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-1f87461293bc326acebf2dcaabf7857f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-1f87461293bc326acebf2dcaabf7857f</b></p><a name=\"composition-en-1f87461293bc326acebf2dcaabf7857f\"> </a><a name=\"hccomposition-en-1f87461293bc326acebf2dcaabf7857f\"> </a><a name=\"composition-en-1f87461293bc326acebf2dcaabf7857f-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/1/20/1496/001</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 - oxlumo</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 Oxlumo is and what it is used for</li><li>What you need to know before you are given Oxlumo</li><li>How Oxlumo is given</li><li>Possible side effects</li><li>How to store Oxlumo</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What oxlumo is and what it is used for",
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"text" : "1. What oxlumo is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Oxlumo is</p><p>Oxlumo contains the active substance lumasiran.</p><p>What Oxlumo is used for</p><p>Oxlumo is used to treat primary hyperoxaluria type 1 (PH1) in adults and children of all ages.</p><p>What PH1 is</p><p>PH1 is a rare illness in which the liver produces too much of a substance called oxalate. Your kidneys remove oxalate from the body and it is passed out in the urine. In people with PH1, the extra oxalate can build up in the kidneys and cause kidney stones, and can stop the kidney from working as well as they should. A build-up of oxalate can also damage other parts of the body such as eyes, heart, skin, and bone. This is called oxalosis.</p><p>How Oxlumo works</p><p>Lumasiran, the active substance in Oxlumo, reduces the amount of an enzyme called glycolate oxidase that the liver makes. Glycolate oxidase is one of the enzymes involved in producing oxalate. By lowering the amount of the enzyme, the liver produces less oxalate and the levels of oxalate in the urine and blood also fall. This can help to reduce the effects of the illness.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>You must not be given Oxlumo:</p><ul><li>if you are severely allergic to lumasiran, or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions</p><p>Talk to your doctor before being given this medicine.</p><p>Your doctor may monitor you for signs of metabolic acidosis (the build-up of acid in the body) if you have severe renal impairment.</p><p>Other medicines and Oxlumo</p><p>Tell your doctor if you are using, have recently used, or might use any other medicines.</p><p>Pregnancy</p><p>If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine. Your doctor will decide whether you should take Oxlumo after considering the expected health benefits for you as well as the risks to your unborn baby.</p><p>Breast-feeding</p><p>This medicine may pass into breast milk and it could have an effect on your baby. If you are breast-feeding, ask your doctor for advice before taking this medicine. Your doctor will help you decide whether to stop breast-feeding or to stop treatment.</p><p>Driving and using machines</p><p>This medicine is unlikely to have any effect on your ability to drive or use machines.</p><p>Oxlumo contains sodium</p><p>This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially sodium-free .</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>How much Oxlumo is given</p><p>Your doctor will work out how much medicine to give you. The dose will depend on how much you weigh. Your doctor will adjust your dose as your weight changes.</p><p>You will receive your first doses (loading doses) once a month for 3 doses. You will then start maintenance dosing beginning one month after the last loading dose.</p><p>Body weight less than 10 kg</p><ul><li>Loading doses: 6 mg for every kg of your weight, given once a month for 3 doses.</li><li>Maintenance dosing: 3 mg for every kg of your weight, given once every month beginning one month after the last loading dose.</li></ul><p>Body weight from 10 kg to less than 20 kg</p><ul><li>Loading doses: 6 mg for every kg of your weight, given once a month for 3 doses.</li><li>Maintenance dosing: 6 mg for every kg of your weight, given once every 3 months beginning one month after the last loading dose.</li></ul><p>Body weight 20 kg or more</p><ul><li>Loading doses: 3 mg for every kg of your weight, given once a month for 3 doses.</li><li>Maintenance dosing: 3 mg for every kg of your weight, given once every 3 months beginning one month after the last loading dose.</li></ul><p>How Oxlumo is given</p><p>This medicine will be given to you by a doctor or nurse.</p><ul><li>It is given as an injection under the skin (subcutaneously) into your stomach area (abdomen), or in some cases, your upper arm or thigh. You will be given the injection in a different spot from one injection to the next.</li><li>Depending on your dose, more than one subcutaneous injection may need to be given.</li><li>Your doctor or nurse will not inject into skin areas that are scarred, reddened, inflamed, or swollen.</li></ul><p>If you are given too much Oxlumo</p><p>In the unlikely event that your doctor or nurse gives you too much (an overdose) they will check you for side effects.</p><p>If you miss your dose of Oxlumo</p><p>If you miss a dose of Oxlumo, talk to your doctor or nurse as soon as possible about when to get your next dose.</p><p>If you have any further questions on the use of this medicine, ask your doctor or nurse.</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 side effects may occur when taking Oxlumo:</p><p>Very common: may affect more than 1 in 10 people</p><ul><li>Redness, pain, itching, swelling, discomfort, colour changes, mass, induration, rash, bruising or exfoliation at the site of the injection (injection site reaction).</li><li>Stomach pain or discomfort (abdominal pain)</li></ul><p>Reporting of side effects</p><p>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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"title" : "5. How to store oxlumo",
