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      v: Package leaflet: Information for the user Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) <img src="[binary]" annotationsrc="~/_entity/annotation/76a10366-26e0-ed11-a7c6-000d3aaa0403" />This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you receive this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Flucelvax Tetra is and what it is used for 2. What you need to know before you receive Flucelvax Tetra 3. How Flucelvax Tetra is given 4. Possible side effects 5. How to store Flucelvax Tetra 6. Contents of the pack and other information
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        v: 1. What asdad is and what it is used for
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        v: Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free. When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu. Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age. The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.
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        v: 2. What you need to know before you take asdad
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        v: If you are allergic to: · the active ingredients or any of the other ingredients of this medicine (listed in section 6) · beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.
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        v: Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra. BEFORE receiving the vaccine · Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Flucelvax Tetra as with all vaccines that are injected. · You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone. · You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”). · You should tell your doctor if you have a bleeding problem or bruise easily. · Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection. As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
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        v: Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical trials and during general use: Very serious side effects Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation: • Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) Serious side effects Tell your doctor immediately if you experience any of the following side effects – you may need medical attention: • You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system. • Extensive swelling of injected limb Mild side effects Very common (may affect more than 1 in 10 people): • Injection site pain, bruising, reddening and hardening or swelling at the site of the injection • Headache • Muscle pain • Tiredness • Loss of appetite • Irritability (only reported in children from 2 to < 6 years) • Sleepiness (only reported in children 2 to < 6 years) Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly. Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, eldery and children 9 to < 18 years. Common (may affect up to 1 in 10 people): • Nausea, vomiting, diarrhoea • Joint pain • Shivering • Change in eating habits (only reported in children from 2 to < 6 years) • Fever (> 38°C) Vomiting was uncommon in the elderly. Fever was uncommon in adults and the elderly. Not known (frequency cannot be estimated from the available data): • Numbness and tingling sensation (pa…
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        v: Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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        v: Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe). Flucelvax Tetra is a clear to slightly opalescent suspension. A single syringe contains 0.5 ml of suspension for injection. Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles. Not all pack sizes may be marketed.

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      l: rmswi
    code:
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    display:
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ingredient-for-flucelvax-potassiumchloride
type: Ingredient
id:
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meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
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identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
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status:
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for:
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role:
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    system:
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      l: rmswi
    code:
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    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
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status:
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for:
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role:
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      l: rmswi
    code:
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    display:
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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:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
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status:
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for:
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role:
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      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:
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identifier:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
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status:
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for:
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role:
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    system:
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      l: rmswi
    code:
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    display:
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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:
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    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 059QF0KO0R
status:
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for:
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role:
  coding:
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      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:
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  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:
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    v: official
  system:
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    l: beta
  value:
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version:
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status:
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    code:
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http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole
type: SubstanceDefinition
meta:
  profile:
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    l: SubstanceDefinition-uv-epi
text:
  status:
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  div:
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identifier:
  use:
    v: official
  system:
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    l: beta
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status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
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http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole
type: SubstanceDefinition
meta:
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    l: SubstanceDefinition-uv-epi
text:
  status:
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  div:
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identifier:
  use:
    v: official
  system:
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    l: beta
  value:
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status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
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http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole
type: SubstanceDefinition
meta:
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    l: SubstanceDefinition-uv-epi
text:
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identifier:
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    v: official
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    v: B3EV5T8SUF
status:
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    system:
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      l: publication-status
    code:
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http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1
type: AdministrableProductDefinition
meta:
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    l: AdministrableProductDefinition-uv-epi
text:
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identifier:
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    l: pmswi
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status:
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form of:
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administrable dose form:
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      l: rmswi
    code:
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    display:
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unit of presentation:
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      l: rmswi
    code:
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route of administration:
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        l: rmswi
      code:
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      display:
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http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc10
type: RegulatedAuthorization
meta:
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    l: RegulatedAuthorization-uv-epi
text:
  status:
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  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:
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subject:
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type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
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    display:
      v: Marketing Authorisation
status:
  coding:
    system:
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      l: publication-status
    code:
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    display:
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status date:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e
type: Organization
meta:
  profile:
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    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:
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    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100013715
active:
  v: true
type:
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    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:
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    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:
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name:
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type:
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    system:
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      l: rmswi
    code:
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package for:
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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:
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    v: 15
  system:
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    l: unitsofmeasure.org
  code:
    v: ug
copackaged indicator:
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packaging:
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      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073498
      display:
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  quantity:
    v: 1
  material:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 200000003529
      display:
        v: Cardboard
  packaging:
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      system:
        v: https://spor.ema.europa.eu/pmswi
        l: pmswi
      value:
        v: xxxx
    quantity:
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mpb6ced64d25ea2c8da6c6099386f14db1
type: MedicinalProductDefinition
id:
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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 mpb6ced64d25ea2c8da6c6099386f14db1 Profile: MedicinalProductDefinition (ePI) 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 name productName: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) type: Full name part part: Flucelvax Tetra type: Invented name part part part: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) type: Scientific name part part part: 15 ug type: Strength part part part: Solution for injection type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Spain Spain English
identifier:
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    l: pmswi
  value:
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identifier:
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    l: phpid
  value:
    v: 0xF79CABF272B6A7EEF104DDDA44E82717
type:
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    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:
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    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: active
legal status of supply:
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      l: rmswi
    code:
      v: 100000000000
    display:
      v: Medicinal product subject to medical prescription
name:
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  type:
    coding:
      system:
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        l: https://spor.ema.europa.eu/lists/220000000000
      code:
        v: 220000000001
      display:
        v: Full name
  part:
    part:
      v: Flucelvax Tetra
  part:
    part:
      v: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
  part:
    part:
      v: 15 ug
  part:
    part:
      v: Solution for injection

http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1
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-04c9bd6fb89d38b2d83eced2460c4dc1 Profile: ManufacturedItemDefinition (ePI) 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
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/18/1326/001
status:
  v: active
manufactured 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

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

v: 100000155538

v: unavailable

v: 100000155538

v: unavailable

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 9V4SVN4JQV

v: INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

v: ACTIB

v: active ingredient - basis of strength

v: JS7E5ZZ3AC

v: INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

v: ACTIB

v: active ingredient - basis of strength

v: BFA4LSE5QQ

v: INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

v: ACTIB

v: active ingredient - basis of strength

v: B3EV5T8SUF

v: INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE

v: ACTIB

v: active ingredient - basis of strength

v: 451W47IQ8X

v: Sodium chloride

v: 660YQ98I10

v: Potassium chloride

v: 02F3473H9O

v: MAGNESIUM CHLORIDE

v: 94255I6E2T

v: SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

v: 4J9FJ0HL51

v: Potassium dihydrogen phosphate

v: 059QF0KO0R

v: Water for injections

v: 100000109093

v: Human

v: 100000073498

v: 100000073498

v: 200000003529

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: Spain

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

v: ES

v: Spain

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

v: en

v: English