enhanced-bundlekarveacalcium-pedro
type: Bundle
node role: treeRoot
id:
  v: enhanced-bundlekarveacalcium-pedro
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi
    l: Bundle-uv-epi
language:
  v: en
identifier:
  system:
    v: https://www.gravitatehealth.eu/sid/doc
    l: doc
  value:
    v: EU/1/97/049/001
type:
  v: document
timestamp:
  v: 2023-04-25T11:55:27Z
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Composition/enhanced-composition02e928f15b7b861b4b44915d9f1330ecg
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-calciumcarbonate
    l: ingredient-for-calciovitaminad-calciumcarbonate
  resource: ingredient-for-calciovitaminad-calciumcarbonate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-cholecalciferol
    l: ingredient-for-calciovitaminad-cholecalciferol
  resource: ingredient-for-calciovitaminad-cholecalciferol
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-sodium
    l: ingredient-for-calciovitaminad-sodium
  resource: ingredient-for-calciovitaminad-sodium
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-lactosemonohydrate
    l: ingredient-for-calciovitaminad-lactosemonohydrate
  resource: ingredient-for-calciovitaminad-lactosemonohydrate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-sucrose
    l: ingredient-for-calciovitaminad-sucrose
  resource: ingredient-for-calciovitaminad-sucrose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-hydrogenatedsoybeanoil
    l: ingredient-for-calciovitaminad-hydrogenatedsoybeanoil
  resource: ingredient-for-calciovitaminad-hydrogenatedsoybeanoil
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-anhydrouscitricacid
    l: ingredient-for-calciovitaminad-anhydrouscitricacid
  resource: ingredient-for-calciovitaminad-anhydrouscitricacid
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-sodiumbicarbonate
    l: ingredient-for-calciovitaminad-sodiumbicarbonate
  resource: ingredient-for-calciovitaminad-sodiumbicarbonate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-povidone
    l: ingredient-for-calciovitaminad-povidone
  resource: ingredient-for-calciovitaminad-povidone
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-saccharinsodium
    l: ingredient-for-calciovitaminad-saccharinsodium
  resource: ingredient-for-calciovitaminad-saccharinsodium
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-sodiumcyclamate
    l: ingredient-for-calciovitaminad-sodiumcyclamate
  resource: ingredient-for-calciovitaminad-sodiumcyclamate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calciovitaminad-macrogol6000
    l: ingredient-for-calciovitaminad-macrogol6000
  resource: ingredient-for-calciovitaminad-macrogol6000
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-calciumcarbonate
    l: substance-calciumcarbonate
  resource: substance-calciumcarbonate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-925dad38f0afbba36223a82b3a766438
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization925dad38f0afbba36223a82b3a7664380
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-b7afabe350ac415f70e662ba6c703030
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-740c0d6d7605c10cb166cd0ee16908f9
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpd4bcbbaec04bf6aceb2f71162205967e
    l: mpd4bcbbaec04bf6aceb2f71162205967e
  resource: mpd4bcbbaec04bf6aceb2f71162205967e
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-925dad38f0afbba36223a82b3a766438

