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http://hl7.eu/fhir/ig/gravitate-health/Composition/processed-composition02e928f15b7b861b4b44915d9f1330ec
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    v: Generated Narrative: Composition processed-en-composition02e928f15b7b861b4b44915d9f1330ec Language: en Profile: Composition (ePI) 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//cvd3-en status: Final type: Package Leaflet category: Processed 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
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  v: TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
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        v: Leaflet: Information for the user Calcium/Vitamin D3 ROVI 1000 mg / 880 IU effervescent tablets Calcium carbonate/cholecalciferol (Vitamin D3) Read this leaflet carefully before you start taking this medicine, as it contains important information for you. -Keep this leaflet. You may need to read it again. -If you have any questions, ask your doctor or pharmacist. -This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them. -If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
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        v: What is in this leaflet
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        v: Contents of the leaflet What Calcium/Vitamin D3 ROVI is and what it is used for What you need to know before you start taking Calcium/Vitamin D3 ROVI How to take Calcium/Vitamin D3 ROVI Possible side effects Storage of Calcium/Vitamin D3 ROVI Package contents and additional information
  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
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        v: additional
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        v: Calcium/Vitamin D3 ROVI are effervescent tablets. They are available in packages containing 30 tablets. This medicine is a combination of calcium and vitamin D, indicated for the correction of combined vitamin D and calcium deficiency in elderly patients, as well as a supplement of vitamin D and calcium as an adjunct to specific therapy for the treatment of osteoporosis in patients with deficiency or at high risk of combined vitamin D and calcium deficiency.
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      v: 2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    code:
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        v: 2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    text:
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        v: additional
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        v: Do not take Calcium/Vitamin D3 ROVI: if you are allergic to the active ingredients or any of the other components of this medicine (listed in section 6), if you have hypercalcemia (abnormally high levels of calcium in the blood), if you have hypercalciuria (excessive calcium in the urine), if you have kidney stones, tissue calcification (deposition of calcium salts in tissues), if you suffer from chronic kidney disease, if you have prolonged immobilization accompanied by hypercalciuria and/or hypercalcemia. This medicine contains soybean oil. Do not use it if you are allergic to peanuts or soy. Warnings and precautions: Consult your doctor or pharmacist before starting Calcium/Vitamin D3 ROVI: - if you have renal insufficiency (kidney impairment), - if you have kidney stones, - if you suffer from heart disease, sarcoidosis (inflammation affecting lymph nodes, lungs, liver, eyes, skin, and other tissues), or are undergoing treatment with cardiac glycosides (used for heart failure), - if you are taking other vitamin D products, or are undergoing prolonged or high-dose calcium supplementation. In this case, your doctor may need to conduct regular clinical monitoring. Your doctor will advise on the frequency of these checks. Taking Calcium/Vitamin D3 ROVI with other medicines: Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Certain medicines can interact with Calcium/Vitamin D3 ROVI, requiring dose adjustments, interruption, or at least a few hours between administrations. It is important to inform your doctor if you are taking or have recently taken any of the following medications: Cardiac glycosides (for heart conditions). Tetracyclines (certain antibiotics); wait at least 3 hours between doses. Thiazide diuretics (medications that increase urine output). Anticonvulsants. Systemic corticosteroids. Bisphosphonates and sodium fluoride; wait at least 3 hours between doses. Barbiturates or phenytoin. Taking Calcium…
  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
      div:
        v: Follow the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Dosage Adults The recommended dose is 1 effervescent tablet (1000 mg of calcium and 880 IU of Vitamin D3) per day. Method and route of administration This medicine is administered orally. Dissolve the tablet in a glass of water and drink immediately. Duration of treatment Your doctor will indicate the duration of your treatment with Calcium/Vitamin D3 ROVI. Do not stop treatment earlier. Follow these instructions unless your doctor gives you different directions. In such cases, it is advisable to request written instructions from the doctor and ensure you fully understand them. If you think the effect of Calcium/Vitamin D3 ROVI is too strong or too weak, inform your doctor or pharmacist. Remember to take your medicine. If you take more Calcium/Vitamin D3 ROVI than you should If you take more Calcium/Vitamin D3 ROVI than you should, or in case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested. Overdose can cause hypervitaminosis D (excess vitamin D) and hypercalcemia (abnormally high levels of calcium in the blood). Symptoms of overdose include nausea, vomiting, anorexia (eating disorder), abdominal pain, dry mouth, or polyuria (increased urine output), or irritability, lethargy (excessive fatigue), stupor (decreased response to stimuli), and coma (loss of consciousness) in severe cases. If you forgot to take Calcium/Vitamin D3 ROVI Do not take a double dose to make up for missed doses. If you stop taking Calcium/Vitamin D3 ROVI If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
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        v: 4. Possible side effects
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        v: Like all medicines, this medicine can cause side effects, although not everyone will experience them. -Uncommon (may affect between 1 and 10 in 1,000 patients): high calcium levels in the blood (hypercalcemia), high calcium levels in the urine (hypercalciuria). -Rare (may affect between 1 and 10 in 10,000 patients): constipation, flatulence, nausea, epigastric pain, diarrhea. -Very rare (may affect fewer than 1 in 10,000 patients): itching (pruritus), skin rash (exanthema), hives (urticaria). Reporting of side effects If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
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    title:
      v: 5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    code:
      text:
        v: 5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES
    text:
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        v: Keep this medicine out of the sight and reach of children. Store in the original package to protect it from moisture. Do not use this medicine after the expiry date stated on the package after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Take unused packaging and medicines to the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

