Pandemic influenza vaccine H5N1 AstraZeneca

Package leaflet: Information for the user

Influenza pandemic vaccine H5N1 AstraZeneca nasal spray, suspension
Influenza pandemic vaccine (H5N1) (live attenuated, nasal)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while using this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before the vaccine is administered, as it contains important information for you or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse, or pharmacist.
• This vaccine has been prescribed only for you or your child. Do not give it to others.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, nurse, or pharmacist. See section 4.

Contents of this leaflet:

1. What Influenza pandemic vaccine H5N1 AstraZeneca is and what it is used for
2. What you need to know before administration of Influenza pandemic vaccine H5N1 AstraZeneca
3. How to administer Influenza pandemic vaccine H5N1 AstraZeneca
4. Possible side effects
5. How to store Influenza pandemic vaccine H5N1 AstraZeneca
6. Contents of the pack and other information

1. What Influenza pandemic vaccine H5N1 AstraZeneca is and what it is used for

Influenza pandemic vaccine H5N1 AstraZeneca is a vaccine used to prevent influenza during an officially declared pandemic. It is used in children and adolescents from 12 months up to but less than 18 years of age.
Pandemic influenza is a type of influenza that occurs at intervals ranging from less than 10 years to several decades and spreads rapidly worldwide. The symptoms of pandemic influenza are similar to those of seasonal influenza but may be more severe.
How Influenza pandemic vaccine H5N1 AstraZeneca works
Influenza pandemic vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine containing four strains), except that Influenza pandemic vaccine H5N1 AstraZeneca provides protection against only one strain of influenza during an officially declared pandemic.
When the vaccine is administered to a person, the immune system (the body's natural defence system) will produce protection against the influenza virus. No component of the vaccine can cause influenza.
The virus contained in Influenza pandemic vaccine H5N1 AstraZeneca is cultivated in hens' eggs. The influenza strain used in the vaccine during an officially declared pandemic is recommended by the World Health Organization.

2. What you should know before administration of the Pandemic Influenza Vaccine

H5N1 AstraZeneca
The Pandemic Influenza Vaccine H5N1 AstraZeneca must not be administered:

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

If you fall into any of the above categories, consult your doctor, nurse, or pharmacist.
Warnings and precautions
Inform your doctor, nurse, or pharmacist before vaccination:

• if the child is less than 12 months old. Children under 12 months of age should not receive this vaccine due to the risk of adverse reactions.
• if you have previously experienced any allergic reaction, except a sudden life-threatening allergic reaction, to eggs, egg proteins, gentamicin, gelatine, or to any of the other components of this vaccine (listed in section 6 “Contents of the pack and other information”).
• if you are currently taking acetylsalicylic acid (a substance found in many medicines used to reduce pain and lower fever), due to the risk of developing a very rare but serious illness (Reye's syndrome).
• if you have a blood disorder or a tumour that affects the immune system.
• if your doctor has told you that you have a weakened immune system due to illness, medication, or other treatment.
• if you suffer from severe asthma or shortness of breath (dyspnoea).
• if you are in close contact with someone who has a severely weakened immune system (for example, a patient undergoing bone marrow transplantation who needs to remain in isolation).

If you or the child fall into any of the above categories, consult your doctor, nurse, or pharmacist
before vaccination. Your doctor will decide whether the Pandemic Influenza Vaccine H5N1 AstraZeneca
is suitable for you.
Other medicines, other vaccines, and the Pandemic Influenza Vaccine H5N1 AstraZeneca
Inform your doctor, nurse, or pharmacist if the person to be vaccinated is taking,
has recently taken, or might take any other medicines, including medicines not requiring a doctor’s prescription.

• Do not administer acetylsalicylic acid (a substance found in many medicines used to reduce pain and lower fever) to children within 4 weeks after vaccination with the Pandemic Influenza Vaccine H5N1 AstraZeneca, unless otherwise directed by a doctor, nurse, or pharmacist. This is due to the risk of Reye's syndrome, a very rare but serious illness that can affect the brain and liver.
• It is recommended not to administer the Pandemic Influenza Vaccine H5N1 AstraZeneca concomitantly with antiviral medicines specific for influenza, such as oseltamivir and zanamivir, as the vaccine’s effectiveness may be reduced.

Your doctor, nurse, or pharmacist will determine whether the Pandemic Influenza Vaccine
H5N1 AstraZeneca can be administered together with other vaccines.
Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, seek advice from your doctor, pharmacist, or nurse before vaccination. Your doctor will decide whether the Pandemic Influenza Vaccine H5N1 AstraZeneca is suitable for you.
• The use of Pandemic Influenza Vaccine H5N1 AstraZeneca is not recommended in women who are breastfeeding.

Driving and using machines
The Pandemic Influenza Vaccine H5N1 AstraZeneca does not affect, or has a negligible effect on,
the ability to drive vehicles or operate machinery.

