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        v: Prospecto: información para el usuario Flucelvax Tetra - suspensión inyectable en jeringa precargada Vacuna contra la gripe (antígeno de superficie, inactivado, preparada en cultivos celulares) Lea todo el prospecto detenidamente antes de empezar a recibir 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, farmacéutico o enfermero. - Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
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        v: Contenido del prospecto 1. Qué es Flucelvax Tetra y para qué se utiliza 2. Qué necesita saber antes de empezar a recibir Flucelvax Tetra 3. Cómo se administra Flucelvax Tetra 4. Posibles efectos adversos 5. Conservación de Flucelvax Tetra 6. Contenido del envase e información adicional
  section:
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      v: 1. What Flucelvax is and what it is used for
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        v: 1. Qué es Flucelvax Tetra y para qué se utiliza
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        v: Flucelvax Tetra es una vacuna contra la gripe. Flucelvax Tetra se prepara en cultivos celulares y, por lo tanto, no contiene huevo. Cuando una persona recibe la vacuna, el sistema inmunitario (el sistema de defensa natural del organismo) producirá su propia protección frente al virus de la gripe. Ninguno de los componentes de la vacuna puede causar la gripe. Flucelvax Tetra se usa para prevenir la gripe en adultos y niños a partir de los 2 años de edad. La vacuna va dirigida a cuatro cepas del virus de la gripe siguiendo las recomendaciones de la Organización Mundial de la Salud para la campaña 2023/2024.
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      v: 2. What you need to know before you take Flucelvax
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        v: 2. Qué necesita saber antes de empezar a recibir Flucelvax Tetra
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        v: No debe recibir Flucelvax Tetra: Si es alérgico a: los principios activos o alguno de los demás componentes de esta vacuna (incluidos en la sección 6). la beta-propiolactona, al bromuro de cetiltrimetilamonio o al polisorbato 80, que son residuos del proceso de fabricación que pueden estar presentes en cantidades mínimas. Advertencias y precauciones Consulte a su médico, farmacéutico o enfermero antes de empezar a recibir Flucelvax Tetra. ANTES DE vacunarse su médico o enfermero comprobará la fácil disponibilidad de tratamiento médico y supervisión adecuados en el caso raro de que se produjera una reacción anafiláctica (una reacción alérgica muy grave con síntomas como dificultad para respirar, mareos, pulso débil y rápido y erupción cutánea) después de la administración. Esta reacción puede presentarse con Flucelvax Tetra, al igual que con todas las vacunas que se inyectan. debe informar a su médico si tiene una enfermedad aguda que cursa con fiebre. Su médico puede decidir retrasar su vacunación hasta que la fiebre haya desaparecido. debe informar a su médico si su sistema inmunitario está comprometido o si está recibiendo un tratamiento que afecte al mismo, por ejemplo, medicamento contra el cáncer (quimioterapia) o corticoides (ver sección “Otros medicamentos y Flucelvax Tetra”). debe informar a su médico si tiene un problema de sangrado o le salen moretones fácilmente. puede desmayarse después de la inyección con una aguja, o incluso antes, por lo tanto, informe a su médico o enfermero si se ha desmayado anteriormente con alguna inyección. Como ocurre con todas las vacunas, Flucelvax Tetra puede no proteger completamente a todas las personas que son vacunadas. Otros medicamentos y Flucelvax Tetra Informe a su médico o enfermero si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta, o si ha recibido recientemente alguna otra vacuna. Flucelvax Tetra se puede administrar al mismo t…
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        v: Su médico o enfermero le administrará Flucelvax Tetra en forma de inyección en el músculo de la parte superior del brazo (músculo deltoides). Adultos y niños a partir de 2 años de edad: Una dosis de 0,5 ml Si su hijo es menor de 9 años y nunca ha sido vacunado contra la gripe, se le debe administrar una segunda dosis después, de al menos, 4 semanas.
