 8 501 01 (Ruotsi)</p><p>Eisai Ltd. : +44 (0)208 600 1( ) Sverige Eisai AB Tel: + 46 (0) 8 501 01 Latvija Ewopharma AG Tel: +371 677 04United Kingdom (Northern Ireland) Eisai GmbH Tel: + 49 (0) 69 66 58 (Germany)</p><p>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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}
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.