http://hl7.eu/fhir/ig/gravitate-health/Composition/enhanced-composition02e928f15b7b861b4b44915d9f1330ecg
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi
    l: Composition-uv-epi
language:
  v: es
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition enhanced-composition02e928f15b7b861b4b44915d9f1330ecg Language: es Profile: Composition (ePI) eu/fhir/ig/gravitate-health/StructureDefinition/Lenses: mock-lib HtmlElementLink elementClass: pregnancyCategory concept: Pregnancy HtmlElementLink elementClass: pregnancyCategory concept: Pregnancy HtmlElementLink elementClass: breastfeedingCategory concept: Normal breast feeding (finding) HtmlElementLink elementClass: liver concept: Liver disease, other identifier: https://spor.ema.europa.eu/rmswi//cc status: Final type: Package Leaflet category: Focused date: 2022-02-16 13:28:17+0000 author: Organization Laboratorios Farmacéuticos ROVI, S.A. title: TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Attesters - Mode Time * Official 2022-02-16 13:28:17+0000
extension:
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/Lenses
    l: Lenses
  value: Reference
    l: mock-lib
    reference:
      v: mock-lib
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: pregnancyCategory
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/77386006
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: pregnancyCategory
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: breastfeedingCategory
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/69840006
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: liver
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
identifier:
  system:
    v: https://spor.ema.europa.eu/rmswi/
    l: rmswi
  value:
    v: cc
status:
  v: final
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: Package Leaflet
category:
  coding:
    system:
      v: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs
      l: epicategory-cs
    code:
      v: F
    display:
      v: Focused
subject:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
date:
  v: 2022-02-16T13:28:17Z
title:
  v: TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
attester:
  mode:
    coding:
      system:
        v: http://hl7.org/fhir/composition-attestation-mode
        l: composition-attestation-mode
      code:
        v: official
  time:
    v: 2022-02-16T13:28:17Z
section:
  title:
    v: B. Package Leaflet
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi/
        l: rmswi
      code:
        v: 100000155538
    text:
      v: B. PACKAGE LEAFLET
  text:
    status:
      v: additional
    div:
      v: unavailable
  empty reason:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/list-empty-reason
        l: list-empty-reason
      code:
        v: unavailable
  section:
    title:
      v: Package leaflet: Information for the user
    code:
      text:
        v: Package leaflet: Information for the user
    text:
      status:
        v: additional
      div:
        v: Prospecto: información para el usuario Calcio/Vitamina D3 ROVI 1000 mg / 880 UI comprimidos efervescentes Carbonato c álcico/colecalciferol (Vitamina D3) Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted. -Conserve este prospecto, ya que puede tener que volver a leerlo. -Si tiene alguna duda, consulte a su médico o farmacéutico. -Este medicamento se le ha recetado solamente a usted, y no debe d árselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles. -Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
  section:
    title:
      v: What is in this leaflet
    code:
      text:
        v: What is in this leaflet
    text:
      status:
        v: additional
      div:
        v: Contenido del prospecto Qué es Calcio/Vitamina D3 ROVI y para qué se utiliza Qué necesita saber antes de empezar a tomar Calcio/Vitamina D3 ROVI Cómo tomar Calcio/Vitamina D3 ROVI Posibles efectos adversos Conservación de Calcio/Vitamina D3 ROVI Contenido del envase e información adicional
  section:
    title:
      v: 1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for
    code:
      text:
        v: 1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for
    text:
      status:
        v: additional
      div:
        v: Calcio/Vitamina D3 ROVI son comprimidos efervescentes. Se presentan en envases con 30 comprimidos. Este medicamento es una asociación de calcio y vitamina D que est á indicada para la corrección de la deficiencia combinada de vitamina D y calcio en pacientes de edad avanzada así como suplemento de vitamina D y calcio como coadyuvante a la terapia específica para el tratamiento de la osteoporosis en pacientes con deficiencia o con alto riesgo de deficiencia combinada de vitamina D y calcio.
  section:
    title:
      v: 2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    code:
      text:
        v: 2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    text:
      status:
        v: additional
      div:
        v: No tome Calcio/Vitamina D3 ROVI: si es alérgico a los principios activos o a alguno de los dem ás componentes de este medicamento (incluidos en la sección 6), si usted presenta hipercalcemia (nivel de calcio anormalmente elevado en sangre), si usted presenta hipercalciuria (eliminación exagerada de calcio en orina), si usted tiene litiasis c álcica (c álculos en riñones), calcificación tisular (depósito de sales de calcio en los tejidos), si usted padece una enfermedad crónica del riñón, si usted presenta inmovilización prolongada acompañada por hipercalciuria y/o hipercalcemia. Este medicamento contiene aceite de soja. No debe utilizarse en caso de alergia al cacahuete o a la soja. Advertencias y precauciones: Consulte a su médico o farmacéutico antes de empezar a tomar Calcio/Vitamina D3 ROVI: - si tiene insuficiencia renal (incapacidad del riñón para realizar correctamente su función), - si tiene c álculos en el riñón, - si padece una enfermedad del corazón, sarcoidosis (inflamación a nivel de los ganglios linf áticos, los pulmones, el hígado, los ojos, la piel y otros tejidos), o se encuentra en tratamiento con glucósidos cardíacos (medicamentos utilizados cuando existe una incapacidad del corazón para realizar correctamente su función), - si recibe un tratamiento conjunto con otros productos con vitamina D, o est á sometido a un tratamiento prolongado o con dosis elevadas de suplementos de calcio. En este caso es posible que su médico deba efectuar controles clínicos de forma regular. Su médico le indicar á la frecuencia de estos controles. Toma de Calcio/Vitamina D3 ROVI con otros medicamentos: Informe a su médico o farmacéutico si est á utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento. Ciertos medicamentos pueden interferir con Calcio/Vitamina D3 ROVI; en estos casos puede ser necesario cambiar la dosis, interrumpir el tratamiento con alguno de ellos o esperar al menos unas horas entre la administración de ambos. …
  section:
    title:
      v: 3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    code:
      text:
        v: 3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    text:
      status:
        v: additional

