PANDEMIC INFLUENZA VACCINE H5N1 ASTRAZENECA NASAL SPRAY SUSPENSION

Introduction

Package Leaflet: Information for the User

Pandemic influenza vaccine H5N1 AstraZeneca nasal spray suspension

Pandemic influenza vaccine (H5N1) (live attenuated, nasal)

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This vaccine has been prescribed for you or your child. Do not pass it on to others.
• If you think any of the side effects mentioned in this leaflet are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for
2. What you need to know before Pandemic influenza vaccine H5N1 AstraZeneca is given
3. How Pandemic influenza vaccine H5N1 AstraZeneca is given
4. Possible side effects
5. Storing Pandemic influenza vaccine H5N1 AstraZeneca
6. Contents of the pack and other information

1. What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for

Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent influenza in the event of an officially declared pandemic. It is used in children and adolescents from 12 months up to less than 18 years of age.

Pandemic influenza is a type of influenza that occurs at intervals of less than 10 years to several decades. It spreads rapidly around the world. The signs of pandemic influenza are similar to those of ordinary influenza but can be more severe.

How Pandemic influenza vaccine H5N1 AstraZeneca works

Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine that contains four strains), except that Pandemic influenza vaccine H5N1 AstraZeneca provides protection against a single strain in an officially declared pandemic situation.

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

The vaccine virus in Pandemic influenza vaccine H5N1 AstraZeneca is grown in chicken eggs. The influenza strain used in the vaccine in an officially declared pandemic situation is the one recommended by the World Health Organization.

2. What you need to know before Pandemic influenza vaccine H5N1 AstraZeneca is given

Pandemic influenza vaccine H5N1 AstraZeneca must not be given to:

• If you have had a severe allergic reaction(i.e. potentially life-threatening) to eggs, egg proteins, gentamicin, gelatin or any of the other components of this vaccine(listed in section 6 "Contents of the pack and other information"). For signs of allergic reactions, see section 4 "Possible side effects". However, in a pandemic situation, your doctor may recommend that you are given the vaccine, provided that medical treatment is available immediately in case of an allergic reaction.

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

Warnings and precautions

Tell your doctor, nurse or pharmacist before vaccination:

• . Children less than 12 months old must not be vaccinated due to the risk of side effects.
• If you have had any allergic reaction other than a sudden and potentially life-threatening allergic reactionto eggs, egg proteins, gentamicin, gelatin or any of the other components of this vaccine(listed in section 6 "Contents of the pack and other information").
• (a substance present in many medicines used to relieve pain and lower fever). This is due to the risk of a very rare but serious disease (Reye's syndrome).
• .
• due to a disease, medicine or other treatment.
• or are currently wheezing.
• (e.g. a bone marrow transplant patient who needs isolation).

If any of these conditions apply to you, tell your doctor, nurse or pharmacist before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.

Using Pandemic influenza vaccine H5N1 AstraZeneca with other medicines and other vaccinesTell your doctor, nurse or pharmacist if the person to be vaccinated is using, has recently used or might use any other medicines, including medicines that do not require a prescription.

• Do not give acetylsalicylic acid(a substance present in many medicines used to relieve pain and lower fever) to childrenfor 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise. This is due to the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
• Pandemic influenza vaccine H5N1 AstraZeneca should not be givenat the same time as antiviral medicines against influenzasuch as oseltamivirand zanamivir. This is because the vaccine may lose its effect.

Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.

Pregnancy and breast-feeding

• If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.
• Pandemic influenza vaccine H5N1 AstraZeneca is not recommendedin breast-feeding women.

Driving and using machines

• The influence of Pandemic influenza vaccine H5N1 AstraZeneca on the ability to drive and use machines is negligible.

3. How Pandemic influenza vaccine H5N1 AstraZeneca is given

Pandemic influenza vaccine H5N1 AstraZeneca will be given under the supervision of a doctor, nurse or pharmacist.

Pandemic influenza vaccine H5N1 AstraZeneca should only be used for nasal spray.

Pandemic influenza vaccine H5N1 AstraZeneca must not be injected.

Pandemic influenza vaccine H5N1 AstraZeneca will be given as a spray in each nostril. You can breathe normally while Pandemic influenza vaccine H5N1 AstraZeneca is being given. You do not need to inhale or sniff.

Dose

The recommended dosefor children and adolescents is 0.2 ml of Pandemic influenza vaccine H5N1 AstraZeneca, given as 0.1 ml in each nostril. All childrenwill receive a second follow-up dose at least 4 weeks after the first dose.

If you have any further questions on 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 everybody gets them. In clinical studies with this vaccine, most side effects were short-lived and mild.

Ask your doctor, nurse or pharmacist for more information on the possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca.

Some side effects may be serious:

Very rare

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

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

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

In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and infection of the upper respiratory tract (inflammation of the nose, throat and sinuses).

Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents:

Very common

(may affect more than 1 in 10 people):

• stuffy or runny nose
• loss of appetite
• weakness

Common

(may affect up to 1 in 10 people):

• fever
• muscle pain
• headache

Uncommon

(may affect up to 1 in 100 people):

• skin rash
• nosebleeds
• allergic reactions

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. Storing Pandemic influenza vaccine H5N1 AstraZeneca

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

Do not use this vaccine after the expiry date which is stated on the label of the applicator after 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.

Medicines 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 protect the environment.

6. Container contents and additional information

Composition of Pandemic influenza vaccine H5N1 AstraZeneca

The active substance is:

Reassorted influenza virus* (live attenuated) of the following strain**:

Strain A/Vietnam/1203/2004 (H5N1)

(A/Vietnam/1203/2004, MEDI 0141000136) 107.0±0.5 FFU***

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

• multiplied in fertilized chicken eggs from healthy chicken coops.

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

*** fluorescent focus units

This vaccine complies with the WHO recommendation and the EU decision for the pandemic.

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

Appearance of Pandemic influenza vaccine H5N1 AstraZeneca and container contents

This vaccine is presented as a suspension for nasal spray in a single-use nasal applicator (0.2 ml) in a pack size of 10 units.

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

Manufacturer

AstraZeneca Nijmegen B.V.,

Lagelandseweg 78

Nijmegen, 6545CG

Netherlands

MedImmune, UK Limited,

Plot 6, Renaissance Way,

Boulevard Industry Park,

Speke,

Liverpool L24 9JW,

United Kingdom

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet: MM/YYYY

This medicinal product has been authorized with a «conditional approval». This approval mechanism means that further information on this medicinal product is awaited. The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.

Instructions for healthcare professionals

This information is intended solely for healthcare professionals:

Pandemic influenza vaccine H5N1 AstraZeneca must be used by the nasal route only.

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

• Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiration date has expired or if the sprayer is damaged, for example if the plunger is loose or displaced from the sprayer or if there is any sign of loss of content.
• Check the appearance of the vaccine before administration. The suspension should be colorless to pale yellow, transparent to opalescent. It may present small white particles.
• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nasal cavities as described below. (See also How to administer Pandemic influenza vaccine H5N1 AstraZenecain section 3).
• After administering half of the dose in one nasal cavity, administer the other half of the dose in the other nasal cavity immediately or shortly after.
• The patient can breathe normally while the vaccine is being administered; there is no need to inhale or aspirate actively through the nose.

See section 5for information on storage and disposal.