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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-4c464411361072df4cc109cbbcdd523e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="None"/>
</identifier>
<type value="document"/>
<timestamp value="2023-06-27T10:09:22Z"/>
<entry>
<fullUrl
value="Composition/composition-en-4c464411361072df4cc109cbbcdd523e"/>
<resource>
<Composition>
<id value="composition-en-4c464411361072df4cc109cbbcdd523e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-4c464411361072df4cc109cbbcdd523e"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-4c464411361072df4cc109cbbcdd523e</b></p><a name="composition-en-4c464411361072df4cc109cbbcdd523e"> </a><a name="hccomposition-en-4c464411361072df4cc109cbbcdd523e"> </a><a name="composition-en-4c464411361072df4cc109cbbcdd523e-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/1/19/1408/001</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 - sunosi</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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/19/1408/001"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<category>
<coding>
<system
value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
<code value="R"/>
<display value="Raw"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mp4c464411361072df4cc109cbbcdd523e"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - sunosi"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2022-02-16T13:28:17Z"/>
</attester>
<section>
<title value="B. Package Leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="B. Package Leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="Package leaflet: Information for the user"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package leaflet: Information for the user"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Sunosi is and what it is used for</li><li>What you need to know before you take Sunosi</li><li>How to take Sunosi</li><li>Possible side effects</li><li>How to store Sunosi</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What sunosi is and what it is used for"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What sunosi is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Sunosi contains the active substance solriamfetol. Solriamfetol increases the amount of the natural substances dopamine and norepinephrine in your brain. Sunosi helps you to stay awake and to feel less sleepy.</p><p>It is used</p><ul><li><p>in adults with narcolepsy, a condition that causes you to suddenly and unexpectedly feel very sleepy at any time. Some patients with narcolepsy also have symptoms of cataplexy (when muscles become weak in response to emotions such as anger, fear, laughter or surprise, sometimes leading to collapse).</p></li><li><p>to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).</p></li></ul></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take sunosi"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="2. What you need to know before you take sunosi"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Sunosi if you:</p><ul><li><p>are allergic to solriamfetol or any of the other ingredients of this medicine (listed in section 6)</p></li><li><p>had a heart attack in the past 1 year</p></li><li><p>have serious heart problems, such as chest pain of recent onset, or chest pain that is lasting longer or is more severe than usual, high blood pressure not properly controlled with medicines, serious irregular heart beat or other serious heart problems</p></li><li><p>are taking a type of medicine called a monoamine oxidase inhibitor (MAOI) for depression or Parkinson s disease, or have taken an MAOI in the last 14 days. Warnings and precautions Talk to your doctor or pharmacist before taking Sunosi if you have or have had:</p></li><li><p>mental health problems, including psychosis (altered sense of what is real) and extreme changes in mood (bipolar disorder)</p></li><li><p>heart problems, heart attack or stroke</p></li><li><p>high blood pressure</p></li><li><p>alcoholism or any drug abuse or dependence</p></li><li><p>an eye condition called angle closure glaucoma.</p></li></ul><p>Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Sunosi may make some of these problems worse. Your doctor will want to monitor how the medicine affects you.</p><p>Sunosi does not replace your OSA primary treatment such as CPAP. You should continue to use such treatment as well as Sunosi.</p><p>Children and adolescents Sunosi is not recommended in children or adolescents under 18 years of age. The safety and efficacy are not yet known in this age group.</p><p>Other medicines and Sunosi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Do not take Sunosi if:</p><ul><li>you are taking a medicine called a monoamine oxidase inhibitor (MAOI) for depression or Parkinson s disease, or have taken an MAOI in the last 14 days because taking an MAOI with Sunosi may increase your blood pressure.</li></ul><p>Check with your doctor or pharmacist if you are taking medicines that can increase your blood pressure or heart rate, or if you are taking dopaminergic agents (e.g. pramipexole, levodopa, methylphenidate) which are used to treat Parkinson s disease, depression, restless leg syndrome and ADHD.</p><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>Sunosi should not be used during pregnancy or in women of childbearing potential not using effective contraception.</p><p>You should not use Sunosi during breast-feeding. You and your doctor must decide whether to avoid breast-feeding or to stop or avoid Sunosi therapy, taking into account the benefit of breast-feeding for you and your child and the benefit of therapy for you.</p><p>Driving and using machines You may feel dizzy or your ability to concentrate may be impaired; take special care when driving or using machines.</p><p>Talk to your doctor or pharmacist if you are not sure how your underlying condition or this medicine affects you with activities that require attention, such as driving and handling machinery:</p><ul><li>at the beginning of treatment</li><li>if your dose is changed</li></ul></div>
</text>
</section>
<section>
