Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fluenz

Document Subject

Generated Narrative: MedicinalProductDefinition mp2a76f37ef539585b5462eb33582e394e

identifier: http://ema.europa.eu/identifier/EU/1/13/887/003 Top load carton assembly. 1 sprayer.

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fluenz Tetra nasal spray suspension

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2a76f37ef539585b5462eb33582e394e

identifier: http://ema.europa.eu/identifier/EU/1/13/887/003 Top load carton assembly. 1 sprayer.

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fluenz

Attesters

What is in this leaflet:

1. What Fluenz Tetra is and what it is used for
2. What you need to know before you are given Fluenz Tetra
3. How Fluenz Tetra is given
4. Possible side effects
5. How to store Fluenz Tetra
6. Contents of the pack and other information

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.

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 Fluenz Tetra is not given at the same time as influenza-specific antiviral medicines, such as oseltamivir and zanamivir. This is because the vaccine may work less effectively. Your doctor, nurse or pharmacist will decide if Fluenz Tetra can be given at the same time as other vaccines. Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast-feeding, tell your doctor, nurse or pharmacist before receiving this vaccine. Fluenz Tetra is not recommended for women who are pregnant or are breast-feeding. Driving and using machines

Fluenz Tetra has no or negligible influence on the ability to drive and use machines.

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.

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 Tetra Very 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.

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.

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 (A/Norway/31694/2022, MEDI 369815) 107.0 0.5 FFU*** A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293)

107.0 0.5 FFU*** B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) 107.0 0.5 FFU*** B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444) 107.0 0.5 FFU*** ..................................................................................................................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. Marketing Authorisation Holder AstraZeneca AB SE-151 S dert lje Sweden Manufacturer AstraZeneca Nijmegen B.V., Lagelandseweg Nijmegen, 6545CG Netherlands MedImmune, UK Limited Plot 6, Renaissance Way Boulevard Industry Park Speke Liverpool L24 9JW United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: