FHIR IG analytics| Package | hl7.fhir.uv.emedicinal-product-info |
| Resource Type | Composition |
| Id | Composition-composition-epi-type3-example-wonderdrug.json |
| FHIR Version | R5 |
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WonderDrug Summary of Product Characteristics
FHIR
FHIRsmith{
"resourceType": "Composition",
"id": "composition-epi-type3-example-wonderdrug",
"meta": {
"versionId": "1",
"lastUpdated": "2023-10-27T10:00:00Z",
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language": "en",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "composition-epi-type3-example-wonderdrug"
}
],
"version": "1.0",
"status": "final",
"type": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "100000155532",
"display": "Summary of Product Characteristics"
}
]
},
"subject": [
{
"reference": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"
}
],
"date": "2023-10-27",
"author": [
{
"reference": "Organization/org-epi-type3-example-pharma"
}
],
"title": "WonderDrug 500 mg tablets - Summary of Product Characteristics",
"section": [
{
"title": "SUMMARY OF PRODUCT CHARACTERISTICS",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029791",
"display": "SUMMARY OF PRODUCT CHARACTERISTICS"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Summary of Product Characteristics for WonderDrug</div>"
},
"section": [
{
"title": "1. NAME OF THE MEDICINAL PRODUCT",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029792",
"display": "1. NAME OF THE MEDICINAL PRODUCT"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderDrug 500 mg tablets</p></div>"
}
},
{
"title": "2. QUALITATIVE AND QUANTITATIVE COMPOSITION",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029793",
"display": "2. QUALITATIVE AND QUANTITATIVE COMPOSITION"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg of paracetamol.</p></div>"
},
"section": [
{
"title": "2.1 General description",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029794",
"display": "2.1 General description"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>White, round, biconvex tablets.</p></div>"
}
},
{
"title": "2.2 Qualitative and quantitative composition",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029795",
"display": "2.2 Qualitative and quantitative composition"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg paracetamol.</p></div>"
}
},
{
"title": "Excipient(s) with known effect",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029796",
"display": "Excipient(s) with known effect"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>For the full list of excipients, see section 6.1.</p></div>"
}
}
]
},
{
"title": "3. PHARMACEUTICAL FORM",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029797",
"display": "3. PHARMACEUTICAL FORM"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Tablet. White, round, biconvex tablets.</p></div>"
}
},
{
"title": "4. CLINICAL PARTICULARS",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029798",
"display": "4. CLINICAL PARTICULARS"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Clinical information about WonderDrug.</p></div>"
},
"section": [
{
"title": "4.1 Therapeutic indications",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029799",
"display": "4.1 Therapeutic indications"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Symptomatic treatment of mild to moderate pain and/or fever.</p></div>"
}
},
{
"title": "4.2 Posology and method of administration",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029800",
"display": "4.2 Posology and method of administration"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Adults: 1-2 tablets every 4-6 hours. Maximum 8 tablets in 24 hours.</p></div>"
}
},
{
"title": "4.3 Contraindications",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029805",
"display": "4.3 Contraindications"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Hypersensitivity to paracetamol or any of the excipients.</p></div>"
}
},
{
"title": "4.4 Special warnings and precautions for use",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029806",
"display": "4.4 Special warnings and precautions for use"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Caution in patients with hepatic or renal impairment.</p></div>"
}
},
{
"title": "4.5 Interaction with other medicinal products and other forms of interaction",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029809",
"display": "4.5 Interaction with other medicinal products and other forms of interaction"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Anticoagulants: Enhanced effect of warfarin with prolonged use.</p></div>"
}
},
{
"title": "4.6 Fertility, pregnancy and lactation",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029811",
"display": "4.6 Fertility, pregnancy and lactation"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Can be used during pregnancy and lactation at recommended doses.</p></div>"
}
},
{
"title": "4.7 Effects on ability to drive and use machines",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029815",
"display": "4.7 Effects on ability to drive and use machines"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No known effect.</p></div>"
