FHIR IG analytics| Package | hl7.fhir.uv.emedicinal-product-info |
| Resource Type | Bundle |
| Id | Bundle-bundle-epi-type3-example-diflucan.json |
| FHIR Version | R5 |
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No resources found
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FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "bundle-epi-type3-example-diflucan",
"meta": {
"versionId": "1.0",
"lastUpdated": "2026-06-17T10:00:00Z",
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type3"
]
},
"identifier": {
"system": "http://ema.europa.eu/identifier",
"value": "DIFLUCAN-BUNDLE-TYPE3"
},
"type": "document",
"timestamp": "2026-06-17T10:00:00Z",
"entry": [
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-diflucan",
"resource": {
"resourceType": "Composition",
"id": "composition-diflucan",
"meta": {
"versionId": "1",
"lastUpdated": "2026-06-17T10:00:00Z",
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language": "en",
"text": {
"status": "generated",
"div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_composition-diflucan\"> </a><p>Diflucan Summary of Product Characteristics</p></div>"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "composition-diflucan"
}
],
"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-diflucan"
}
],
"date": "2026-06-17",
"author": [
{
"reference": "Organization/org-diflucan"
}
],
"title": "Diflucan 150 mg capsule - Summary of Product Characteristics",
"section": [
{
"id": "diflucan-root",
"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 Diflucan</div>"
},
"section": [
{
"id": "diflucan-4-1",
"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>Treatment of mucosal and invasive candidiasis.</p></div>"
},
"entry": [
{
"reference": "ClinicalUseDefinition/cud-diflucan-mucosal"
},
{
"reference": "ClinicalUseDefinition/cud-diflucan-invasive"
}
]
},
{
"id": "diflucan-4-2",
"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>Dose depends on the indication and the patient population (see structured dosing). Renal impairment requires dose adjustment for multiple-dose therapy.</p></div>"
},
"entry": [
{
"reference": "MedicationKnowledge/mk-diflucan"
},
{
"reference": "ClinicalUseDefinition/cud-diflucan-renal"
}
]
}
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-diflucan",
"resource": {
"resourceType": "Organization",
"id": "org-diflucan",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_org-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization org-diflucan</b></p><a name=\"org-diflucan\"> </a><a name=\"hcorg-diflucan\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000999</p><p><b>active</b>: true</p><p><b>name</b>: Example Pharma Ltd.</p></div>"
},
"identifier": [
{
"system": "https://spor.ema.europa.eu/omswi",
"value": "LOC-100000999"
}
],
"active": true,
"name": "Example Pharma Ltd."
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-diflucan",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpd-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd-diflucan</b></p><a name=\"mpd-diflucan\"> </a><a name=\"hcmpd-diflucan\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/DIFLUCAN-150MG</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductName</b></td></tr><tr><td style=\"display: none\">*</td><td>Diflucan 150 mg capsule</td></tr></table></div>"
},
"identifier": [
{
"system": "http://ema.europa.eu/identifier",
"value": "DIFLUCAN-150MG"
}
],
"status": {
"coding": [
{
"system": "http://hl7.org/fhir/publication-status",
"code": "active",
"display": "Active"
}
]
},
"name": [
{
"productName": "Diflucan 150 mg capsule"
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/mk-diflucan",
"resource": {
"resourceType": "MedicationKnowledge",
"id": "mk-diflucan",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicationKnowledge-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicationKnowledge_mk-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicationKnowledge mk-diflucan</b></p><a name=\"mk-diflucan\"> </a><a name=\"hcmk-diflucan\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicationKnowledge-uv-epi.html\">MedicationKnowledge (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/mk-diflucan</p><p><b>status</b>: Active</p><blockquote><p><b>indicationGuideline</b></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ClinicalUseDefinition-cud-diflucan-mucosal.html\">ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-mucosal; type = indication; category = Indication; status = Active</a></td></tr></table><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Loading dose (Day 1)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 200 to 400 mg on Day 1</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>200-400 mg</td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Maintenance</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 100 to 200 mg once daily for 7 to 21 days</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>100-200 mg</td></tr></table></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>18-? years</td></tr></table></blockquote><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Initial dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 6 mg/kg on the first day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>6 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Subsequent dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 3 mg/kg once daily</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>28-11 days</td></tr></table></blockquote><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Neonatal dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)</p><p><b>timing</b>: Once per 72 hours</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table><p><b>maxDosePerPeriod</b>: 12 