Author: MedImmune LLC


Long information

What is it and how is it used?

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.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

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 (theseare listed in section 6 ?Further Information?). For signs of allergic reactions, see section 4 ?Possible side effects?.
  • if you havea 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.

Take special care with Fluenz

Tell your doctor, nurse or pharmacist:

  • if the child is less than24 months of age 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.

Using other medicines and other vaccines
Tell your doctor, nurse or pharmacist if the person being vaccinated is taking or has recently taken any other medicines, including medicines that do not require a prescription.

  • 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.
  • It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines.

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 (or think you might be) or breast-feeding, tell your doctor, nurse or pharmacist.Fluenz is not recommended for women who are pregnant or are breast-feeding.

How is it used?

A doctor, nurse or pharmacist will administer Fluenz.

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.

What are 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.

Very common

(affects more than 1 user in 10):

  • runny or stuffy nose
  • reduced appetite
  • weakness
  • headache

Common

(affects 1 to 10 users in 100):

  • fever
  • muscle aches

Uncommon

(affects 1 to 10 users in 1,000):

  • rash
  • nose bleed
  • allergic reactions: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist.

How should it be stored?

Keep out of the reach and sight 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.

Any unused product or waste material should be disposed of in accordance with local requirements for medical waste. Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Fluenz contains

The active substances are Reassortant influenza virus live attenuated of the following strains 107.00.5AOfficial strain H1N1 like strain actual strain AOfficial strain H3N2 like strain actual strain BOfficial strain like strain actual strain 107.00.5107.00.5 FFU FFU 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 20XX/20XX season.

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 pack sizes of 1 and 10. Not all pack sizes may be available in your country.

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:

BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11

AstraZeneca UK Limited . 359 2 971 25 33 Magyarország AstraZeneca Kft Tel. 36 1 883 6500

eská republika AstraZeneca Czech Republic s.r.o. Tel 420222807111 Malta Associated Drug Co. Ltd Tel 356 2277 8000

Danmark AstraZeneca AS Tlf 43 66 64 62 Nederland AstraZeneca BV Tel 31 79 363 2222

Deutschland AstraZeneca GmbH Tel 49 41 03 7080 Norge AstraZeneca AS Tlf 47 21 00 64 00

Eesti AstraZeneca Eesti OÜ Tel 372 6549 600 Österreich AstraZeneca Österreich GmbH Tel 43 1 711 31 0

AstraZeneca A.E. 30 2 106871500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel. 48 22 874 35 00

España AstraZeneca Farmacéutica Spain, S.A. Tel 34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel 351 21 434 61 00

France AstraZeneca Tél 33 1 41 29 40 00 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 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010

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

Lietuva

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

This leaflet was last approved in {MM/YYYY}.

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.

  • Do not use with a needle. Do not inject.
  • Fluenz is administered as a divided dose in both nostrils as described below. (See also, How Fluenz is given, in 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.

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. Remove dose-divider clip For administration in the other nostril, pinch and remove the dose-divider clip from plunger. Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further. 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

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