Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build
Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build
Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
{
"resourceType" : "Composition",
"id" : "cfsb1651231019151",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b></p><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\">Resource Composition \"cfsb1651231019151\" (Language \"en\") </p></div><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2022-04-29 01:28:17+0000</p><p><b>author</b>: <a href=\"Organization-cfsb1651149636159.html\">Organization/cfsb1651149636159</a> \"ViiV Healthcare BV\"</p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><p><b>confidentiality</b>: U</p><h3>Attesters</h3><table class=\"grid\"><tr><td>-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td>*</td><td>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-composition-attestation-mode.html\">CompositionAttestationMode</a>#official)</span></td><td>2002-08-01 01:28:17+0000</td></tr></table></div>"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538"
}
],
"text" : "Package Leaflet"
},
"subject" : {
"reference" : "RegulatedAuthorization/cfsb1651148079894"
},
"date" : "2022-04-29T13:28:17Z",
"author" : [
{
"reference" : "Organization/cfsb1651149636159"
}
],
"title" : "TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets",
"confidentiality" : "U",
"attester" : [
{
"mode" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/composition-attestation-mode",
"code" : "official"
}
]
},
"time" : "2002-08-01T13:28:17Z"
}
],
"section" : [
{
"title" : "B. Package Leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.<ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>"
}
},
{
"title" : "What is in this leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-0"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">What in this leaflet<ol><li>What Dovato is and what it is used for</li><li>What you need to know before you take Dovato</li><li>How to take Dovato</li><li>Possible side effects</li><li>How to store Dovato</li><li>Contents of the pack and other information</li></ol></div>"
}
},
{
"title" : "1. What Dovato is and what it is used for",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-1"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>1. What Dovato is and what it is used for</b> Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.</div>"
}
},
{
"title" : "2. What you need to know before you take Dovato",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-2"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>2. What you need to know before you take Dovato</b> Do not take Dovato<ul><li>if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).</li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>"
}
},
{
"title" : "3. How to take Dovato",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-3"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>How to take Dovato</b><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure</p><ul><li>The recommended dose of Dovato is <b>one tablet once a day.</b></li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>"
}
},
{
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-4"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>4. Possible side effects</b></p><p>Like all medicines, this medicine can cause side effects, although not everybody gets them,<b>so it is very important to talk to your doctor about any changes in your health</b></p></div>"
}
},
{
"title" : "5. How to store Dovato",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-5"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>5. How to store Dovato</b><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 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>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>"
}
},
{
"title" : "6. Contents of the pack and other information",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/",
"code" : "100000155538-6"
}
],
"text" : "B. PACKAGE LEAFLET"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>6. Contents of the pack and other information</b> <b>What Dovato contains</b><ul><li>The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.</li><li>The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).</li><li>This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.</li></ul></div>"
}
}
]
}
IG © 2021+ . Package hl7.fhir.uv.vulcan-epi#0.1.0 based on FHIR 5.0.0-snapshot1. Generated 2022-09-02
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change