bundle-epi-type3-example-wondermox
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node role: treeRoot
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language:
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type:
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timestamp:
  v: 2025-12-10T21:36:02.056920
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    date:
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    author:
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      reference:
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    title:
      v: Package Leaflet: Information for the user - WonderMox 500 mg/125 mg
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      entry:
        l: cud-indication-infection
      entry:
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      entry:
        l: cud-interact-methotrexate
      entry:
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      entry:
        l: cud-side-diarrhea
      entry:
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      title:
        v: 2. What you need to know before you take WonderMox
    section:
      title:
        v: 3. How to take WonderMox
    section:
      title:
        v: 4. Possible side effects
    section:
      title:
        v: 5. How to store WonderMox
    section:
      title:
        v: 6. Contents of the pack and other information
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      v: generated
    div:
      v: Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000092629 version: 1; Last updated: 2025-11-26 10:53:25+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * AMOXICILLIN TRIHYDRATE strength presentation: 573.892 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152') referenceStrength Substances - Concept * Amoxicillin strength: 500 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')
  status:
    v: active
  for:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  for:
    l: WonderMox-500mg-125mg-EE-MID
    reference:
      v: ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID
  for:
    l: WonderMox-500mg-125mg-EE-APD
    reference:
      v: AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD
  role:
    coding:
      system:
        v: https://spor.ema.europa.eu/v1/lists/100000072050
        l: https://spor.ema.europa.eu/v1/lists/100000072050
      code:
        v: 100000072072
      display:
        v: Active
  substance:
    strength:
      presentation: Ratio
      reference strength:
        strength: Ratio

system:
  v: https://spor.ema.europa.eu/v2/SubstanceDefinition
  l: SubstanceDefinition
code:
  v: 100000092629
display:
  v: AMOXICILLIN TRIHYDRATE

value:
  v: 573.892
unit:
  v: milligram(s)
system:
  v: https://spor.ema.europa.eu/v1/lists/100000110633
  l: https://spor.ema.europa.eu/v1/lists/100000110633
code:
  v: 100000110655

value:
  v: 1
unit:
  v: tablet
system:
  v: https://spor.ema.europa.eu/v1/lists/200000000014
  l: https://spor.ema.europa.eu/v1/lists/200000000014
code:
  v: 200000002152

concept:
  coding:
    system:
      v: https://spor.ema.europa.eu/v2/SubstanceDefinition
      l: SubstanceDefinition
    code:
      v: 100000091596
    display:
      v: Amoxicillin

Ratio
numerator:
  value:
    v: 500
  unit:
    v: milligram(s)
  system:
    v: https://spor.ema.europa.eu/v1/lists/100000110633
    l: https://spor.ema.europa.eu/v1/lists/100000110633
  code:
    v: 100000110655
denominator:
  value:
    v: 1
  unit:
    v: tablet
  system:
    v: https://spor.ema.europa.eu/v1/lists/200000000014
    l: https://spor.ema.europa.eu/v1/lists/200000000014
  code:
    v: 200000002152

resource: Ingredient
  id:
    v: WonderMox-500mg-125mg-EE-I-100000093061
  meta:
    version id:
      v: 1
    last updated:
      v: 2025-11-26T10:53:26.087+00:00
    profile:
      v: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient
      l: PPLIngredient
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000093061 version: 1; Last updated: 2025-11-26 10:53:26+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * POTASSIUM CLAVULANATE strength presentation: 151.915 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152') referenceStrength Substances - Concept * CLAVULANIC ACID strength: 125 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')
  status:
    v: active
  for:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  for:
    l: WonderMox-500mg-125mg-EE-MID
    reference:
      v: ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID
  for:
    l: WonderMox-500mg-125mg-EE-APD
    reference:
      v: AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD
  role:
    coding:
      system:
        v: https://spor.ema.europa.eu/v1/lists/100000072050
        l: https://spor.ema.europa.eu/v1/lists/100000072050
      code:
        v: 100000072072
      display:
        v: Active
  substance:
    strength:
      presentation: Ratio
      reference strength:
        strength: Ratio

system:
  v: https://spor.ema.europa.eu/v2/SubstanceDefinition
  l: SubstanceDefinition
code:
  v: 100000093061
display:
  v: POTASSIUM CLAVULANATE

value:
  v: 151.915
unit:
  v: milligram(s)
system:
  v: https://spor.ema.europa.eu/v1/lists/100000110633
  l: https://spor.ema.europa.eu/v1/lists/100000110633
code:
  v: 100000110655

value:
  v: 1
unit:
  v: tablet
system:
  v: https://spor.ema.europa.eu/v1/lists/200000000014
  l: https://spor.ema.europa.eu/v1/lists/200000000014
code:
  v: 200000002152

concept:
  coding:
    system:
      v: https://spor.ema.europa.eu/v2/SubstanceDefinition
      l: SubstanceDefinition
    code:
      v: 100000089842
    display:
      v: CLAVULANIC ACID

