Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) - patient leaflet, side effects, dosage

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 (flu) in an officially declared pandemic. It is used in children and adolescents 12 months to less than 18 years of age.

Pandemic flu is a type of influenza thathappens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

How Pandemic influenza vaccine H5N1 AstraZeneca works

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

Wen 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 te flu.

Pandemic influenza vaccine H5N1 AstraZeneca vaccine virus is grown in chicken eggs. The influenza strain used for the vaccine in an offically declared pandemic is recommended by the World Health Organisation.

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

You should not be given Pandemic influenza vaccine H5N1 AstraZeneca:

• if you have previously had a serious allergic reaction (i.e. life-threatening) to eggs, egg

proteins, gentamicin, or gelatin or any of the other ingredients 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 to give you the vaccine provided that appropriate medical treatement is immediately available in case of an allergic reaction.

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 12 months of age. Children less than 12 months of age should not

receive this vaccine because of the risk of side effects.

• if you have had any allergic reaction other than a sudden life-threatening allergic reaction

to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).

• if you are 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 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 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 Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.

Other medicines, other vaccines and Pandemic influenza vaccine H5N1 AstraZeneca

Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take 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 children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca 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 Pandemic influenza vaccine H5N1 AstraZeneca is not given at the

same time as influenza-specific antiviral medicines such as oseltamivir and zanamivir. This is because the vaccine may work less effectively.

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, think you may be pregnant, or plan to become pregnant soon, tell your

doctor, nurse or pharmacist before vaccination. He or she will decide if Pandemic influenza vaccine H5N1 AstraZeneca is suitable for you.

• Pandemic influenza vaccine H5N1 AstraZeneca is not recommended for breast-feeding

women.

Driving and using machines

• Pandemic influenza vaccine H5N1 AstraZeneca has no or negligible influence on the ability to drive and use machines.

• 3. How Pandemic influenza vaccine H5N1 AstraZeneca is given

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

Pandemic influenza vaccine H5N1 AstraZeneca must only be used as a 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 you are given Pandemic influenza vaccine H5N1 AstraZeneca. You do not need to actively inhale or sniff.

Dosage

The recommended dose for children and adolescents is 0.2 ml Pandemic influenza vaccine H5N1 AstraZeneca, administered as 0.1 ml in each nostril. All children will receive a second, follow-up dose after an interval of at least 4 weeks.

If you have any further questions on this vaccine, 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 the vaccine, most side effects were mild in nature and short-term.

Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Pandemic influenza vaccine H5N1 AstraZeneca.

Some side effects may be serious:

Very rare

(may affect up to 1 in 10,000 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 straightaway or seek urgent medical care if you experience any of the effects above.

In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and upper respiratory tract infection (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):

• runny or stuffy nose
• reduced appetite
• weakness

Common

(may affect up to 1 in 10 people):

• fever
• muscle aches
• headache

Uncommon

(may affect up to 1 in 100 people):

• rash
• nose bleed
• allergic reactions

Reporting of side effects

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 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 applicator label after the letters EXP.

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

Keep the nasal applicator in the outer carton in order to protect from light.

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 Pandemic influenza vaccine H5N1 AstraZeneca contains

The active substance is:

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

A/Vietnam/1203/2004 (H5N1) strain

(A/Vietnam/1203/200­4, MEDI 0141000136) 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 a genetically modified organism (GMO).

• * ** fluorescent focus units

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

The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.

What Pandemic influenza vaccine H5N1 AstraZeneca 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 colourless to pale yellow, clear to slightly cloudy. Small white particles may be present.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Efcnrapua

AcTpa3eHeKa Etnrapua EOOfl

Ten: +359 24455000

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Deutschland

AstraZeneca GmbH

Tel: +49 41 03 7080

Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EXXáSa AstraZeneca A.E. Tql: +30 2–10 6871500	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 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 3176041
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
Kúnpog AXéKTop OappaKsuTiK^ At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000
Latvija SIA AstraZeneca Latvija Tel: +371 67377100	United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in {MM/YYYY}

This medicine has been given “conditional approval”. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

.

Instructions for healthcare professionals

The following information is intended for healthcare professionals only:

Pandemic influenza vaccine H5N1 AstraZeneca is for nasal use only.

• Do not use with a needle. Do not inject.
• Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiry date has passed or the

sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.

• Check the appearance of the vaccine before administration. The suspension should be colourless

to pale yellow, clear to opalescent. Small white particles may be present.

• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both

nostrils as described below. (See also How Pandemic influenza vaccine H5N1 AstraZeneca 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