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    v: Generated Narrative: Composition compositione722f6782d3f34f86982e14386c8811dhh Language: es Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//yy status: Final type: Package Leaflet date: 2022-04-29 13:28:17+0000 author: Organization European Medicines Agency title: TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película Attesters - Mode Time * Official 2022-04-29 13:28:17+0000
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        v: Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina 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 dárselo 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.
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        v: Contenido del prospecto Qué es Dovato y para qué se utiliza Qué necesita saber antes de empezar a tomar Dovato Cómo tomar Dovato Posibles efectos adversos Conservación de Dovato Contenido del envase e información adicional
  section:
    title:
      v: 1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for
    code:
      text:
        v: 1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for
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        v: 1. Qué es Dovato y para qué se utiliza Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).
  section:
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      v: 2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película
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        v: 2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película
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        v: 2. Qué necesita saber antes de empezar a tomar Dovato No tome Dovato si es alérgico (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6) si está tomando un medicamento llamado fampridina (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).
  section:
    title:
      v: 3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película
    code:
      text:
        v: 3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película
    text:
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        v: additional
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        v: 3. Cómo tomar Dovato Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico. La dosis recomendada de Dovato es un comprimido una vez al día. Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.
  section:
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      v: 4. Possible side effects
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        v: 4. Possible side effects
    text:
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        v: additional
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        v: 4. Posibles efectos adversos Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.
  section:
    title:
      v: 5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película
    code:
      text:
        v: 5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película
    text:
      status:
        v: additional
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        v: 5. Conservación de Dovato Mantener este medicamento fuera de la vista y del alcance de los niños No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica. Este medicamento no requiere ninguna condición especial de conservación. Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.
  section:
    title:
      v: 6. Contents of the pack and other information
    code:
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        v: 6. Contents of the pack and other information
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        v: additional
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        v: 6. Contenido del envase e información adicional Composición de Dovato Los principios activos son dolutegravir y lamivudina. Cada comprimido contiene dolutegravir sódico equivalente a 50 mg de dolutegravir y 300 mg de lamivudina. Los demás componentes son celulosa microcristalina, carboximetilalmidón sódico, estearato de magnesio, manitol (E421), povidona (K29/32), fumarato estearilo de sodio, hipromelosa (E464), macrogol, dióxido de titanio (E171). Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.

ingredient-for-dovato-dolutegravirsodium
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      code:
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ingredient-for-dovato-lamivudine
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        v: mg

ingredient-for-dovato-microcrystallinecellulose
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ingredient-for-dovato-sodiumstarchglycolate
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ingredient-for-dovato-mannitol
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substance-dolutegravirsodium
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    v: Generated Narrative: SubstanceDefinition substance-dolutegravirsodium Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//1Q1V9V5WYQ (use: official, ) version: 1 status: Active manufacturer: Organization GLAXO WELLCOME, S.A. MolecularWeights - Type Amount * exact 441.36 Structures - MolecularFormula * C20H18F2N305.Na Names - Name Type * (4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDE Chemical Name
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status:
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      l: publication-status
    code:
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molecular weight:
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structure:
  molecular formula:
    v: C20H18F2N305.Na
name:
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    v: (4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDE
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      code:
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      display:
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substance-lamivudine
type: SubstanceDefinition
id:
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text:
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identifier:
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version:
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status:
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    code:
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molecular weight:
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structure:
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name:
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http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f
type: AdministrableProductDefinition
meta:
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text:
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identifier:
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status:
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form of:
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    display:
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unit of presentation:
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    code:
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    display:
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route of administration:
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      code:
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      display:
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http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization49178f16170ee8a6bc2a4361c1748d5f0
type: RegulatedAuthorization
meta:
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text:
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identifier:
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subject:
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type:
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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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status date:
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type: Organization
meta:
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text:
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identifier:
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  system:
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    l: omswi
  value:
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active:
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type:
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      l: rmswi
    code:
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    display:
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name:
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contact:
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    type:
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    text:
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    line:
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    city:
      v: Aranda De Duero
    country:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-31ff1af739c7dcf77386a86f8dd83d29
type: Organization
meta:
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    l: Organization-uv-epi
text:
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identifier:
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active:
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type:
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      l: rmswi
    code:
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    display:
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name:
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contact:
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    use:
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    type:
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    text:
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    line:
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    city:
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    country:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1
type: Organization
meta:
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    l: Organization-uv-epi
text:
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identifier:
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  system:
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    l: omswi
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active:
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type:
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    system:
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    code:
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    display:
      v: Medicines Regulatory Authority
name:
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contact:
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    use:
      v: work
    type:
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    text:
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    line:
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    city:
      v: Amsterdam
    postal code:
      v: 1083 HS
    country:
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http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-2977a2afce16a0bd914b8d242dd126b5
type: PackagedProductDefinition
meta:
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    l: PackagedProductDefinition-uv-epi
text:
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identifier:
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  system:
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    l: pmswi
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name:
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type:
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    code:
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    display:
      v: Chemical Medicinal Product
package for:
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status:
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    code:
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    display:
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status date:
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packaging:
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      display:
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id:
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meta:
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text:
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identifier:
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    display:
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domain:
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    code:
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status:
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name:
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status:
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v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 1Q1V9V5WYQ

v: DOLUTEGRAVIR SODIUM

v: ACTIB

v: active ingredient - basis of strength

v: 2T8Q726O95

v: lamivudine

v: ACTIB

v: active ingredient - basis of strength

v: OP1R32D61U

v: microcrystalline cellulose

v: H8AV0SQX4D

v: sodium starch glycolate

v: 70097M6I30

v: magnesium stearate

v: 3OWL53L36A

v: mannitol

v: 100000109093

v: Human

v: 100000073504

v: Child-resistant closure

v: 200000003203

v: Glass

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: GBR

v: United Kingdom

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

v: GBR

v: United Kingdom

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

v: en

v: English