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        v: Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. This vaccine has been prescribed for you or your child only. Do not pass it on to others. If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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        v: What is in this leaflet: What Fluenz Tetra is and what it is used for What you need to know before you are given Fluenz Tetra How Fluenz Tetra is given Possible side effects How to store Fluenz Tetra Contents of the pack and other information
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        v: Fluenz Tetra is a vaccine to prevent influenza (flu). It is used in children and adolescents 24 months to less than 18 years of age. Fluenz Tetra will help to protect against the four virus strains contained in the vaccine, and other strains closely related to them. How Fluenz Tetra works 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 the flu. Fluenz Tetra vaccine viruses are grown in chicken eggs. Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
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        v: You will not be given Fluenz Tetra: if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”). if you have ever had a severe allergic reaction to eggs or egg proteins. For signs of allergic reactions, see section 4 “Possible side effects”. if you have a blood disorder or a cancer that affects the immune system. if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine or other treatment. if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever). This is because of the risk of a very rare but serious disease (Reye’s syndrome). If any of these apply, tell your doctor, nurse or pharmacist. Warnings and precautions Talk to your doctor, nurse or pharmacist before vaccination: if the child is less than 24 months of age. Children less than 24 months of age should not receive this vaccine because of the risk of side effects. if you have severe asthma or are currently wheezing. if you are in close contact with someone with a severely weakened immune system (for example, a bone marrow transplant patient needing isolation). If any of these apply, tell your doctor, nurse or pharmacist before vaccination. He or she will decide if Fluenz Tetra is suitable for you. Other medicines, other vaccines and Fluenz Tetra Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines, including medicines that do not require a prescription. Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Fluenz Tetra unless your doctor, nurse or pharmacist tells you otherwise. This is because of the risk of Reye’s syndrome, a very rare but serious disease that can affect the brain and liver. It is recommended that Fl…
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        v: Fluenz Tetra will be administered under the supervision of a doctor, nurse or pharmacist. Fluenz Tetra must only be used as a nasal spray. Fluenz Tetra must not be injected. Fluenz Tetra will be given as a spray in each nostril. You can breathe normally while you are given Fluenz Tetra. You do not need to actively inhale or sniff. Dosage The recommended dose for children and adolescents is 0.2 ml Fluenz Tetra, administered as 0.1 ml in each nostril. Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks. Follow your doctor, nurse or pharmacist’s instructions about if and when your child should return for the second dose. If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
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        v: Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies with the vaccine, most side effects were mild in nature and short term. Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz Tetra. Some side effects may be serious Very rare(may affect up to 1 in 10,000 people): severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue. Tell your doctor straight away or seek urgent medical care if you experience any of the effects above. Other possible side effects of Fluenz TetraVery common(may affect more than 1 in 10 people): runny or stuffy nose reduced appetite weakness Common(may affect up to 1 in 10 people): fever muscle aches headache Uncommon(may affect up to 1 in 100 people): rash nose bleed allergic reactions Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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        v: Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP. Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the nasal applicator in the outer carton in order to protect from light. Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12 hour period, it should be discarded. 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: What Fluenz Tetra contains The active substances are: Reassortant influenza virus (live attenuated) of the following four strains*: A/Victoria/4897/2022 (H1N1)pdm09 - like strain E107.0±0.5 FFU* (A/Norway/31694/2022, MEDI 369815) A/Darwin/9/2021 (H3N2) - like strain E107.0±0.5 FFU* (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain E107.0±0.5 FFU* (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain E107.0±0.5 FFU* (B/Phuket/3073/2013, MEDI 306444) .................................................................................................................. per 0.2 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks. produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).* fluorescent focus units. This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2023/2024 season. The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections. What Fluenz Tetra looks like and contents of the pack This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10. Not all pack sizes may be available in your country. The suspension is colourless to pale yellow, clear to slightly cloudy. Small white particles may be present.