}
},
{
"title": "4.8 Undesirable effects",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029816",
"display": "4.8 Undesirable effects"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris.</p><p><b>Summary of adverse reactions:</b></p><ul><li>Very common (≥1/10): Nausea, headache</li><li>Common (≥1/100 to <1/10): Dizziness, fatigue</li><li>Uncommon (≥1/1,000 to <1/100): Allergic reactions, skin rash</li><li>Rare (≥1/10,000 to <1/1,000): Hepatotoxicity</li></ul><table border=\"1\"><tr><th>System Organ Class</th><th>Frequency</th><th>Adverse Reaction</th></tr><tr><td>Gastrointestinal</td><td>Very common</td><td>Nausea</td></tr><tr><td>Nervous system</td><td>Very common</td><td>Headache</td></tr><tr><td>Skin</td><td>Uncommon</td><td>Rash, pruritus</td></tr></table><p>Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.</p><p><img src=\"data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48Y2lyY2xlIGN4PSI1MCIgY3k9IjUwIiByPSI0MCIgc3Ryb2tlPSJibGFjayIgc3Ryb2tlLXdpZHRoPSIzIiBmaWxsPSJyZWQiIC8+PC9zdmc+\" alt=\"Sample SVG Image\"/></p></div>"
}
},
{
"title": "4.9 Overdose",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029819",
"display": "4.9 Overdose"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Symptoms: Hepatic damage. Treatment: N-acetylcysteine.</p></div>"
}
}
]
},
{
"title": "5. PHARMACOLOGICAL PROPERTIES",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029821",
"display": "5. PHARMACOLOGICAL PROPERTIES"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacological properties of WonderDrug.</p></div>"
},
"section": [
{
"title": "5.1 Pharmacodynamic properties",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029822",
"display": "5.1 Pharmacodynamic properties"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacotherapeutic group: Analgesics, ATC code: N02BE01.</p></div>"
}
},
{
"title": "5.2 Pharmacokinetic properties",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029827",
"display": "5.2 Pharmacokinetic properties"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Rapidly absorbed from the GI tract. Peak plasma concentration in 30-60 minutes.</p></div>"
}
},
{
"title": "5.3 Preclinical safety data",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029834",
"display": "5.3 Preclinical safety data"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No additional data of relevance.</p></div>"
}
}
]
},
{
"title": "6. PHARMACEUTICAL PARTICULARS",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029836",
"display": "6. PHARMACEUTICAL PARTICULARS"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmaceutical particulars for WonderDrug.</p></div>"
},
"section": [
{
"title": "6.1 List of excipients",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029837",
"display": "6.1 List of excipients"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pregelatinised starch, maize starch, magnesium stearate.</p></div>"
}
},
{
"title": "6.2 Incompatibilities",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029838",
"display": "6.2 Incompatibilities"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Not applicable.</p></div>"
}
},
{
"title": "6.3 Shelf life",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029839",
"display": "6.3 Shelf life"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>3 years.</p></div>"
}
},
{
"title": "6.4 Special precautions for storage",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029840",
"display": "6.4 Special precautions for storage"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Store below 25°C.</p></div>"
}
},
{
"title": "6.5 Nature and contents of container",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029841",
"display": "6.5 Nature and contents of container"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>PVC/Aluminium blisters. Pack sizes: 10, 20, 30 tablets.</p></div>"
}
},
{
"title": "6.6 Special precautions for disposal",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029842",
"display": "6.6 Special precautions for disposal"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No special requirements.</p></div>"
}
}
]
},
{
"title": "7. MARKETING AUTHORISATION HOLDER",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029844",
"display": "7. MARKETING AUTHORISATION HOLDER"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderPharma Inc., 123 Pharma Way, Prague, Czech Republic</p></div>"
}
},
{
"title": "8. MARKETING AUTHORISATION NUMBER(S)",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029845",
"display": "8. MARKETING AUTHORISATION NUMBER(S)"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>EU/1/23/1234/001</p></div>"
}
},
{
"title": "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029846",
"display": "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Date of first authorisation: 15 January 2020</p></div>"
}
},
{
"title": "10. DATE OF REVISION OF THE TEXT",
"code": {
"coding": [
{
"system": "https://spor.ema.europa.eu/rmswi",
"code": "200000029847",
"display": "10. DATE OF REVISION OF THE TEXT"
}
]
},
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>October 2023</p></div>"
}
}
]
}
]
}