ingredient-for-calciovitaminad-calciumcarbonate
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-calciumcarbonate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-calciumcarbonate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/H0G9379FGK (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * Calcium Carbonate Strengths - Presentation[x] Basis * 2500 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: H0G9379FGK
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 2500
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-calciovitaminad-cholecalciferol
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-cholecalciferol
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-cholecalciferol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/1C6V77QF41 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * cholecalciferol Strengths - Presentation[x] Basis * 22 ug (Details: UCUM codeug = 'ug') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 1C6V77QF41
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 22
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: ug

ingredient-for-calciovitaminad-sodium
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-sodium
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-sodium Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/9NEZ333N27 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * Sodium Strengths - Presentation[x] Basis * 96 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 9NEZ333N27
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 96
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-calciovitaminad-lactosemonohydrate
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-lactosemonohydrate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-lactosemonohydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/EWQ57Q8I5X (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * lactose monohydrate Strengths - Presentation[x] Basis * 396 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: EWQ57Q8I5X
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 396
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-calciovitaminad-sucrose
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-sucrose
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-sucrose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/C151H8M554 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * sucrose Strengths - Presentation[x] Basis * 3 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: C151H8M554
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 3
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-calciovitaminad-hydrogenatedsoybeanoil
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-hydrogenatedsoybeanoil
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-hydrogenatedsoybeanoil Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/A2M91M918C (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: active substance Codes - Concept * hydrogenated soybean oil Strengths - Presentation[x] Basis * 0 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: A2M91M918C
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 72072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 0
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-calciovitaminad-anhydrouscitricacid
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-anhydrouscitricacid
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-anhydrouscitricacid Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/XF417D3PSL (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * Anhydrous citric acid
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: XF417D3PSL
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

ingredient-for-calciovitaminad-sodiumbicarbonate
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-sodiumbicarbonate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-sodiumbicarbonate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/8MDF5V39QO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * sodium bicarbonate
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 8MDF5V39QO
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

ingredient-for-calciovitaminad-povidone
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-povidone
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-povidone Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/FZ989GH94E (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * povidone
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: FZ989GH94E
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

ingredient-for-calciovitaminad-saccharinsodium
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-saccharinsodium
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-saccharinsodium Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/SB8ZUX40TY (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * saccharin sodium
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: SB8ZUX40TY
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

ingredient-for-calciovitaminad-sodiumcyclamate
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-sodiumcyclamate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-sodiumcyclamate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/1I6F42RME1 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * sodium cyclamate
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 1I6F42RME1
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

ingredient-for-calciovitaminad-macrogol6000
type: Ingredient
id:
  v: ingredient-for-calciovitaminad-macrogol6000
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-calciovitaminad-macrogol6000 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/30IQX730WE (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#xx; status = active; administrableDoseForm = Effervescent tablet; unitOfPresentation = tablet role: excipient substance Codes - Concept * macrogol 6000
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 30IQX730WE
status:
  v: active
for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: excipient

