{ "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"] }, "language" : "en", "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" : "

Diflucan Summary of Product Characteristics

" }, "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" : "
Summary of Product Characteristics for Diflucan
" }, "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" : "

Treatment of mucosal and invasive candidiasis.

" }, "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" : "

Dose depends on the indication and the patient population (see structured dosing). Renal impairment requires dose adjustment for multiple-dose therapy.

" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: Organization org-diflucan

Profile: Organization (ePI)

identifier: https://spor.ema.europa.eu/omswi/LOC-100000999

active: true

name: Example Pharma Ltd.

" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition mpd-diflucan

Profile: MedicinalProductDefinition (ePI)

identifier: http://ema.europa.eu/identifier/DIFLUCAN-150MG

status: Active

Names

-ProductName
*Diflucan 150 mg capsule
" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicationKnowledge mk-diflucan

Profile: MedicationKnowledge (ePI)

identifier: http://example.org/identifier/mk-diflucan

status: Active

indicationGuideline

Indications

-Reference
*ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-mucosal; type = indication; category = Indication; status = Active

dosingGuideline

dosage

type: Loading dose (Day 1)

dosage

sequence: 1

text: 200 to 400 mg on Day 1

DoseAndRates

-Dose[x]
*200-400 mg

dosage

type: Maintenance

dosage

sequence: 2

text: 100 to 200 mg once daily for 7 to 21 days

timing: Once per 1 day

DoseAndRates

-Dose[x]
*100-200 mg

PatientCharacteristics

-TypeValue[x]
*Age18-? years

dosingGuideline

dosage

type: Initial dose

dosage

sequence: 1

text: 6 mg/kg on the first day

DoseAndRates

-Dose[x]
*6 mg/kg (Details: UCUM codemg/kg = 'mg/kg')

dosage

type: Subsequent dose

dosage

sequence: 2

text: 3 mg/kg once daily

timing: Once per 1 day

DoseAndRates

-Dose[x]
*3 mg/kg (Details: UCUM codemg/kg = 'mg/kg')

PatientCharacteristics

-TypeValue[x]
*Age28-11 days

dosingGuideline

dosage

type: Neonatal dose

dosage

sequence: 1

text: 3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)

timing: Once per 72 hours

DoseAndRates

-Dose[x]
*3 mg/kg (Details: UCUM codemg/kg = 'mg/kg')

maxDosePerPeriod: 12 mg/kg (Details: UCUM codemg/kg = 'mg/kg')/72 hours (Details: UCUM codeh = 'h')

PatientCharacteristics

-TypeValue[x]
*Age0-14 days

indicationGuideline

Indications

-Reference
*ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-invasive; type = indication; category = Indication; status = Active

dosingGuideline

dosage

type: Loading dose (Day 1)

dosage

sequence: 1

text: 800 mg on Day 1

DoseAndRates

-Dose[x]
*800 mg (Details: UCUM codemg = 'mg')

dosage

type: Maintenance

dosage

sequence: 2

text: 400 mg once daily

timing: Once per 1 day

DoseAndRates

-Dose[x]
*400 mg (Details: UCUM codemg = 'mg')
" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: ClinicalUseDefinition cud-diflucan-mucosal

Profile: ClinicalUseDefinition Indication (ePI)

identifier: http://example.org/identifier/cud-diflucan-mucosal

type: Indication

category: Indication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active

status: Active

indication

DiseaseSymptomProcedures

-Concept
*Candidiasis of mouth
" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: ClinicalUseDefinition cud-diflucan-invasive

Profile: ClinicalUseDefinition Indication (ePI)

identifier: http://example.org/identifier/cud-diflucan-invasive

type: Indication

category: Indication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active

status: Active

indication

DiseaseSymptomProcedures

-Concept
*Invasive candidiasis

population: Adults

" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: ClinicalUseDefinition cud-diflucan-renal

Profile: ClinicalUseDefinition Warning (ePI)

identifier: http://example.org/identifier/cud-diflucan-renal

type: Warning

category: Warning

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active

status: Active

population: Renal impairment (CrCl ≤ 50 mL/min)

Warnings

-Code
*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.
" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: Group group-diflucan-adult

Profile: Group (ePI)

type: Person

membership: Definitional

name: Adults

Characteristics

-CodeValue[x]Exclude
*Age18-? yearsfalse
" }, "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"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: Group group-diflucan-renal

Profile: Group (ePI)

type: Person

membership: Definitional

name: Renal impairment (CrCl ≤ 50 mL/min)

Characteristics

-CodeValue[x]Exclude
*Renal function?-50false
" }, "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 }] } }] }