ingredient-for-calciovitaminad-calciumcarbonate
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    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
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    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
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    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:
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identifier:
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  value:
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identifier:
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  value:
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type:
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    code:
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    display:
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domain:
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    code:
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    display:
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status:
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    code:
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    display:
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legal status of supply:
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name:
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      code:
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      display:
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  part:
    part:
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  part:
    part:
      v: 2500 mg
  part:
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http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-925dad38f0afbba36223a82b3a766438
type: ManufacturedItemDefinition
meta:
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identifier:
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status:
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http://snomed.info/id/77386006
system:
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code:
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display:
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system:
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code:
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display:
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http://snomed.info/id/69840006
system:
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code:
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display:
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system:
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code:
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display:
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v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

title:
  v: 6. Contents of the pack and other information
code:
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  text:
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text:
  status:
    v: additional
  div:
    v: Composition of Calcium/Vitamin D3 ROVI -The active ingredients are: calcium carbonate and concentrated cholecalciferol (in powder form). Each tablet contains 2500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 22 micrograms of concentrated cholecalciferol in powder form (equivalent to 880 IU of cholecalciferol = vitamin D3). -The other components (excipients) are: anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone, sodium saccharin, sodium cyclamate, macrogol 6000, orange flavor (contains maltodextrin derived from corn), simethicone emulsion, ?-tocopherol, hydrogenated soybean oil, gelatin, sucrose, and gluten-free corn starch. Product appearance and package contents Cylindrical effervescent tablets, white or whitish in color. They are presented in polypropylene tubes, each containing 15 effervescent tablets. Each package contains two tubes (30 effervescent tablets). Marketing authorization holder Laboratorios Farmacéuticos ROVI, S.A. C/ Julián Camarillo, 35 28037 - Madrid Spain Manufacturer: Laboratorios Losan Pharma GMBH Otto-Hahn-Strasse 13 79395 - Neuenburg Germany Date of the last revision of this leaflet: July 2019 Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)

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v: Calcium Carbonate

v: ACTIB

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v: cholecalciferol

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v: active ingredient - basis of strength

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v: Sodium

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v: active ingredient - basis of strength

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v: lactose monohydrate

v: ACTIB

v: active ingredient - basis of strength

v: C151H8M554

v: sucrose

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v: active ingredient - basis of strength

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v: hydrogenated soybean oil

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v: active ingredient - basis of strength

v: XF417D3PSL

v: Anhydrous citric acid

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v: sodium bicarbonate

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v: povidone

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v: saccharin sodium

v: 1I6F42RME1

v: sodium cyclamate

v: 30IQX730WE

v: macrogol 6000

v: 100000109093

v: Human

v: 100000073496

v: Blister

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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