substance-calciumcarbonate
type: SubstanceDefinition
id:
  v: substance-calciumcarbonate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition substance-calciumcarbonate Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//H0G9379FGK (use: official, ) version: 1 status: Active manufacturer: Organization Laboratorios Farmacéuticos ROVI, S.A. MolecularWeights - Type Amount * exact 100.09 Structures - MolecularFormula * CO3.Ca Names - Name Type * CALCII CARBONAS [WHO-IP LATIN] Chemical Name
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: H0G9379FGK
version:
  v: 1
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
molecular weight:
  type:
    text:
      v: exact
  amount:
    value:
      v: 100.09
structure:
  molecular formula:
    v: CO3.Ca
name:
  name:
    v: CALCII CARBONAS [WHO-IP LATIN]
  type:
    coding:
      system:
        v: https://gsrs.ncats.nih.gov/ginas/app/beta/
        l: beta
      code:
        v: x
      display:
        v: Chemical Name

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-925dad38f0afbba36223a82b3a766438
type: AdministrableProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition ap-925dad38f0afbba36223a82b3a766438 Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/xx status: Active formOf: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Effervescent tablet unitOfPresentation: tablet producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet routeOfAdministration code: Oral use TargetSpecies - Code * Human
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: xx
status:
  v: active
form of:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073681
    display:
      v: Effervescent tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002152
    display:
      v: tablet
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073619
      display:
        v: Oral use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization925dad38f0afbba36223a82b3a7664380
type: RegulatedAuthorization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authorization925dad38f0afbba36223a82b3a7664380 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/68290 (use: official, ) subject: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation status: Active statusDate: 2012-01-01 holder: Organization Laboratorios Farmacéuticos ROVI, S.A.
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: 68290
subject:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072062
    display:
      v: Marketing Authorisation
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2012-01-01

http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-b7afabe350ac415f70e662ba6c703030
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization mah-b7afabe350ac415f70e662ba6c703030 Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/xx (use: official, ) active: true type: Marketing authorisation holder name: Laboratorios Farmacéuticos ROVI, S.A. Contacts - Address * C/ Julián Camarillo, 35 Madrid ES(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: xx
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
name:
  v: Laboratorios Farmacéuticos ROVI, S.A.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: C/ Julián Camarillo, 35 Madrid ES
    line:
      v: C/ Julián Camarillo, 35
    city:
      v: Madrid
    postal code:
      v: 28037
    country:
      v: ES

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-740c0d6d7605c10cb166cd0ee16908f9
type: PackagedProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
    l: PackagedProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition ppd-740c0d6d7605c10cb166cd0ee16908f9 Profile: PackagedProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/x (use: official, ) name: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30 type: Chemical Medicinal Prodcut packageFor: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82716; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2012-01-03 containedItemQuantity: 2500 mg (Details: UCUM codemg = 'mg') copackagedIndicator: false packaging type: Box quantity: 1 material: Cardboard packaging identifier: https://spor.ema.europa.eu/pmswi/123456 type: Blister quantity: 30 material: cardboard containedItem Items - Reference * ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#68290 (use: official, ); status = active; manufacturedDoseForm = Effervescent tablet; unitOfPresentation = tablet
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: x
name:
  v: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medicinal Prodcut
package for:
  l: mpd4bcbbaec04bf6aceb2f71162205967e
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2012-01-03
contained item quantity:
  value:
    v: 2500
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: mg
copackaged indicator:
  v: false
packaging:
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073498
      display:
        v: Box
  quantity:
    v: 1
  material:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 200000003529
      display:
        v: Cardboard
  packaging:
    identifier:
      system:
        v: https://spor.ema.europa.eu/pmswi
        l: pmswi
      value:
        v: 123456
    quantity:
      v: 30