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span>/72 hours<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeh = 'h')</span></p></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>0-14 days</td></tr></table></blockquote></blockquote><blockquote><p><b>indicationGuideline</b></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ClinicalUseDefinition-cud-diflucan-invasive.html\">ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-invasive; type = indication; category = Indication; status = Active</a></td></tr></table><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Loading dose (Day 1)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 800 mg on Day 1</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>800 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Maintenance</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 400 mg once daily</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>400 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td></tr></table></blockquote></blockquote></blockquote></blockquote></div>"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "mk-diflucan"
}
],
"status": "active",
"indicationGuideline": [
{
"indication": [
{
"reference": {
"reference": "ClinicalUseDefinition/cud-diflucan-mucosal"
}
}
],
"dosingGuideline": [
{
"dosage": [
{
"type": {
"text": "Loading dose (Day 1)"
},
"dosage": [
{
"sequence": 1,
"text": "200 to 400 mg on Day 1",
"doseAndRate": [
{
"doseRange": {
"low": {
"value": 200,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
},
"high": {
"value": 400,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
}
}
}
]
}
]
},
{
"type": {
"text": "Maintenance"
},
"dosage": [
{
"sequence": 2,
"text": "100 to 200 mg once daily for 7 to 21 days",
"timing": {
"repeat": {
"frequency": 1,
"period": 1,
"periodUnit": "d"
}
},
"doseAndRate": [
{
"doseRange": {
"low": {
"value": 100,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
},
"high": {
"value": 200,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
}
}
}
]
}
]
}
],
"patientCharacteristic": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code": "age",
"display": "Age"
}
]
},
"valueRange": {
"low": {
"value": 18,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
}
}
}
]
},
{
"dosage": [
{
"type": {
"text": "Initial dose"
},
"dosage": [
{
"sequence": 1,
"text": "6 mg/kg on the first day",
"doseAndRate": [
{
"doseQuantity": {
"value": 6,
"unit": "mg/kg",
"system": "http://unitsofmeasure.org",
"code": "mg/kg"
}
}
]
}
]
},
{
"type": {
"text": "Subsequent dose"
},
"dosage": [
{
"sequence": 2,
"text": "3 mg/kg once daily",
"timing": {
"repeat": {
"frequency": 1,
"period": 1,
"periodUnit": "d"
}
},
"doseAndRate": [
{
"doseQuantity": {
"value": 3,
"unit": "mg/kg",
"system": "http://unitsofmeasure.org",
"code": "mg/kg"
}
}
]
}
]
}
],
"patientCharacteristic": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code": "age",
"display": "Age"
}
]
},
"valueRange": {
"low": {
"value": 28,
"unit": "days",
"system": "http://unitsofmeasure.org",
"code": "d"
},
"high": {
"value": 11,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
}
}
}
]
},
{
"dosage": [
{
"type": {
"text": "Neonatal dose"
},
"dosage": [
{
"sequence": 1,
"text": "3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)",
"timing": {
"repeat": {
"frequency": 1,
"period": 72,
"periodUnit": "h"
}
},
"doseAndRate": [
{
"doseQuantity": {
"value": 3,
"unit": "mg/kg",
"system": "http://unitsofmeasure.org",
"code": "mg/kg"
}
}
],
"maxDosePerPeriod": [
{
"numerator": {
"value": 12,
"unit": "mg/kg",
"system": "http://unitsofmeasure.org",
"code": "mg/kg"
},
"denominator": {
"value": 72,
"unit": "hours",
"system": "http://unitsofmeasure.org",
"code": "h"
}
}
]
}
]
}
],
"patientCharacteristic": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code": "age",
"display": "Age"
}
]
},
"valueRange": {
"low": {
"value": 0,
"unit": "days",
"system": "http://unitsofmeasure.org",
"code": "d"
},
"high": {
"value": 14,
"unit": "days",
"system": "http://unitsofmeasure.org",
"code": "d"
}
}
}
]
}
]
},
{
"indication": [
{
"reference": {
"reference": "ClinicalUseDefinition/cud-diflucan-invasive"
}
}
],
"dosingGuideline": [
{
"dosage": [
{
"type": {
"text": "Loading dose (Day 1)"
},
"dosage": [
{
"sequence": 1,
"text": "800 mg on Day 1",
"doseAndRate": [
{
"doseQuantity": {
"value": 800,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
}
}
]
}
]
},
{
"type": {
"text": "Maintenance"
},
"dosage": [
{
"sequence": 2,
"text": "400 mg once daily",
"timing": {
"repeat": {
"frequency": 1,
"period": 1,
"periodUnit": "d"
}
},
"doseAndRate": [
{
"doseQuantity": {
"value": 400,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
}
}
]
}
]
}
]
}
]
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-mucosal",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "cud-diflucan-mucosal",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-mucosal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-mucosal</b></p><a name=\"cud-diflucan-mucosal\"> </a><a name=\"hccud-diflucan-mucosal\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html\">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-mucosal</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}\">Indication</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 79740000}\">Candidiasis of mouth</span></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "cud-diflucan-mucosal"
}
],
"type": "indication",
"category": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code": "indication",
"display": "Indication"
}
]
}
],
"subject": [
{
"reference": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status": {
"coding": [
{
"system": "http://hl7.org/fhir/publication-status",
"code": "active",
"display": "Active"
}
]
},
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "79740000",
