Fluenz

Patient information leaflet: Information for the user

Fluenz nasal spray, suspension

Influenza vaccine (live, nasal)
Please read all of this leaflet carefully before the vaccine is administered, as it contains
important information for you or for the child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This vaccine has been prescribed only for you or for the child. Do not give it to others.
• If any side effects occur, talk to your doctor, nurse or pharmacist. These may include side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Fluenz is and what it is used for

Fluenz is a vaccine that prevents influenza. It is used in children and adolescents aged between 2 and 18 years. Fluenz helps protect against the viral strains contained in the vaccine and against other closely related strains.
How Fluenz works
When a person receives the vaccine, the immune system (the body's natural defence system) produces antibodies against the influenza virus. No component of the vaccine can cause influenza.
The viruses contained in Fluenz vaccine are cultivated in chicken eggs. Each year the vaccine is directed against three influenza virus strains, based on the annual recommendations of the World Health Organization.

2. What you need to know before Fluenz is administered to you

Fluenz will not be given if the person:

• is allergic to the active substances, to gentamicin (trace residues from the manufacturing process), or to any of the excipients of this vaccine listed in section 6.
• has ever had a severe allergic reaction to eggs or egg proteins. For symptoms of allergic reactions, see section 4.
• has a blood disorder or a tumour affecting the immune system.
• has been told by a doctor that they have a weakened immune system due to a disease, medication, or other treatment (such as acute or chronic leukaemias, lymphoma, symptomatic HIV infection, cellular immunodeficiencies, or high-dose corticosteroids).
• is taking acetylsalicylic acid (a substance found in many medicines, used to relieve pain and reduce fever). This is due to the risk of developing a very rare but serious illness (Reye's syndrome).

If any of these conditions apply to you, inform your doctor, nurse, or pharmacist.
Warnings and precautions
The doctor or nurse will ensure that medical treatment and adequate supervision are readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid heartbeat, and skin rash) following administration.
Talk to your doctor, nurse, or pharmacist before vaccination:

• if you have severe asthma or are currently experiencing wheezing.
• if you have a serious acute illness with fever or infection, or if you have nasal obstruction. Your doctor may decide to delay vaccination until the fever or nasal obstruction has resolved.
• if you are in close contact with someone whose immune system is severely weakened (for example, a patient who has received a bone marrow transplant and needs to remain in isolation).
• if you have congenital defects affecting the bones and tissues of the skull and face that have not been surgically corrected.

If any of these conditions apply to you, inform your doctor, nurse, or pharmacist before
being vaccinated. They will decide whether Fluenz is suitable for you.
Children under 2 years of age
Children under 2 years of age must not receive this vaccine due to the risk of side effects.
Other medicines, other vaccines, and Fluenz
Inform your doctor, nurse, or pharmacist if the person to be vaccinated is taking, has recently taken, or might take any other medicines, including medicines without a prescription.

• Do not administer acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever) to children for 4 weeks after vaccination with Fluenz, unless otherwise decided by the doctor, nurse, or pharmacist. This is due to the risk of Reye's syndrome, a very rare but serious disease affecting the brain and liver.
• Fluenz must not be taken at the same time as other antiviral medicines specifically for influenza, such as oseltamivir and zanamivir. The vaccine may be less effective.

The doctor, nurse, or pharmacist will decide whether Fluenz can be administered together with other
vaccines.
Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, nurse, or pharmacist before receiving this vaccine. Fluenz is not recommended for pregnant or breastfeeding women.

Driving and using machines

• Fluenz does not affect or has negligible influence on the ability to drive or operate machinery.

