Fluenz nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluenz nasal spray suspension

Influenza vaccine (live, nasal)

Read this entire leaflet carefully before the vaccine is administered, as it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, nurse, or pharmacist.
• This vaccine has been prescribed for you or your child only and must not be given to other people.
• If you experience any adverse effects, talk to your doctor, nurse, or pharmacist. This includes any possible adverse effects not mentioned in this leaflet. See section 4.

Leaflet contents:

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 adverse 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 used to prevent influenza. It is used in children and adolescents over 2 years of age and under 18 years of age. Fluenz will help protect against the virus strains contained in the vaccine and other closely related strains.

How Fluenz works

When the vaccine is given to a person, the immune system (the body's natural defence system) produces its own protection against the influenza virus. None of the components of the vaccine can cause influenza.

The viruses in Fluenz vaccine are grown in hens' eggs. Each year, the vaccine provides protection against three influenza strains, in accordance with 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 to you:

• if you are allergic to the active substances, gentamicin (trace residues from the manufacturing process), or to any of the other components of this vaccine listed in section 6.
• if you have ever had a severe allergic reaction to eggs or egg proteins. For information about the signs of allergic reactions, see section 4.
• if you have a blood disorder or cancer affecting the immune system.
• if your doctor has told you that you have a weakened immune system due to illness, medication, or other treatment (such as acute or chronic leukemias, lymphoma, symptomatic HIV infection, cellular immunodeficiencies, or high-dose corticosteroid therapy).
• if you are already taking acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever). This is due to the risk of 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

Your doctor or nurse will ensure that appropriate medical treatment and supervision are available in case a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) occurs after administration.

Inform 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 congestion. Your doctor may decide to delay vaccination until the fever or nasal congestion has resolved.
• if you have close contact with someone who has a severely weakened immune system (for example, a bone marrow transplant patient requiring isolation).
• if you have an uncorrected congenital defect affecting the bones and tissues of the skull and face.

If any of these conditions apply to you, inform your doctor, nurse, or pharmacist before vaccination. They will decide whether Fluenz is suitable for you.

Children under 2 years of age

Children under 2 years of age should not receive this vaccine due to the risk of adverse effects.

Other medicines, other vaccines, and Fluenz

Inform your doctor, nurse, or pharmacist if the person being vaccinated is taking, has recently taken, or might need to take any other medicines, including medicines not requiring a prescription.

• Do not give 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 your doctor, nurse, or pharmacist advises otherwise. This is due to the risk of Reye's syndrome, a very rare but serious illness that can affect the brain and liver.
• It is recommended not to administer Fluenz at the same time as antiviral medications such as oseltamivir and zanamivir. This is because the vaccine may be less effective.

Your doctor, nurse, or pharmacist will decide whether Fluenz can be given at the same time as other vaccines.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor, nurse, or pharmacist before using this vaccine. Fluenz is not recommended for pregnant or breastfeeding women.

Driving and using machines

• The effect of Fluenz on the ability to drive and operate machinery is negligible or none.

3. How Fluenz is administered

Fluenz must only be used as a nasal spray.

Fluenz must not be injected.

Fluenz will be administered as a spray into each nostril. You can breathe normally while Fluenz is being given. It is not necessary to inhale or sniff actively.

Dosage

The recommended dose for children and adolescents is 0.2 ml of Fluenz, administered as 0.1 ml into each nostril. Children aged 2 to 8 years who have not previously been vaccinated against influenza will receive a second follow-up dose after a minimum interval of 4 weeks. Follow your doctor's, nurse's or pharmacist's instructions regarding whether your child should return for the second dose and when.

If you have any further questions about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone experiences them.

Consult your doctor, nurse, or pharmacist if you would like more information about the possible side effects of Fluenz.

Some side effects may be serious.

Very rare (may affect up to 1 in 10,000 people)

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

Inform your doctor immediately or seek urgent medical attention if you notice any of these symptoms.

Other possible side effects of Fluenz

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

• blocked or runny nose
• decreased appetite
• general malaise

Common (may affect up to 1 in 10 people)

• fever
• muscle aches
• headache

Uncommon (may affect up to 1 in 100 people)

• skin rash
• nosebleeds
• allergic reactions

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the outer carton following the letters EXP/EXP.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the nasal applicator in the outer packaging to protect it from light.

Before use, the vaccine may be removed from the refrigerator once for a maximum period of 12 hours at a temperature up to 25 °C. If not used within this 12-hour period, the vaccine must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluenz

The active substances are:

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

…….......................................................................................................per 0.2 ml dose

• Multiplied in fertilized chicken eggs from healthy henhouses.

** Produced in VERO cells using reverse genetic technology. This product contains genetically modified organisms (GMOs).

*** Fluorescent Focus Units (FFU)

This vaccine complies with the WHO (World Health Organization, Northern Hemisphere) recommendation and 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 other components are sucrose, potassium hydrogen phosphate, potassium dihydrogen phosphate, gelatin, arginine hydrochloride, monosodium glutamate monohydrate, and water for injection.

Appearance of Fluenz and contents of the pack

This vaccine is presented as a nasal spray suspension (0.2 ml) in a single-use nasal applicator (Type I glass) in pack sizes of 1 and 10 nasal applicators. Only certain pack sizes may be available in your country.

The suspension is colorless to slightly yellow, clear to slightly cloudy. It may contain small white particles.

Marketing Authorization Holder

AstraZeneca AB,

SE-151 85

Södertälje

Sweden

Manufacturer

AstraZeneca Nijmegen B.V.,

Lagelandseweg 78

Nijmegen, 6545 CG

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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Instructions for healthcare professionals

This information is intended for healthcare professionals only:

Fluenz is for intranasal use only.

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

• Do not use Fluenz if the expiry date has passed or if the applicator is 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 and from 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 of the dose into one nostril, administer the other half of the dose into the other nostril immediately or shortly afterwards.
• The patient may breathe normally during administration; there is no need to inhale or actively sniff through the nose.

See section 5 for information about storage and disposal