"display": "Candidiasis of mouth"
}
]
}
}
}
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-invasive",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "cud-diflucan-invasive",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-invasive\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-invasive</b></p><a name=\"cud-diflucan-invasive\"> </a><a name=\"hccud-diflucan-invasive\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html\">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-invasive</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}\">Indication</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 70572005}\">Invasive candidiasis</span></td></tr></table></blockquote><p><b>population</b>: <a href=\"Group-group-diflucan-adult.html\">Adults</a></p></div>"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "cud-diflucan-invasive"
}
],
"type": "indication",
"category": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code": "indication",
"display": "Indication"
}
]
}
],
"subject": [
{
"reference": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status": {
"coding": [
{
"system": "http://hl7.org/fhir/publication-status",
"code": "active",
"display": "Active"
}
]
},
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "70572005",
"display": "Invasive candidiasis"
}
]
}
}
},
"population": [
{
"reference": "Group/group-diflucan-adult",
"display": "Adults"
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-renal",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "cud-diflucan-renal",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-warning-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-renal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-renal</b></p><a name=\"cud-diflucan-renal\"> </a><a name=\"hccud-diflucan-renal\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-warning-uv-epi.html\">ClinicalUseDefinition Warning (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-renal</p><p><b>type</b>: Warning</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig warning}\">Warning</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>population</b>: <a href=\"Group-group-diflucan-renal.html\">Renal impairment (CrCl ≤ 50 mL/min)</a></p><h3>Warnings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 723188008}\">For multiple-dose therapy, after a normal loading dose, give 50% of the recommended daily dose when CrCl ≤ 50 mL/min (no haemodialysis); give 100% of the recommended dose after each haemodialysis session. Single-dose therapy needs no adjustment. This rule applies to every multiple-dose indication.</span></td></tr></table></div>"
},
"identifier": [
{
"system": "http://example.org/identifier",
"value": "cud-diflucan-renal"
}
],
"type": "warning",
"category": [
{
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code": "warning",
"display": "Warning"
}
]
}
],
"subject": [
{
"reference": "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status": {
"coding": [
{
"system": "http://hl7.org/fhir/publication-status",
"code": "active",
"display": "Active"
}
]
},
"population": [
{
"reference": "Group/group-diflucan-renal",
"display": "Renal impairment (CrCl ≤ 50 mL/min)"
}
],
"warning": {
"code": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "723188008",
"display": "Renal insufficiency"
}
],
"text": "For multiple-dose therapy, after a normal loading dose, give 50% of the recommended daily dose when CrCl ≤ 50 mL/min (no haemodialysis); give 100% of the recommended dose after each haemodialysis session. Single-dose therapy needs no adjustment. This rule applies to every multiple-dose indication."
}
}
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-adult",
"resource": {
"resourceType": "Group",
"id": "group-diflucan-adult",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Group_group-diflucan-adult\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Group group-diflucan-adult</b></p><a name=\"group-diflucan-adult\"> </a><a name=\"hcgroup-diflucan-adult\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Group-uv-epi.html\">Group (ePI)</a></p></div><p><b>type</b>: Person</p><p><b>membership</b>: Definitional</p><p><b>name</b>: Adults</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>18-? years</td><td>false</td></tr></table></div>"
},
"type": "person",
"membership": "definitional",
"name": "Adults",
"characteristic": [
{
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code": "age",
"display": "Age"
}
]
},
"valueRange": {
"low": {
"value": 18,
"unit": "years",
"system": "http://unitsofmeasure.org",
"code": "a"
}
},
"exclude": false
}
]
}
},
{
"fullUrl": "http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-renal",
"resource": {
"resourceType": "Group",
"id": "group-diflucan-renal",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Group_group-diflucan-renal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Group group-diflucan-renal</b></p><a name=\"group-diflucan-renal\"> </a><a name=\"hcgroup-diflucan-renal\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Group-uv-epi.html\">Group (ePI)</a></p></div><p><b>type</b>: Person</p><p><b>membership</b>: Definitional</p><p><b>name</b>: Renal impairment (CrCl ≤ 50 mL/min)</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type renal-function}\">Renal function</span></td><td>?-50</td><td>false</td></tr></table></div>"
},
"type": "person",
"membership": "definitional",
"name": "Renal impairment (CrCl ≤ 50 mL/min)",
"characteristic": [
{
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code": "renal-function",
"display": "Renal function"
}
]
},
"valueRange": {
"high": {
"value": 50,
"unit": "mL/min",
"system": "http://unitsofmeasure.org",
"code": "mL/min"
}
},
"exclude": false
}
]
}
}
]
}