3. How the Pandemic Influenza H5N1 AstraZeneca Vaccine is Administered

The Pandemic Influenza H5N1 AstraZeneca Vaccine will be administered under the supervision
of a doctor, nurse, or pharmacist.
The Pandemic Influenza H5N1 AstraZeneca Vaccine must only be used as a nasal spray.
The Pandemic Influenza H5N1 AstraZeneca Vaccine must not be injected.
The Pandemic Influenza H5N1 AstraZeneca Vaccine will be administered as a spray into
both nostrils. You can breathe normally during administration of the Pandemic Influenza H5N1
AstraZeneca Vaccine. It is not necessary to actively inhale or breathe in deeply.
Dosage
The recommended dose for children and adolescents is 0.2 ml of Pandemic Influenza H5N1
AstraZeneca Vaccine, with 0.1 ml administered into each nostril. All children will receive a second
booster dose after an interval of at least 4 weeks.
If you have further questions about this vaccine, please consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone gets them. In clinical studies with the vaccine, most side effects were mild and short-lived.
Consult your doctor, nurse or pharmacist for further information on possible side effects of the Pandemic Influenza Vaccine H5N1 AstraZeneca.
Some side effects can 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.

If you experience any of the above side effects, contact your doctor immediately or go as soon as possible to the emergency department.
In clinical studies conducted in adults who received the Pandemic Influenza Vaccine H5N1 AstraZeneca, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat and paranasal sinuses).
Other possible side effects of the Pandemic Influenza Vaccine H5N1 AstraZeneca in
children and adolescents:
Very common
(may affect more than 1 in 10 people):

• runny or stuffy 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
• nosebleed
• allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the AstraZeneca Pandemic Influenza H5N1 Vaccine

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the label of the applicator after
Exp.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the nasal applicator in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What the Pandemic Influenza Vaccine H5N1 AstraZeneca contains
The active substance is:
Recombinant influenza virus* (live attenuated) of the following strain**:
strain A/Vietnam/1203/2004 (H5N1)
(A/Vietnam/1203/2004, MEDI 0141000136) 10 FU***
.......................................................................................................per 0.2 ml dose
* propagated in fertilized chicken eggs from healthy flocks.
** produced in VERO cells using reverse genetics. The product contains genetically modified organisms (GMOs).
*** fluorescent units
The vaccine complies with WHO recommendations and EU decision for pandemic.
Other components are: sucrose, potassium phosphate dibasic, potassium dihydrogen phosphate, gelatin (porcine, type A), arginine hydrochloride, monosodium glutamate monohydrate, and water for injections.

Description of the appearance of Pandemic Influenza Vaccine H5N1 AstraZeneca and contents of the pack
This vaccine is a nasal suspension in a spray contained in a single-use nasal applicator (0.2 ml) in a pack of 10.
The suspension is colourless or pale yellow, from clear to slightly cloudy. Small white particles may be present.

Marketing Authorisation Holder
AstraZeneca AB,
SE-151 85
Södertälje,
Sweden

Manufacturer
AstraZeneca Nijmegen B.V.,
Lagelandseweg 78
Nijmegen, 6545CG
The Netherlands

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

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2-10 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) Ltd AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρμακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

This medicine has been granted a marketing authorisation under "conditional approval". This means that additional data on this medicine are required.
The European Medicines Agency will review new information annually and this package leaflet will be updated as necessary.

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for healthcare professionals
The following information is intended exclusively for healthcare professionals:
The 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 after the expiry date or if the atomizer appears damaged, for example, if the plunger is loose or removed from the atomizer or if there are any signs of leakage.
• Check the appearance of the vaccine before administration. The suspension should be colourless to light yellow, clear to opalescent. Small white particles may be present.
• Pandemic Influenza Vaccine H5N1 AstraZeneca is administered as a divided dose into both nostrils as described below (see also section 3 How is Pandemic Influenza Vaccine H5N1 AstraZeneca administered).
• After administering half of the dose into one nostril, administer the other half of the dose into the other nostril immediately or shortly afterwards.
• The patient may breathe normally during vaccine administration; active inhalation is not required.

Check the expiry date Prepare the applicator Position the applicator
Remove the rubber cap from the tip. With the patient in an upright position, insert the tip just into the nostril to ensure delivery of the Pandemic Influenza Vaccine H5N1 AstraZeneca into the nose. Do not remove the dose-divider clip at the other end of the applicator.

Press the plunger Remove the dose-divider clip Spray into the other nostril
In a single motion, press the plunger as quickly as possible until the dose-divider clip prevents further movement. For administration into the other nostril, insert the tip just into the other nostril and, in a single motion, press the plunger as quickly as possible to deliver the remaining vaccine.
For advice on storage and disposal, see section 5.