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-1d04d08431237504735e48c47e138afc\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-1d04d08431237504735e48c47e138afc</b></p><a name=\"composition-en-1d04d08431237504735e48c47e138afc\"> </a><a name=\"hccomposition-en-1d04d08431237504735e48c47e138afc\"> </a><a name=\"composition-en-1d04d08431237504735e48c47e138afc-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/1/13/822/001</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 - pheburane</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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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet:</p><ol type=\"1\"><li>What PHEBURANE is and what it is used for</li><li>What you need to know before you take PHEBURANE</li><li>How to take PHEBURANE</li><li>Possible side effects</li><li>How to store PHEBURANE</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What pheburane is and what it is used for",
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"text" : "1. What pheburane is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders. These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.</p><p>Nitrogen is a building block of proteins, which are an essential part of the food we eat. As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.</p><p>This medicine helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body. However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician. You must follow this diet carefully.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take PHEBURANE if you:</p><p>are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).</p><p>are pregnant.</p><p>are breast-feeding.</p><p>Warnings and precautions Talk to your doctor or pharmacist before taking PHEBURANE if you:</p><p>suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.</p><p>have decreased kidney or liver function, since PHEBURANE is eliminated from the body through the kidney and liver. PHEBURANE will not prevent the occurrence of an acute excess of ammonia in the blood, a condition which usually constitutes a medical emergency. If this happens you will develop symptoms such as feeling sick (nausea), being sick (vomiting), confusion and will need to get urgent medical help.</p><p>If you need laboratory tests, it is important to remind your doctor that you are taking PHEBURANE, since sodium phenylbutyrate may interfere with certain laboratory test results (such as blood electrolytes or protein, or liver function tests)</p><p>In case of any doubt, ask your doctor or pharmacist.</p><p>Other medicines and PHEBURANE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>It is especially important to tell your doctor if you are taking medicines containing:</p><p>valproate (an antiepileptic medicine).</p><p>haloperidol (used in certain psychotic disorders).</p><p>corticosteroids (medicines that are used to provide relief for inflamed areas of the body),</p><p>probenecid (for treatment of hyperuricaemia, high levels of uric acid in the blood, associated with gout).</p><p>These medicines may change the effect of PHEBURANE and you will need more frequent blood tests. If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.</p><p>Pregnancy and breast-feeding Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.</p><p>If you are a woman who could get pregnant, you must use reliable contraception, during treatment with PHEBURANE. Talk to your doctor for the details.</p><p>Do not use PHEBURANE if you are breast-feeding, because this medicine can pass into the breast milk and may harm your baby.</p><p>Driving and using machines PHEBURANE is unlikely to affect your ability to drive and use machines.</p><p>PHEBURANE contains sodium and sucrose This medicine contains 124 mg (5.4 mmol) sodium (main component of cooking/table salt) in each gram granules. This is equivalent to 6,2% of the recommended maximum daily dietary intake of sodium for an adult.<br/>The maximum daily dose of this medicine contains 2.5 mg sodium per 20 gram granules. This is equivalent to 125% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more grams daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.</p><p>This medicine contains 768 mg sucrose in each gram granules. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.</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>Dose The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose. Your doctor will tell you the amount of granules you should take.</p><p>Method of administration You should take PHEBURANE by mouth. Because it dissolves slowly, PHEBURANE should not be administered through a gastrostomy (tube that goes through the abdomen to the stomach) or through a nasogastric tube (tube that goes through the nose to the stomach).</p><p>PHEBURANE must be taken with a special diet reduced in protein.</p><p>You should take PHEBURANE with each meal or feeding. In small children this can be 4 to 6 times per day.</p><p>The doses of PHEBURANE prescribed by your doctor are expressed in grams of sodium phenylbutyrate. A calibrated measuring spoon which dispenses up to 3 g of sodium phenylbutyrate at a time is provided with the medicine. Only use this measuring spoon to measure out the dose of PHEBURANE. The measuring spoon must not be used for any other medicine.</p><p>To measure the dose:</p><p>Lines on the spoon indicate the amount of PHEBURANE in gram of sodium phenylbutyrate. Take the correct amount as prescribed by your doctor.</p><p>Pour granules directly into the spoon as shown by the picture (on the outer carton and in this leaflet).