mpd4bcbbaec04bf6aceb2f71162205967e
type: MedicinalProductDefinition
id:
  v: mpd4bcbbaec04bf6aceb2f71162205967e
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
    l: MedicinalProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition mpd4bcbbaec04bf6aceb2f71162205967e Profile: MedicinalProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/68290, https://www.who-umc.org/phpid/0xF79CABF272B6A7EEF104DDDA44E82716 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes type: Full name part part: Calcio/Vitamina type: Invented name part part part: Calcium carbonate/Vitamin D3 type: Scientific name part part part: 2500 mg type: Strength part part part: Effervescent tablet type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Spain Spain English
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: 68290
identifier:
  system:
    v: https://www.who-umc.org/phpid
    l: phpid
  value:
    v: 0xF79CABF272B6A7EEF104DDDA44E82716
type:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-type
      l: medicinal-product-type
    code:
      v: MedicinalProduct
    display:
      v: Medicinal Product
domain:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
      v: Human
    display:
      v: Human use
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: active
legal status of supply:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000000000
    display:
      v: Medicinal product subject to medical prescription
name:
  product name:
    v: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/lists/220000000000
        l: https://spor.ema.europa.eu/lists/220000000000
      code:
        v: 220000000001
      display:
        v: Full name
  part:
    part:
      v: Calcio/Vitamina
  part:
    part:
      v: Calcium carbonate/Vitamin D3
  part:
    part:
      v: 2500 mg
  part:
    part:
      v: Effervescent tablet

http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-925dad38f0afbba36223a82b3a766438
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi
    l: ManufacturedItemDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition mid-925dad38f0afbba36223a82b3a766438 Profile: ManufacturedItemDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/68290 (use: official, ) status: Active manufacturedDoseForm: Effervescent tablet unitOfPresentation: tablet
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: 68290
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000073681
    display:
      v: Effervescent tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002152
    display:
      v: tablet

http://snomed.info/id/77386006
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 77386006
display:
  v: Pregnancy

system:
  v: https://icpc2.icd.com/
  l: icpc2.icd.com
code:
  v: W78
display:
  v: Pregnancy

http://snomed.info/id/69840006
system:
  v: http://snomed.info/sct
  l: sct
code:
  v: 69840006
display:
  v: Normal breast feeding (finding)

system:
  v: https://icpc2.icd.com/
  l: icpc2.icd.com
code:
  v: D97
display:
  v: Liver disease, other

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico. En caso de duda, consulte de nuevo a su médico o farmacéutico. Dosis Adultos La dosis recomendada es de 1 comprimido efervescente (1000 mg de calcio y 880 UI de Vitamina D3) al día. Forma y vía de administración Este medicamento se administra por vía oral. Disolver el comprimido en un vaso de agua y beber inmediatamente. Duración del tratamiento Su médico le indicar á la duración de su tratamiento con Calcio / Vitamina D3 ROVI. No suspenda antes el tratamiento. Siga estas instrucciones a menos que su médico le haya dado otras indicaciones distintas. En estos casos es conveniente solicitar al médico las instrucciones por escrito y asegurarse de haberlas entendido bien. Si estima que la acción de Calcio/Vitamina D3 ROVI es demasiado fuerte o débil, comuníqueselo a su médico o farmacéutico. Recuerde tomar su medicamento. Si toma m ás Calcio/Vitamina D3 ROVI del que debe Si toma m ás Calcio/Vitamina D3 ROVI del que debe, o en caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono: 91.562.04.20, indicando el medicamento y la cantidad ingerida. La sobredosis puede provocar hipervitaminosis D (exceso de vitamina D) e hipercalcemia (nivel de calcio anormalmente elevado en sangre). Los síntomas en caso de sobredosis son: n áuseas, vómitos, anorexia (trastorno de la alimentación), dolor en el abdomen, sequedad de boca o poliuria (aumento del volumen de orina eliminado), o bien, irritabilidad, letargia (cansancio excesivo), estupor (disminución de la respuesta a los estímulos) y coma (pérdida de la conciencia) en casos severos. Si olvidó tomar Calcio/Vitamina D3 ROVI No tome una dosis doble para compensar las dosis olvidadas. Si interrumpe el tratamiento con Calcio/Vitamina D3 ROVI Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farm…

title:
  v: 4. Possible side effects
code:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: 4. Possible side effects
text:
  status:
    v: additional
  div:
    v: Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran. -Poco frecuentes (pueden afectar a entre 1 y 10 de cada 1.000 pacientes ): niveles altos de calcio en sangre hipercalcemia, niveles altos de calcio en orina hipercalciuria. -Raros (pueden afectar a entre 1 y 10 de cada 10.000 pacientes ): estreñimiento, flatulencia, n áuseas, dolor epig ástrico, diarrea. -Muy raros (pueden afectar a menos de 1 de cada 10.000 pacientes):): picor (prurito), erupción de la piel (exantema), ronchas (urticaria). Comunicación de efectos adversos Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar m ás información sobre la seguridad de este medicamento.