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        v: 4. Posibles efectos adversos
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        v: Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran. Los siguientes efectos adversos se han notificado durante los ensayos clínicos y durante el uso general: Efectos adversos muy graves Consulte inmediatamente con su médico o acuda al servicio de urgencias del hospital más cercano si presenta el siguiente efecto adverso – puede necesitar urgentemente atención médica u hospitalización: Dificultad para respirar, mareos, pulso débil y rápido junto con erupción cutánea, que son los síntomas de una reacción anafiláctica (una reacción alérgica muy grave) Efectos adversos graves Informe inmediatamente a su médico si presenta cualquiera de los efectos adversos siguientes – puede necesitar atención médica: Se siente débil, tiene dificultades para moverse o presenta entumecimiento u hormigueo en las extremidades. Estos pueden ser síntomas del síndrome de Guillain-Barré (SGB), una enfermedad autoinmune causada por el propio sistema inmunitario del organismo Hinchazón extensa del miembro en el que se ha inyectado Efectos adversos leves Muy frecuentes (pueden afectar a más de 1 de cada 10 personas): Dolor en la zona de inyección, cardenales, enrojecimiento y endurecimiento o hinchazón en la zona de inyección Dolor de cabeza Dolor muscular Cansancio Pérdida de apetito Irritabilidad (notificada solo en niños de 2 a < 6 años) Somnolencia (notificada solo en niños de 2 a < 6 años) En los pacientes de edad avanzada fueron frecuentes el endurecimiento o la hinchazón en el lugar de la inyección, el dolor de cabeza, el dolor muscular y la fatiga. Los cardenales en el lugar de la inyección fueron frecuentes en adultos, ancianos y niños de 9 a < 18 años. El dolor de cabeza fue frecuente en ancianos. La pérdida de apetito fue frecuente en adultos, ancianos y niños de 9 a < 18 años. Frecuentes (pueden afectar hasta 1 de cada 10 personas): Náuseas, vómitos, diarrea Dolor articular Tiritona Cambios en los hábitos alime…
  section:
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      v: 5. How to store Flucelvax
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        v: 5. Conservación de Flucelvax Tetra
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        v: Mantener este medicamento fuera de la vista y del alcance de los niños. Conservar en nevera (entre 2 °C y 8 °C). No congelar. Mantener la jeringa precargada en el embalaje exterior para protegerla de la luz. No utilice esta vacuna después de la fecha de caducidad que aparece en la etiqueta y en la caja después de EXP/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. 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.
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    v: Generated Narrative: Ingredient ingredient-for-2c0c197a41a706fb2549601e635da1f3 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/B3EV5T8SUF (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: active substance Codes - Concept * INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE Strengths - Presentation[x] Basis * 15 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: B3EV5T8SUF
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 15
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: ug

ingredient-for-flucelvax-sodiumchloride
type: Ingredient
id:
  v: ingredient-for-flucelvax-sodiumchloride
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-flucelvax-sodiumchloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/451W47IQ8X (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * Sodium chloride
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 451W47IQ8X
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-flucelvax-potassiumchloride
type: Ingredient
id:
  v: ingredient-for-flucelvax-potassiumchloride
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-flucelvax-potassiumchloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/660YQ98I10 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * Potassium chloride
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 660YQ98I10
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-flucelvax-magnesiumchloride
type: Ingredient
id:
  v: ingredient-for-flucelvax-magnesiumchloride
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-flucelvax-magnesiumchloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/02F3473H9O (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * MAGNESIUM CHLORIDE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 02F3473H9O
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate
type: Ingredient
id:
  v: ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate
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-flucelvax-sodiumphosphatedibasicdihydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/94255I6E2T (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 94255I6E2T
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-flucelvax-potassiumdihydrogenphosphate
type: Ingredient
id:
  v: ingredient-for-flucelvax-potassiumdihydrogenphosphate
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-flucelvax-potassiumdihydrogenphosphate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/4J9FJ0HL51 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * Potassium dihydrogen phosphate
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 4J9FJ0HL51
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-flucelvax-waterforinjections
type: Ingredient
id:
  v: ingredient-for-flucelvax-waterforinjections
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-flucelvax-waterforinjections Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/059QF0KO0R (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; 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 = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * Water for injections
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 059QF0KO0R
status:
  v: active
for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole
type: SubstanceDefinition
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-influenzaavirusadelaware552019cvr45h1n1whole Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//9V4SVN4JQV (use: official, ) version: 1.0 status: Active manufacturer: Organization Seqirus Netherlands B.V.
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 9V4SVN4JQV
version:
  v: 1.0
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole
type: SubstanceDefinition
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-influenzaavirusadarwin112021h3n2whole Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//JS7E5ZZ3AC (use: official, ) status: Active manufacturer: Organization Seqirus Netherlands B.V.
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: JS7E5ZZ3AC
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole
type: SubstanceDefinition
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-influenzabvirusbsingaporewuh46182021whole Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//BFA4LSE5QQ (use: official, ) status: Active manufacturer: Organization Seqirus Netherlands B.V.
