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AstraZeneca

Fluenz
influenza vaccine (live attenuated, nasal)

Package Leaflet: Information for the user


Fluenz nasal spray suspension

Influenza vaccine (live attenuated, nasal)


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This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.



What is in this leaflet:


  1. What Fluenz is and what it is used for

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

  3. How Fluenz is given

  4. Possible side effects

  5. How to store Fluenz

    Medicinal product no longer authorised

  6. Contents of the pack and other information


  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 24 months to less than 18 years of age.


    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. The vaccine targets three strains of influenza virus each year, 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 eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”). 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 under 18 years of age and 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 is suitable for you.


      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.

    • Do not give acetylsalicylic acid to children aged less than 18 years 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. 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

      Medicinal product no longer authorised

    • 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.


  3. How Fluenz is given


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


    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.


    Dosage

    • The recommended dose for children and adolescents is 0.2 ml Fluenz, 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 when your child should return for the second dose.


  4. Possible side effects


    Like all medicines, Fluenz 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 1,000,000 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

    • weakness

    • headache


      Common

      (may affect up to 1 in 10 people):

    • fever

    • muscle aches


      Uncommon

      (may affect up to 1 in 100 people):

    • rash

      Medicinal product no longer authorised

    • nose bleed

    • allergic reactions


      Reporting of side effects

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      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 Fluenz 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.

    Protect from light.


    Before use, the vaccine may be taken out of the refrigerator, without being replaced, 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 disposed of.


    Any unused product or waste material should be disposed of in accordance with local requirements for medical waste. 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 strains**:


A/California/7/2009 (H1N1)pdm09-like strain

(A/California/7/2009, MEDI 228029) 107.0±0.5 FFU***


A/Victoria/361/2011 (H3N2)-like strain

(A/Texas/50/2012, MEDI 237514) 107.0±0.5 FFU***


B/Massachusetts/2/2012-like strain

(B/Massachusetts/2/2012, MEDI 237751) 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 2013/2014 season.


Medicinal product no longer authorised

The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), 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 in a single-use nasal applicator (0.2 ml) in a pack size of 10.


The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy. Small white particles may be present.


Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Netherlands, (Tel) +31 24 371 7310


Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK

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


België/Belgique/Belgien NV AstraZeneca SA Tel: +32 2 370 48 11

Lietuva

UAB ,,AstraZeneca Lietuva“ Tel: +370 5 2660550


България

ТП AstraZeneca UK Limited

Тел.: +359 2 971 25 33

Luxembourg/Luxemburg NV AstraZeneca SA Belgique/Belgien

Tél/Tel: +32 2 370 48 11


Česká republika

AstraZeneca Czech Republic s.r.o. Tel: +420222807111

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 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222


Eesti

AstraZeneca Eesti OÜ Tel: +372 6549 600

Norge

AstraZeneca AS Tlf: +47 21 00 64 00


Ελλάδα

Medicinal product no longer authorised

AstraZeneca A.E.

Τηλ: +30 2 106871500

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 22 874 35 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) Ltd 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


Italia

AstraZeneca S.p.A. Tel: +39 02 98011

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 AB Latvija Tel: +371 67321747

United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836


This leaflet was last revised in.


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Fluenz is a trademark of MedImmune, LLC.


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Instructions for health professionals


The following information is intended for medical or healthcare professionals only:


Fluenz is for nasal use only.


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Check expiry date

Product must be used before date on applicator label.

Prepare the applicator

Remove rubber 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.

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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

Medicinal product no longer authorised

rapidly as possible to deliver remaining vaccine.


See section 5 for advice on storage and disposal.