Ratio
numerator:
  value:
    v: 125
  unit:
    v: milligram(s)
  system:
    v: https://spor.ema.europa.eu/v1/lists/100000110633
    l: https://spor.ema.europa.eu/v1/lists/100000110633
  code:
    v: 100000110655
denominator:
  value:
    v: 1
  unit:
    v: tablet
  system:
    v: https://spor.ema.europa.eu/v1/lists/200000000014
    l: https://spor.ema.europa.eu/v1/lists/200000000014
  code:
    v: 200000002152

resource: ManufacturedItemDefinition
  id:
    v: WonderMox-500mg-125mg-EE-MID
  meta:
    version id:
      v: 1
    last updated:
      v: 2025-11-26T10:51:49.850+00:00
    profile:
      v: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition
      l: PPLManufacturedItemDefinition
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ManufacturedItemDefinition WonderMox-500mg-125mg-EE-MID version: 1; Last updated: 2025-11-26 10:51:49+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
  status:
    v: active
  manufactured dose form:
    coding:
      system:
        v: https://spor.ema.europa.eu/v1/lists/200000000004
        l: https://spor.ema.europa.eu/v1/lists/200000000004
      code:
        v: 100000073665
      display:
        v: Film-coated tablet
  unit of presentation:
    coding:
      system:
        v: https://spor.ema.europa.eu/v1/lists/200000000014
        l: https://spor.ema.europa.eu/v1/lists/200000000014
      code:
        v: 200000002152
      display:
        v: Tablet

resource: Organization
  id:
    v: LOC-100009540-KrkaNovoMesto
  meta:
    version id:
      v: 1
    last updated:
      v: 2025-11-26T10:50:40.787+00:00
    profile:
      v: http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization
      l: PPLOrganization
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: Organization LOC-100009540-KrkaNovoMesto version: 1; Last updated: 2025-11-26 10:50:40+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization identifier: https://spor.ema.europa.eu/v1/locations/LOC-100009540, https://spor.ema.europa.eu/v1/organisations/ORG-100000627 name: KRKA, d.d., Novo mesto
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: LOC-100009540
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/organisations
      l: organisations
    value:
      v: ORG-100000627
  name:
    v: KRKA, d.d., Novo mesto

resource: ClinicalUseDefinition
  id:
    v: cud-indication-infection
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ClinicalUseDefinition cud-indication-infection type: Indication subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor indication DiseaseSymptomProcedures - Concept * Bacterial infectious disease
  type:
    v: indication
  subject:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  indication:
    disease symptom procedure:
      concept:
        coding: http://snomed.info/id/40733004

http://snomed.info/id/40733004
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 40733004
display:
  v: Bacterial infectious disease

resource: ClinicalUseDefinition
  id:
    v: cud-contra-penicillin-allergy
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ClinicalUseDefinition cud-contra-penicillin-allergy type: Contraindication subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor contraindication DiseaseSymptomProcedures - Concept * Allergy to penicillin
  type:
    v: contraindication
  subject:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  contraindication:
    disease symptom procedure:
      concept:
        coding: http://snomed.info/id/91936005

http://snomed.info/id/91936005
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 91936005
display:
  v: Allergy to penicillin

resource: ClinicalUseDefinition
  id:
    v: cud-interact-methotrexate
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ClinicalUseDefinition cud-interact-methotrexate type: Interaction subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor interaction Interactants - Item[x] * Methotrexate
  type:
    v: interaction
  subject:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  interaction:
    interactant:
      item: CodeableConcept
        coding: http://snomed.info/id/372567009

http://snomed.info/id/372567009
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 372567009
display:
  v: Methotrexate

resource: ClinicalUseDefinition
  id:
    v: cud-warning-hepatic
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ClinicalUseDefinition cud-warning-hepatic type: Warning subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor Warnings - Description * Use with caution in patients with hepatic impairment.
  type:
    v: warning
  subject:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  warning:
    description:
      v: Use with caution in patients with hepatic impairment.

resource: ClinicalUseDefinition
  id:
    v: cud-side-diarrhea
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: ClinicalUseDefinition cud-side-diarrhea type: Undesirable Effect subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor undesirableEffect SymptomConditionEffects - Concept * Diarrhea
  type:
    v: undesirable-effect
  subject:
    l: WonderMox-500mg-125mg-EE-MPD
    reference:
      v: MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD
  undesirable effect:
    symptom condition effect:
      concept:
        coding: http://snomed.info/id/62315008

http://snomed.info/id/62315008
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 62315008
display:
  v: Diarrhea

resource: MedicationKnowledge
  id:
    v: mk-wondermox
  language:
    v: en
  text:
    status:
      v: generated
    div:
      v: Generated Narrative: MedicationKnowledge mk-wondermox code: Amoxicillin + Clavulanic Acid status: Active indicationGuideline dosingGuideline treatmentIntent: Anti-infective treatment dosage Dosages - Text * One 500 mg/125 mg tablet every 8 hours
  code:
    coding: http://snomed.info/id/777067007
      system:
        v: http://snomed.info/sct
        l: sct
      code:
        v: 777067007
      display:
        v: Amoxicillin + Clavulanic Acid
  status:
    v: active
  indication guideline:
    dosing guideline:
      treatment intent:
        coding: http://snomed.info/id/373808002

http://snomed.info/id/373808002
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 373808002
display:
  v: Anti-infective treatment

text:
  v: One 500 mg/125 mg tablet every 8 hours