title:
  v: 5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
code:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: 5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
text:
  status:
    v: additional
  div:
    v: Mantener este medicamento fuera de la vista y del alcance de los niños. Conservar en el envase original para protegerlo de la humedad. No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD. La fecha de caducidad es el último día del mes que se indica. Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudar á a proteger el medio ambiente

title:
  v: 6. Contents of the pack and other information
code:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: 6. Contents of the pack and other information
text:
  status:
    v: additional
  div:
    v: Composición de Calcio/Vitamina D3 ROVI -Los principios activos son: carbonato de calcio y concentrado de colecalciferol (en forma de polvo). Cada comprimido contiene 2500 mg de carbonato de calcio (equivalente a 1.000 mg de calcio) y 22 microgramos de concentrado de colecalciferol en forma de polvo (equivalente a 880 UI de colecalciferol = vitamina D3). -Los dem ás componentes (excipientes) son: ácido cítrico anhidro, bicarbonato de sodio, lactosa monohidratada, povidona, sacarina sódica, ciclamato de sodio, macrogol 6000, aroma de naranja (contiene maltodextrina procedente de maíz), emulsión de simeticona, ?-tocoferol, aceite de soja hidrogenado, gelatina, sacarosa y almidón de maíz sin gluten. Aspecto del producto y contenido del envase Comprimidos efervescentes cilíndricos, de color blanco o blanquecino. Se presentan en tubos de polipropileno, que contienen 15 comprimidos efervescentes cada uno. Cada envase contiene dos tubos (30 comprimidos efervescentes). Titular de la autorización de comercialización Laboratorios Farmacéuticos ROVI, S.A. C/ Juli án Camarillo, 35 28037 - Madrid España Responsable de la fabricación: Laboratorios Losan Pharma GMBH Otto-Hahn-Strasse 13 79395 - Neuenburg Alemania Fecha de la última revisión de este prospecto: julio 2019 La información detallada de este medicamento est á disponible en la p ágina web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (https://www.aemps.gob.es/)

v: H0G9379FGK

v: Calcium Carbonate

v: ACTIB

v: active ingredient - basis of strength

v: 1C6V77QF41

v: cholecalciferol

v: ACTIB

v: active ingredient - basis of strength

v: 9NEZ333N27

v: Sodium

v: ACTIB

v: active ingredient - basis of strength

v: EWQ57Q8I5X

v: lactose monohydrate

v: ACTIB

v: active ingredient - basis of strength

v: C151H8M554

v: sucrose

v: ACTIB

v: active ingredient - basis of strength

v: A2M91M918C

v: hydrogenated soybean oil

v: ACTIB

v: active ingredient - basis of strength

v: XF417D3PSL

v: Anhydrous citric acid

v: 8MDF5V39QO

v: sodium bicarbonate

v: FZ989GH94E

v: povidone

v: SB8ZUX40TY

v: saccharin sodium

v: 1I6F42RME1

v: sodium cyclamate

v: 30IQX730WE

v: macrogol 6000

v: 100000109093

v: Human

v: 100000073496

v: Blister

v: xxx

v: cardboard

v: 220000000002

v: Invented name part

v: 220000000003

v: Scientific name part

v: 220000000004

v: Strength part

v: 220000000005

v: Pharmaceutical dose form part

v: urn:iso:std:iso:3166
l: 3166

v: ES

v: urn:iso:std:iso:3166
l: 3166

v: ES

v: urn:ietf:bcp:47
l: 47

v: en

v: English