<title value="3. How to take sunosi"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take sunosi"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>How much Sunosi to take Your doctor will advise you on the dose of Sunosi to take.</p><ul><li><p>For narcolepsy, treatment is normally started with a dose of 75 mg once per day, in the morning when you wake up. Some patients may need a 150-mg starting dose. Your doctor will advise you if this applies to you. Your doctor may prescribe you a lower dose of 37.5 mg. You can get this dose by taking half of one 75 mg tablet. The tablet should be broken using the score line.</p></li><li><p>For OSA, treatment is normally started with a dose of 37.5 mg once per day, in the morning when you wake up. You can get this dose by taking half of one 75 mg tablet. The tablet should be broken using the score line.</p></li><li><p>After at least 3 days treatment, your doctor may increase your daily dose to the most appropriate dose.</p></li></ul><p>The recommended maximum dose of Sunosi is 150 mg daily.</p><p>Elderly (aged more than 65 years) Take the usual daily dose unless you have kidney problems (see below Patients with kidney problems ).</p><p>Patients with kidney problems If you have kidney problems your doctor may need to adjust the dose.</p><p>Taking Sunosi</p><ul><li>Sunosi is for oral use</li><li>Take Sunosi by mouth in the morning when you wake up.</li><li>You can take Sunosi with food or between meals.</li></ul><p>How long to take Sunosi You should continue to take Sunosi for as long as you are told to by your doctor.</p><p>If you take more Sunosi than you should The following symptoms were observed when patients received Sunosi 900mg (6 times the maximum daily dose): uncontrollable movements (tardive dyskinesia) and feeling restless and unable to keep still (akathisia). These symptoms resolved when Sunosi was stopped.</p><p>Contact your doctor or nearest emergency department immediately for advice. Take this leaflet and any remaining tablets with you.</p><p>If you forget to take Sunosi If you forget to take your medicine at the usual time, you can still take it if it is more than 9 hours before bedtime. Do not take a double dose to make up for a forgotten dose.</p><p>If you stop taking Sunosi Discuss with your doctor before you stop taking Sunosi.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="4. Possible side effects"/>
</code>
<text>
<status value="additional"/>
<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>Very common side effects (may affect more than 1 in 10 people)</p><ul><li>Headache</li></ul><p>Common side effects (may affect up to 1 in 10 people)</p><ul><li>Anxiety, difficulty sleeping, irritability, dizziness, feeling jittery, excessive sweating</li><li>Fast or irregular heart beats, also called palpitations, chest discomfort</li><li>High blood pressure</li><li>Feeling sick, diarrhoea, stomach pain, constipation, vomiting</li><li>Cough, clenching or grinding your teeth, dry mouth</li><li>Loss of appetite</li></ul><p>Uncommon side effects (may affect up to 1 in 100 people)</p><ul><li>Feeling agitated, restlessness, inability to concentrate, shaking (tremors)</li><li>Increase in heart rate much higher than normal</li><li>Shortness of breath</li><li>Chest pain</li><li>Thirst</li><li>Weight loss</li></ul><p>Skin rash, hives and itching have also been reported.</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>
</text>
</section>
<section>
<title value="5. How to store sunosi"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store sunosi"/>
</code>
<text>
<status value="additional"/>
<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 bottle / blister after EXP . The expiry date refers to the last day of that month.</p><p>Blisters: This medicine does not require any special storage conditions.</p><p>Bottles: Once opened, use within 4 months. Keep the container tightly closed in order to protect from moisture.</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>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="6. Contents of the pack and other information"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What Sunosi contains The active substance is solriamfetol.</p><p>Sunosi 75 mg film-coated tablets Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol.</p><p>Sunosi 150 mg film-coated tablets Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol.</p><p>The other ingredients are: Tablet cores: Hydroxypropyl cellulose, magnesium stearate</p><p>Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172).</p><p>What Sunosi looks like and contents of the pack Film-coated tablet</p><p>Sunosi 75 mg film-coated tablets Yellow to dark yellow/orange oblong tablet with 75 debossed on one side and a score line on the opposite side. The tablet can be divided into equal doses.</p><p>Sunosi 150 mg film-coated tablets<br/>Yellow oblong tablet with 150 debossed on one side.</p><p>Sunosi is available in blister packs of 7 x 1 film-coated tablets in PVC/PCTFE/Aluminium perforated unit dose blisters, 28 and 56 film-coated tablets and in bottles of 30 and 100 film-coated tablets.</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Marketing Authorisation Holder Atnahs Pharma Netherlands B. V. Copenhagen Towers restads Boulevard 108, 5.tv DK-2300 K benhavn S Denmark</p><p>Manufacturer Cilatus Manufacturing Services Limited<br/>Pembroke House 28-32 Pembroke Street Upper Dublin 2 Co. Dublin D02 EKIreland</p><p>This leaflet was last revised in MM/YYYY.</p><p>Other sources of information Detailed information on this medicine is available on the European Medicines Agency website:<br/><a href="http://www.ema.europa.eu">http://www.ema.europa.eu</a>.</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp4c464411361072df4cc109cbbcdd523e"/>
<resource>
<MedicinalProductDefinition>
<id value="mp4c464411361072df4cc109cbbcdd523e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp4c464411361072df4cc109cbbcdd523e"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp4c464411361072df4cc109cbbcdd523e</b></p><a name="mp4c464411361072df4cc109cbbcdd523e"> </a><a name="hcmp4c464411361072df4cc109cbbcdd523e"> </a><a name="mp4c464411361072df4cc109cbbcdd523e-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/19/1408/001</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Sunosi 75 mg film-coated tablets</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/19/1408/001"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName value="Sunosi 75 mg film-coated tablets"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
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.
