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 Xiliarx is and what it is used for</li><li>What you need to know before you take Xiliarx</li><li>How to take Xiliarx</li><li>Possible side effects</li><li>How to store Xiliarx</li><li>Contents of the pack and other information</li></ol></div>"
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"text" : "1. What xiliarx is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called oral antidiabetics .</p><p>Xiliarx is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe Xiliarx either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.</p><p>Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon.</p><p>Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances.</p><p>How Xiliarx works Xiliarx works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Xiliarx:</p><ul><li>if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, do not take this medicine and talk to your doctor.</li></ul><p>Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Xiliarx</p><ul><li>if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.</li><li>if you are taking an anti-diabetic medicine known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Xiliarx in order to avoid low blood glucose [hypoglycaemia]).</li><li>if you have moderate or severe kidney disease (you will need to take a lower dose of Xiliarx).</li><li>if you are on dialysis.</li><li>if you have liver disease.</li><li>if you suffer from heart failure.</li><li>if you have or have had a disease of the pancreas.</li></ul><p>If you have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.</p><p>Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. You are also advised to pay particular attention to new onset of blisters or ulcers while taking Xiliarx. Should these occur, you should promptly consult your doctor.</p><p>A test to determine your liver function will be performed before the start of Xiliarx treatment, at three- month intervals for the first year and periodically thereafter. This is so that signs of increased liver enzymes can be detected as early as possible.</p><p>Children and adolescents The use of Xiliarx in children and adolescents up to 18 years of age is not recommended.</p><p>Other medicines and Xiliarx Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines such as:</p><ul><li>thiazides or other diuretics (also called water tablets)</li><li>corticosteroids(generally used to treat inflammation)</li><li>thyroid medicines</li><li>certain medicines affecting the nervous system.</li></ul><p>Pregnancy and breast-feeding 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>You should not use Xiliarx during pregnancy. It is not known if Xiliarx passes into breast milk. You should not use Xiliarx if you are breast-feeding or plan to breast-feed.</p><p>Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.</p><p>Xiliarx contains lactose Xiliarx contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.</p><p>Xiliarx contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free .</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>How much to take and when The amount of Xiliarx people have to take varies depending on their condition. Your doctor will tell you exactly how many tablets of Xiliarx to take. The maximum daily dose is 100 mg.</p><p>The usual dose of Xiliarx is either:</p><ul><li><p>50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine called a sulphonylurea.</p></li><li><p>100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.</p></li><li><p>50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.</p></li></ul><p>How to take Xiliarx</p><ul><li>Swallow the tablets whole with some water.</li></ul><p>How long to take Xiliarx</p><ul><li>Take Xiliarx every day for as long as your doctor tells you. You may have to take this treatment over a long period of time.</li><li>Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.</li></ul><p>If you take more Xiliarx than you should If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away. Medical attention may be needed. If you need to see a doctor or go to the hospital, take the pack with you.</p><p>If you forget to take Xiliarx If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the usual time. If it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.</p><p>If you stop taking Xiliarx Do not stop taking Xiliarx unless your doctor tells you to. If you have questions about how long to take this medicine, talk to 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>Some symptoms need immediate medical attention: You should stop taking Xiliarx and see your doctor immediately if you experience the following side effects:</p><ul><li>Angioedema (rare: may affect up to 1 in 1 000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called angioedema .</li><li>Liver disease (hepatitis) (frequency not known): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).</li><li>Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1 000 people): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.</li></ul><p>Other side effects</p><p>Some patients have had the following side effects while taking Xiliarx alone:</p><ul><li>Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever.</li><li>Common (may affect up to 1 in 10 people): itchy rash, trembling, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, pain in and around the stomach (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.</li><li>Uncommon (may affect up to 1 in 100 people): weight increase, chills, weakness, sexual dysfunction, low blood glucose, flatulence.</li><li>Rare (may affect up to 1 in 1 000 people): inflammation of the pancreas.</li></ul><p>Since this product has been marketed, the following side effects have also been reported:</p><ul><li>Frequency not known (cannot be estimated from the available data): localised peeling of skin or blisters, blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.</li></ul><p>Reporting of side effects 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\"><ul><li>Keep this medicine out of the sight and reach of children.</li><li>Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP . The expiry date refers to the last day of that month.</li><li>Store in the original package in order to protect from moisture.</li><li>Do not use any Xiliarx pack that is damaged or shows signs of tampering.</li><li>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.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Xiliarx contains</p><ul><li>The active substance is vildagliptin. Each tablet contains 50 mg vildagliptin.</li><li>The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.</li></ul><p>What Xiliarx looks like and contents of the pack Xiliarx 50 mg tablets are round, white to light yellowish and flat, with NVR on one side and FB<br/>on the other.</p><p>Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.</p><p>Not all pack sizes may be marketed in your country.</p><p>Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland</p><p>Manufacturer Lek d.d. Verovskova ulica Ljubljana 1Slovenia</p><p>Novartis Farmac utica S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain</p><p>Novartis Pharma GmbH Roonstrasse D-90429 Nuremberg Germany</p><p>Novartis Pharmaceutical Manufacturing LLC Verovskova ulica Ljubljana 1Slovenia</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16<br/>Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0</p><p>Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20<br/>Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Laboratorios Gebro Pharma, S.A. Tel: +34 93 205 86 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Laborat rio Normal Produtos Farmac uticos Lda. Tel. +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133<br/>Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in</p><p>Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a></p></div>"
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{
"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.