</p><p>Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary.</p><p>The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce). If you mix them with food, it is important that you take it immediately. This will keep the granules from producing any taste.</p><p>You will need to take this medicine and to follow a diet throughout your life.</p><p>If you take more PHEBURANE than you should Patients who have taken very high doses of sodium phenylbutyrate experienced:</p><p>sleepiness, tiredness, light-headedness and less frequently confusion;</p><p>headache;</p><p>changes in taste (taste disturbances);</p><p>decrease in hearing;</p><p>disorientation;</p><p>impaired memory;</p><p>worsening of existing neurological conditions.</p><p>If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.</p><p>If you forget to take PHEBURANE You should take a dose as soon as possible with your next meal. Make sure that there are at least 3 hours between two doses. Do not take a double dose to make up for a forgotten dose.</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>If persistent vomiting occurs, you should contact your doctor immediately.</p><p>Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women. If you are sexually active and your period stops altogether, do not assume that this is caused by PHEBURANE. If this occurs, please discuss it with your doctor, because the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above) or by menopause.</p><p>Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odour, rash, abnormal kidney function, weight gain, altered laboratory test values.</p><p>Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.</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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"title" : "5. How to store pheburane",
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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 PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.</p><p>After the first opening, PHEBURANE can be used within 45 days.</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 PHEBURANE contains The active substance is sodium phenylbutyrate. Each gram of granules contains 483 mg of sodium phenylbutyrate. The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25. What PHEBURANE looks like and contents of the pack PHEBURANE granules are white to off-white.</p><p>The granules are packaged in a plastic bottle with child-resistant closure and a dessicant.<br/>Each bottle contains 174g of granules.</p><p>Each carton contains 1 bottle.</p><p>A calibrating measuring spoon is provided.</p><p>Marketing Authorisation Holder<br/>Eurocept International BV Trapgans 5 1244 RL Ankeveen The Netherlands</p><p>Manufacturer Eurocept International BV Trapgans 5 1244 RL Ankeveen The Netherlands</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Lucane Pharma T l/Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Lietuva<br/>FrostPharma AB Tel: +46 775 86 80 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Lucane Pharma Te .: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Luxembourg/Luxemburg Lucane Pharma T l/Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> esk republika Lucane Pharma T l/Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Magyarorsz g Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Danmark FrostPharma AB Tlf: +45 808 20 <a href=\"mailto:info@frostpharma.com\">info@frostpharma.com</a></p><p>Malta Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Deutschland Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Nederland Lucane Pharma (Eurocept International BV) Tel: +31 35 528 39 <a href=\"mailto:info@euroceptpharma.com\">info@euroceptpharma.com</a> Eesti FrostPharma AB Tel: +46 775 86 80 <a href=\"mailto:info@frostpharma.com\">info@frostpharma.com</a> Norge FrostPharma AB Tlf: +47 815 03 <a href=\"mailto:info@frostpharma.com\">info@frostpharma.com</a></p><p>Lucane Pharma : + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>sterreich Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Espa a Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Polska Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> France Lucane Pharma T l: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Portugal Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Hrvatska Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Rom nia Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Ireland Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Slovenija Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> sland Lucane Pharma S mi: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Slovensk republika Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Italia Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a> Suomi/Finland FrostPharma AB Puh/Tel: +35 875 32 51 <a href=\"mailto:info@frostpharma.com\">info@frostpharma.com</a></p><p>Lucane Pharma : + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></p><p>Sverige FrostPharma AB<br/>Tel: +46 775 86 80 <a href=\"mailto:info@medicalneed.com\">info@medicalneed.com</a> Latvija FrostPharma AB Tel: +46 775 86 80 <a href=\"mailto:info@frostpharma.com\">info@frostpharma.com</a> United Kingdom (Northern Ireland) Lucane Pharma Tel: + 33 153 868 <a href=\"mailto:info@lucanepharma.com\">info@lucanepharma.com</a></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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}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "PHEBURANE 483 mg/g granules",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"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.
