InfoCons Consumer Protection informs you – Fluenz – Package Leaflet

Before anything else

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 you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Fluenz is and what it is used for

Fluenz is a vaccine to prevent influenza (flu). It is used in children and adolescents 2 years to less than 18 years of age. Fluenz will help to protect against the virus strains contained in the vaccine, and other strains closely related to them.

How Fluenz 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 vaccine viruses are grown in chicken eggs. Each year the vaccine targets three strains of influenza, following the annual recommendations by the World Health Organisation.

⚠️ 2. What you need to know before you are given Fluenz

You will not be given Fluenz :

• if you are allergic to the active ingredients, gentamicin (trace residue from the manufacturing process ), or any of the other ingredients of this vaccine listed in section 6.
• if you have ever had a severe allergic reaction to eggs or egg proteins. For signs of allergic reactions, see section 4.
• 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 (such as acute and chronic leukaemias, lymphoma, symptomatic HIV infection, cellular immune deficiencies, and high -dose corticosteroids) .
• 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 .

22 Warnings and precautions 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.

Talk to your doctor, nurse or pharmacist before vaccination:

• if you have severe asthma or are currently wheezing.
• if you have a severe acute illness associated with fever or infection, or if you have nasal blockage. Your doctor may decide to delay your vaccination until your fever or nasal blockage is gone.
• if you have ever fainted after a previous vaccination. Fainting can occur after this vaccine is given as a nasal spray.
• if you are in close contact with someone with a severely weakened immune system (for example, a bone marrow transplant patient needing isolation).
• if you have any birth defects that affect the bones and tissues of the skull and face, which have not undergone surgical correction.

If any of these apply, tell your doctor, nurse or pharmacist before vaccination . He or she will decide if Fluenz is suitable for you.

Children less than 2 years of age Children less than 2 years of age should not receive this vaccine because of the risk of side effects.

Other medicines, other vaccines and Fluenz 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 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 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 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 is not recommended for women who are pregnant or are breast -feeding.

Driving and using machines

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

💊 3. How Fluenz is given

Fluenz must only be used as a nasal spray.

Fluenz must not be injected.

Fluenz will be given as a spray in each nostril. You can breathe normally while you are given Fluenz .

You do not need to actively inhale or sniff.

Dose The recommended dose for children and adolescents is 0.2 ml Fluenz , administered as 0.1 ml in each nostril. Children 2 to 8 years of age who have not previously had an influenza vaccine will receive 23 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.

❗ 4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz .

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

Very common (may affect more than 1 in 10 people)

• runny or stuffy nose
• reduced appetite
• feeling generally unwell

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

Not known (frequency cannot be estimated from the available data)

• fainting (syncope)

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.

🌡️ 5. How to store Fluenz

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 and the carton after the letters EXP.

Store in a refrigerator (2°C – 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.

📦 6. Contents of the pack and other information

What Fluenz contains

The active substances are:

Reassortant influenza virus* (live attenuated) of the following three strains**:

A/Missouri/11/2025 (H1N1) pdm09 -like strain (A/Switze rland/6849/2025 , MEDI 400592 ) 107.0±0.5 FFU*** A/Darwin/1454/2025 (H3N2) -like strain (A/Darwin/1369/2025 , MEDI 406666 ) 107.0±0.5 FFU*** B/Tokyo/EIS13 -175/2025 -like strain (B/Perth/115/2025 , MEDI 407730 ) 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 2026/2027 season.

The vaccine may contain traces of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The other ingredients are sucrose, dipotassium phosphate , potassium dihydrogen phosphate , gelatin, arginine hydrochloride, monosodium glutamate monohydrate and water for injections.

What Fluenz looks like and contents of the pack

This vaccine is presented as a nasal spray suspension (0.2 ml) in a single -use nasal applicator (Type 1 glass). Pack size of 1 and 10 nasal applicators . 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 85 Södertälje Sweden 25 Manufacturer AstraZeneca Nijmegen B.V. , Lagelandseweg 78 Nijmegen, 6545CG Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Тел.: +359 24455000 Luxembourg/Luxemburg AstraZeneca S .A./N.V.

Tél/Tel: +32 2 370 48 11 Česká republika AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111 Magyarország AstraZeneca Kft .

Tel.: +36 1 883 6500 Danmark AstraZeneca A/S Tlf.: +45 43 66 64 62 Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Deutschland AstraZeneca GmbH Tel: + 49 40 809034100 Nederland AstraZeneca BV Tel: +31 85 808 9900 Eesti AstraZeneca Tel: +372 6549 600 Norge AstraZeneca AS Tlf: +47 21 00 64 00 Ελλάδα AstraZeneca A.E.

Τηλ: +30 210 6871500 Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 España AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00 Polska AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00 France AstraZeneca Tél: +33 1 41 29 40 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00 Hrvatska AstraZeneca d.o.o.

Tel: +385 1 4628 000 România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor hf.

Sími: +354 535 7000 Slovenská republika AstraZeneca AB , o.z.

Tel: +421 2 5737 7777 26 Italia AstraZeneca S.p.A.

Tel: + 39 02 00704500 Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρμακευτική Λτδ Τηλ: +357 22490305 Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca Latvija Tel: +371 67377100 This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ——————————————————— ————————————————————— Instructions for healthcare professionals

🩺 Information intended for healthcare professionals only

Fluenz is for single nasal use only.

• Do not use with a needle. Do not inject.
• Do not use Fluenz if the expir y date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the nasal applicator or if there are any signs of leakage.
• Check the appearance of the vaccine before administration. The suspension should be colourless to pale yellow, clear to opalescent. Small white particles may be present.
• Fluenz is administered as a divided dose in both nostrils as described below (see section 3).
• After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
• The patient can breathe normally while the vaccine is being administered – there is no need to actively inhale or sniff.

Nozzle tip protector Plunger stopper Dose -divider clip Plunger rod Check expiry date Product must not be used after date on applicator label. Prepare the applicator Remove nozzle tip protector. Do not remove dose-divider clip at the other end of the applicator. Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure Fluenz is delivered into the nose.

Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose -divider clip prevents you from going further. Remove dose -divider clip For administration in the other nostril, pinch and remove the dose -divider clip from plunger. Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.

See section 5 for advice on storage and disposal.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Fluenz (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1816).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.