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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 vial after EXP. The expiry date refers to the last day of that month.</p><p>This medicine is for single use only. Once the vial is opened, use immediately.</p><p>Do not store above 30 C.</p><p>Keep vial in the outer carton to protect from light.</p><p>Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicines that are no longer being used. 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 Oxlumo contains</p><ul><li>The active substance is lumasiran.</li><li>Each vial contains lumasiran sodium equivalent to 94.5 mg lumasiran.</li><li>The other ingredients are water for injections, sodium hydroxide, and phosphoric acid (see Oxlumo contains sodium in section 2).</li></ul><p>What Oxlumo looks like and contents of the pack</p><p>This medicine is a clear, colourless-to-yellow solution for subcutaneous injection.</p><p>Each pack contains one single use vial containing 0.5 mL solution.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Alnylam Netherlands B.V. Antonio Vivaldistraat 1083 HP Amsterdam<br/>Netherlands</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Alnylam Netherlands B.V. T l/Tel: 0800 81 443 (+32 234 208 71) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Malta Genesis Pharma (Cyprus) Ltd Tel: +357 <a href=\"mailto:22765medinfo@genesispharmagroup.com\">22765medinfo@genesispharmagroup.com</a></p><p>Genesis Pharma Bulgaria EOOD Te .: +359 2 969 <a href=\"mailto:3medinfo@genesispharmagroup.com\">3medinfo@genesispharmagroup.com</a></p><p>Nederland Alnylam Netherlands B.V. Tel: 08002820025 (+31 203697861) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>esk republika Alnylam Czech s.r.o. Tel: 800 050 450 (+420 234 092 195) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Norge Alnylam Sweden AB Tlf: 800 544 00 (+472 1405 657) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Danmark Alnylam Sweden AB Tlf: 433 105 15 (+45 787 453 01) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>sterreich Alnylam Austria GmbH Tel: 0800070339 (+43 720 778 072) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Deutschland Portugal Alnylam Germany GmbH Tel: 08002569526 (+49 8920190112) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Alnylam Portugal Tel: 707201512 (+351 707502642) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><pre><code> . </code></pre><p>: +30 210 87 71 <a href=\"mailto:medinfo@genesispharmagroup.com\">medinfo@genesispharmagroup.com</a></p><p>Rom nia Genesis Biopharma Romania SRL Tel: +40 21 403 <a href=\"mailto:4medinfo@genesispharmagroup.com\">4medinfo@genesispharmagroup.com</a></p><p>Espa a Alnylam Pharmaceuticals Spain SL Tel: 900810212 (+34 910603753) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Slovenija Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 <a href=\"mailto:medinfo@genesispharmagroup.com\">medinfo@genesispharmagroup.com</a></p><p>France Alnylam France SAS T l: 0805542656 (+33 187650921) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Suomi/Finland Alnylam Sweden AB Puh/Tel: 0800 417 452 (+358 942 727 020) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Hrvatska Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 <a href=\"mailto:medinfo@genesispharmagroup.com\">medinfo@genesispharmagroup.com</a></p><p>Sverige Alnylam Sweden AB Tel: 020109162 (+46 842002641) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Italia Alnylam Italy S.r.l. Tel: 800 90 25 37 (+39 02 89 73 22 91) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>United Kingdom (Northern Ireland) Alnylam UK Ltd. Tel: 08001412569 (+44 1628 878592) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Ireland Alnylam Netherlands B.V. Tel: 1800 924260 (+353 818 882213) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>Eesti, sland, Latvija, Lietuva, Magyarorsz g, Polska, Slovensk republika Alnylam Netherlands B.V. Tel/S mi: +31 20 369 <a href=\"mailto:7medinfo@alnylam.com\">7medinfo@alnylam.com</a></p><p>Genesis Pharma (Cyprus) Ltd : +357 <a href=\"mailto:22765medinfo@genesispharmagroup.com\">22765medinfo@genesispharmagroup.com</a></p><p>Luxembourg/Luxemburg Alnylam Netherlands B.V. T l/Tel: 80085235 (+352 203 014 48) <a href=\"mailto:medinfo@alnylam.com\">medinfo@alnylam.com</a></p><p>This leaflet was last revised in .</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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"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.
