Fluenz suspension para pulverizacion nasal

Prospect: information for the user

Fluenz nasal suspension for inhalation

Influenza vaccine (live attenuated, nasal)

Read this prospect carefully before administering the vaccine, as it contains important information for you or your child.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse, or pharmacist.
• This vaccine has been prescribed only for you or your child and should not be given to other people.
• If you consider that any of the adverse effects you are experiencing are severe, consult your doctor, nurse, or pharmacist. This includes any possible adverse effect not mentioned inthisprospect. See section4.

1.What is Fluenz and for what it is used

2.What you need to know before administering Fluenz

3.How to administer Fluenz

4.Possible adverse effects

5.Storage of Fluenz

6.Contents of the package and additional information

Fluenz is a vaccine to prevent the flu. It is used in children and adolescents over24months andless than18years. Fluenz will help protect you from the virus strains contained in the vaccine and other closely related strains.

How Fluenz works

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

The Fluenz virus strains are grown in chicken eggs. Each year, the vaccine acts against three flu strains, following the annual recommendations of the World Health Organization.

You will not be given Fluenz:

• if you are allergicto gentamicin, gelatin orany of the other components of this vaccine (these are listed in the section6“Contents of the package and additional information”).
• if you have ever had asevere allergic reactionto eggs or egg proteins. To know the signs of allergic reactions, see the section4“Possible side effects”.
• if you have ablood disorderor acancerthataffects the immune system.
• ifyour doctor has toldyou that you havea weakened immune systemas a result ofan illness, medication or other treatment.
• if you are already takingaspirin(a substance present in many medications used to relieve pain and reduce fever).This is due to the risk of a rare but seriousReye's syndrome.

If any of these conditions apply to you,inform your doctor, nurse or pharmacist.

Warnings and precautions

Inform your doctor, nurse or pharmacist before vaccination:

• if thechild is less than24monthsold. Children under24months old should not be vaccinated due to the risk of side effects.
• if you havesevere asthmaor are currently experiencing wheezing.
• if you are inclose contact with someone who has a severely weakened immune system(for example, a bone marrow transplant patient who requires isolation).

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

Other medications, other vaccines and Fluenz

Inform your doctor, nurse or pharmacist if the person being vaccinated is using, has recently used or mayhave touse any other medication, including medications that do not require a prescription.

• Do not administeraspirin(a substance present in many medications used to relieve pain and reduce fever)to childrenfor4weeks aftervaccination with Fluenz unless your doctor, nurse or pharmacist advises otherwise. This is due to the risk of Reye's syndrome, a rare butserious disease that can harm the brain and liver.
• It is recommended not to administer Fluenzat the same time asantiviral medicationssuch asoseltamivirandzanamivir. This is because the vaccine may lose its effectiveness.

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

Pregnancy and breastfeeding

• if you arepregnant, think you may be pregnant, intend to become pregnant orare breastfeeding, consult your doctor,nurse or pharmacistbefore using this vaccine. Fluenzis not recommendedfor pregnant women or those breastfeeding.

Driving and operating machinery

• The influence of Fluenz on the ability to drive and operate machinery is negligible orinsignificant.

Fluenz will be administered under the supervision of a doctor, nurse, or pharmacist.

Fluenz should only be used as a nasal spray.

Fluenz should not be injected.

Fluenz will be administered as a spray into each nasal cavity. You can breathe normally while Fluenz is being administered. There is no need to inhale or actively aspirate.

Dosage

The recommended dosefor children and adolescents is0.2ml of Fluenz, administered at a rate of0.1ml into each nasal cavity.Children who have not been vaccinated against the fluwill receive a second dose offollow-up after a minimum interval of4weeks. Follow the instructions of your doctor, nurse, or pharmacist regarding whether your child should attend for the second dose and when.

If you have any other questions about the use of this medication, ask your doctor, nurse, orpharmacist.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them. In clinical studies conducted with this vaccine, most side effects were brief and of mild nature.

Consult your doctor, nurse, or pharmacist if you wish to learn more about the possible side effects of Fluenz.

Some side effects may be serious.

Very rare

(may affect up to1in every10,000people)

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

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

Other possible side effects of Fluenz

Very common

(may affect more than1in every10people):

• stuffy nose or runny nose
• loss of appetite
• weakness

Common

(may affect up to1in every10people):

• fever
• muscle aches
• headache

Uncommon

(may affect up to1in every100people):

• skin rash
• nasal bleeding
• allergic reactions

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you cancontribute to providing more information about the safety of this medicine.

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiration date that appears on the applicator label after the letters EXP.

Store in the 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 can be removed from the refrigerator once during a maximum period of 12 hours at a temperature of up to 25°C. If not used after this 12-hour period, the vaccine must be discarded.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Fluenz

The active principles are:

Influenza virus reaggregated* (live attenuated) from the following strains:

Strain similar to A/ Victoria/4897/2022 (H1N1)pdm09

(A/ Norway/31694/2022, MEDI 369815)107.0±0.5UFF***

Strain similar to A/ Thailand/8/2022 (H3N2)

(A/ Thailand/8/2022, MEDI 370626)107.0±0.5UFF***

Strain similar to B/ Austria/1359417/2021

(B/ Austria/1359417/2021, MEDI 355292)107.0±0.5UFF***

.......................................................................................................for a dose of0.2ml

*multiplied in fertilized chicken eggs from healthy chicken farms.

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

***Units of Fluorescent Foci

This vaccine meets the WHO (World Health Organization, Northern Hemisphere) recommendation and the EU decision for the 2024/2025 season.

The other components are sucrose, potassium dihydrogen phosphate, dihydrogen potassium phosphate, gelatin (pig, Type A), arginine chloride, monosodium glutamate monohydrate, and water for injection.

Appearance of Fluenz and packaging contents

This vaccine is presented in a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a packaging size of 1 and 10 units. Only some packaging sizes may be available in your country.

The suspension is colorless to pale yellow, transparent to slightly turbid. It may present small white particles.

Marketing Authorization Holder

AstraZeneca AB,

SE-151 85 Södertälje,

Sweden

Responsible for manufacturing

AstraZeneca Nijmegen B.V.,

Lagelandseweg 78

Nijmegen, 6545CG

Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Last review date of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

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