3. How Fluenz is administered

Fluenz must be used exclusively as a nasal spray.
Fluenz must not be injected.
Fluenz will be administered as one spray into each nostril. You can breathe normally while
Fluenz is being administered. It is not necessary to inhale or breathe in actively.
Dose
The recommended dose for children and adolescents is 0.2 mL of Fluenz, administered as 0.1 mL per nostril. Children aged 2 to 8 years who have not previously received an influenza vaccine will receive a second follow-up dose 4 weeks after the first dose. Follow the instructions provided by the doctor, nurse, or pharmacist regarding whether and when the child should return for the second dose.
If you have any questions about this vaccine, consult the doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them.
Ask your doctor, nurse or pharmacist if you want more information about the possible side effects of Fluenz.
Some of these side effects can be serious
Very rare (may affect 1 in 10,000 people)

• severe allergic reaction: signs of a severe allergic reaction may include difficulty breathing and swelling of the face or tongue.

If you experience any of the side effects listed above, seek medical advice immediately or get urgent medical help.
Other possible side effects of Fluenz
Very common (may affect more than 1 in 10 people)

• runny or blocked nose
• loss of appetite
• general feeling of being unwell

Common (may affect up to 1 in 10 people)

• fever
• muscle pain
• headache

Uncommon (may affect up to 1 in 100 people)

• skin rash
• nosebleed
• allergic reactions

Reporting of side effects
If you experience any side effect , including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the label of the applicator and on the
carton after the letters EXP.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the nasal applicator in the outer packaging to protect it from light.
Before use, the vaccine may be kept outside the refrigerator for a maximum of 12 hours at a temperature
not exceeding 25 °C. After 12 hours, the vaccine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluenz contains
The active substances are:
Recombinant influenza virus (live attenuated) from the following three strains**:
A/Similar to Victoria/4897/2022 (H1N1)pdm09 strain
(A/ Norway/31694/2022, MEDI 369815) 10 FU***
A/Similar to Croatia/10136RV/2023 (H3N2) strain
(A/ Perth/722/2024, MEDI 392611) 10 FU***
B/Similar to Austria/1359417/2021 strain
(B/ Austria/1359417/2021, MEDI 355292) 10 FU***
......................................................................................................................per 0.2 mL dose
* Propagated in fertilized hens' eggs from healthy flocks.
** Produced in VERO cells using reverse genetics. The product contains genetically modified organisms (GMOs).
*** Fluorescent Units
The vaccine complies with the recommendations (Northern Hemisphere) of the World Health Organization (WHO) and with the European Union decision for the 2025/2026 season.
The vaccine may contain traces of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The excipients are sucrose, dipotassium phosphate, monopotassium phosphate, gelatine, arginine hydrochloride, monosodium glutamate monohydrate and water for injections.

Description of the appearance of Fluenz and contents of the pack
The vaccine is a nasal spray suspension (0.2 mL) contained in a single-use nasal applicator (Type I glass). Packs of 1 or 10 nasal applicators. Not all pack sizes may be marketed in your country.
The suspension ranges from colourless to pale yellow, clear or slightly opaque. Small white particles may be present.

Marketing Authorisation Holder
AstraZeneca AB,
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

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

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρμακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

Instructions for healthcare professionals
The following information is intended exclusively for healthcare professionals:
Fluenz is for single-use nasal administration only.

• Do not use with a needle. Do not inject.

• Do not use Fluenz after the expiry date or if the atomizer appears damaged, for example if the plunger rod is loose or removed from the nasal applicator, or if there are 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 into both nostrils as described below (see section 3).
• After administering half the dose into one nostril, administer the other half into the other nostril immediately or shortly afterwards.
• The patient may breathe normally during vaccine administration; active inhalation is not required.

Dose-divider clip
Plunger cap
Dose-divider clip
Applicator tip protector
Plunger rod

Check expiry date Prepare the applicator Position the applicator
Remove the tip protector from the dispenser. Do not remove the dose-divider clip from the applicator. With the patient in an upright position, insert the tip just inside one nostril to ensure delivery of Fluenz into the nose.

Press the plunger Remove the dose-divider clip Spray into the other nostril
With a single, rapid movement, press the plunger until the dose-divider clip prevents further movement. For administration into the other nostril, insert the tip just inside the other nostril and, with a single, rapid movement, press the plunger to deliver the remaining vaccine.
See section 5 for advice on storage and disposal.