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identifier:
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    v: official
  system:
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    l: beta
  value:
    v: nan
status:
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for:
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role:
  coding:
    system:
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      l: rmswi
    code:
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    display:
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ingredient-for-vaxigriptetra-potassiumdihydrogenphosphate
type: Ingredient
id:
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meta:
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    l: Ingredient-uv-epi
text:
  status:
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identifier:
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    v: official
  system:
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    l: beta
  value:
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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-vaxigriptetra-gelatinporcinetypea
type: Ingredient
id:
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meta:
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    l: Ingredient-uv-epi
text:
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identifier:
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  system:
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    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-vaxigriptetra-argininehydrochloride
type: Ingredient
id:
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meta:
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    l: Ingredient-uv-epi
text:
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identifier:
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    l: beta
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status:
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for:
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role:
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    code:
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    display:
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ingredient-for-vaxigriptetra-monosodiumglutamatemonohydrate
type: Ingredient
id:
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meta:
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    l: Ingredient-uv-epi
text:
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identifier:
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  system:
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status:
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for:
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role:
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    code:
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    display:
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ingredient-for-vaxigriptetra-waterforinjections
type: Ingredient
id:
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meta:
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    l: Ingredient-uv-epi
text:
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identifier:
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  system:
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    l: beta
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status:
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for:
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role:
  coding:
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      l: rmswi
    code:
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    display:
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http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-635d47ee543a5a9e15fcd321ee5fe6bb
type: AdministrableProductDefinition
meta:
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    l: AdministrableProductDefinition-uv-epi
text:
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identifier:
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status:
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form of:
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administrable dose form:
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    code:
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unit of presentation:
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route of administration:
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http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization635d47ee543a5a9e15fcd321ee5fe6bb0
type: RegulatedAuthorization
meta:
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text:
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identifier:
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  system:
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    l: pmswi
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type:
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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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http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization635d47ee543a5a9e15fcd321ee5fe6bb1
type: RegulatedAuthorization
meta:
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    l: RegulatedAuthorization-uv-epi
text:
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identifier:
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  system:
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  value:
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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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http://hl7.eu/fhir/ig/gravitate-health/Organization/man-05de1a64764c002add42fbfd49b6a38d
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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      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:
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    postal code:
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    country:
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http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-46a3afc149c080384b82a9e476e79f76
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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    display:
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name:
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contact:
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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/PackagedProductDefinition/ppd-f22a97fafd26aa7001d9fe6a30afa7b2
type: PackagedProductDefinition
meta:
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text:
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identifier:
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name:
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type:
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    display:
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package for:
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status:
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status date:
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packaging:
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type: PackagedProductDefinition
meta:
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text:
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name:
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status date:
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packaging:
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mp822aeee7cf35efce0583ec39919328fb
type: MedicinalProductDefinition
id:
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meta:
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text:
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identifier:
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type:
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    display:
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domain:
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status:
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legal status of supply:
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name:
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        v: 220000000001
      display:
        v: Full name
  part:
    part:
      v: Fluenz Tetra
  part:
    part:
      v: Reassortant influenza virus* (live attenuated) of four strains
  part:
    part:
      v: Nasal Spray

http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-635d47ee543a5a9e15fcd321ee5fe6bb
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-635d47ee543a5a9e15fcd321ee5fe6bb Profile: ManufacturedItemDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/nan (use: official, ) status: Active manufacturedDoseForm: Nasal spray unitOfPresentation: Spray manufacturer: Organization MedImmune, UK Limited
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: nan
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 200000016474
    display:
      v: Nasal spray
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000016451
    display:
      v: Spray

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: nan

v: A/Victoria/4897/2022

v: ACTIB

v: active ingredient - basis of strength

v: nan

v: A/Darwin/9/2021 (H3N2)

v: ACTIB

v: active ingredient - basis of strength

v: nan

v: B/Austria/1359417/2021

v: ACTIB

v: active ingredient - basis of strength

v: nan

v: B/Phuket/3073/2013 -

v: ACTIB

v: active ingredient - basis of strength

v: nan

v: Sucrose

v: nan

v: Dipotassium phosphate

v: nan

v: Potassium dihydrogen phosphate

v: nan

v: Gelatin (porcine, Type A)

v: nan

v: Arginine hydrochloride

v: nan

v: Monosodium glutamate monohydrate

v: nan

v: Water for injections

v: 100000109093

v: Human

v: 100000073533

v: Nasal applicator

v: 100000073533

v: Nasal applicator

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: DK

v: Denmark

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

v: DK

v: Denmark

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

v: en

v: English