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: BFA4LSE5QQ
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole
type: SubstanceDefinition
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-influenzabvirusbsingaporeinftt1606102016whole Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//B3EV5T8SUF (use: official, ) status: Active manufacturer: Organization Seqirus Netherlands B.V.
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: B3EV5T8SUF
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1
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-04c9bd6fb89d38b2d83eced2460c4dc1 Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/xx status: Active formOf: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: suspension for injection in pre-filled syringe unitOfPresentation: Syringe producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe routeOfAdministration code: Subcutaneous use TargetSpecies - Code * Human
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: xx
status:
  v: active
form of:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000074063
    display:
      v: suspension for injection in pre-filled syringe
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002150
    display:
      v: Syringe
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073633
      display:
        v: Subcutaneous use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc10
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 authorization04c9bd6fb89d38b2d83eced2460c4dc10 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/18/1326/001 (use: official, ) subject: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation status: Active statusDate: 2019-01-01 holder: Organization Seqirus Netherlands B.V.
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/18/1326/001
subject:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
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: 2019-01-01

http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e
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-45fe50eae508b5755dd140ab2093eb5e Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100013715 (use: official, ) active: true type: Marketing authorisation holder name: Seqirus Netherlands B.V. Contacts - Address * Paasheuvelweg 28 1105BJ Amsterdam Netherlands(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100013715
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: Seqirus Netherlands B.V.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Paasheuvelweg 28 1105BJ Amsterdam Netherlands
    line:
      v: Paasheuvelweg 28
    city:
      v: 1105BJ Amsterdam
    postal code:
      v: 367061
    country:
      v: Netherlands

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395
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-a854b6fee6a8536c78c604a4b9f6c395 Profile: PackagedProductDefinition (ePI) name: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1 type: 100000155527 packageFor: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82717; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2019-01-01 containedItemQuantity: 15 ug (Details: UCUM codeug = 'ug') copackagedIndicator: true packaging type: Box quantity: 1 material: Cardboard packaging identifier: https://spor.ema.europa.eu/pmswi/xxxx type: 100000073498 quantity: 1 material: Cardboard containedItem Items - Reference * ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/18/1326/001 (use: official, ); status = active; manufacturedDoseForm = suspension for injection in pre-filled syringe; unitOfPresentation = Syringe
name:
  v: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
package for:
  l: mpb6ced64d25ea2c8da6c6099386f14db1
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2019-01-01
contained item quantity:
  value:
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  v: Composición de Flucelvax Tetra Los principios activos son antígenos de superficie del virus de la gripe (hemaglutinina y neuraminidasa), inactivados, de las siguientes cepas*: Cepa similar a A/Wisconsin/67/2022 (H1N1)pdm09 (A/Georgia/12/2022 CVR-167) 15 microgramos HA** Cepa similar a A/Darwin/6/2021 (H3N2) (A/Darwin/11/2021, wild type) 15 microgramos HA** Cepa similar a B/Austria/1359417/2021 (Singapore/WUH4618/2021, wild type) 15 microgramos HA** Cepa similar a B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type) 15 microgramos HA** por dosis de 0,5 ml ………………………………………. * propagadas en células Madin Darby Canine Kidney (MDCK) (se trata de un cultivo celular especial en el que crece el virus de la gripe) ** hemaglutinina Esta vacuna cumple con la recomendación de la Organización Mundial de la Salud (OMS) (hemisferio norte) y con la recomendación de la UE para la CAMPAÑA 2023/2024. Los demás componentes son: cloruro de sodio, cloruro de potasio, cloruro de magnesio hexahidrato, fosfato disódico dihidrato, dihidrogenofosfato de potasio y agua para preparaciones inyectables. Aspecto del producto y contenido del envase Flucelvax Tetra es una suspensión inyectable en jeringa precargada (jeringa lista para usar). Flucelvax Tetra es una suspensión de transparente a ligeramente opalescente. Cada jeringa individual contiene 0,5 ml de suspensión inyectable. Flucelvax Tetra está disponible en envases de 1 jeringa precargada con o sin aguja o 10 jeringas precargadas con o sin agujas. Puede que solamente estén comercializados algunos tamaños de envases. Titular de la autorización de comercialización y responsable de la fabricación Seqirus Netherlands B.V. Paasheuvelweg 28 1105BJ Amsterdam Países Bajos Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización: Seqirus Spain, S.L., Barcelona Tel: 937 817 884 Fecha de la última revisión de este prospecto: 07/2023 Otras fuentes de inf…

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