PANDEMIC INFLUENZA VACCINE H5N1 BAXTERSuspension for injectionPandemic influenza vaccine (whole virion, Vero cell derived,inactivated)

USED FOR

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in adults of 18 years of age and older. It is used to prevent influenza (flu) in an officially declared pandemic.

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world. The symptoms (signs) of pandemic flu are similar to those of an ?ordinary? flu but are usually more severe.

The vaccine works by helping the body to produce its own protection (antibodies) against the disease.

Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

• if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
• if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine. The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in Section 6 at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, your doctor may recommend to give the vaccine.

Take special care with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

You should tell your doctor before vaccination

• if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such

as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.

• if you have a poor immune response (as for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
• if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
• If you have a bleeding problem or bruise easily.

There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER below 18 years of age. In case of pandemic national recommendations will be followed.

Taking other medicines

• Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines. However, if this cannot be avoided, the other vaccine should be injected into the other limb. You should be aware that the side effects may be intensified.
• If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins. However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding. Your doctor will decide if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.

Driving and using machines

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may affect your ability to drive or use machines.

Adults from the age of 18 years and older will receive two injections of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER. The time period between the first and the second injection must be at least three weeks.

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle (usually in the upper arm).

The vaccine should never be given into a vein.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, although not everybody gets them.

In the clinical studies with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term. The side-effects are generally similar to those related to the influenza vaccine. There were fewer side effects after the second vaccination compared with the first. The most frequently occurring side effect was injection site pain, which was usually mild.

The following side effects have been reported in clinical studies.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Very common:

• pain at the injection site

Common:

• runny nose and sore throat,
• headache, dizziness, vertigo (motion sickness)
• sweating more than usual,
• joint or muscle pain,
• chills, fatigue (feeling tired), malaise (generally feeling unwell), fever,
• tissue hardening, redness, swelling or bruising at the injection site

Uncommon:

• swollen glands,
• insomnia (difficulty sleeping), restlessness,
• impaired perception of touch, pain, heat and cold, sleepiness,
• conjunctivitis (an inflammation of the eye),
• sudden hearing loss,
• reduced blood pressure,
• shortness of breath, cough, congestion of the nose,
• nausea, vomiting, diarrhoea, stomach pain,
• rash, itching,
• irritation at the injection site

Other side effects which have occurred in the days or weeks after vaccination with flu vaccines include:

Uncommon:

• Generalized skin reactions such as itching, hives or rash

Rare:

• Nerve pain (neuralgia)
• Tingling and numbness
• Fits
• Transient low blood platelet count
• Allergic reactions, in rare cases leading to shock (a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death)

Very rare:

• Inflammation of blood vessels (vasculitis) with s transient kidney problems
• Inflammation of the brain and spinal chord (encephalomyelitis)
• Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face

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

Keep out of the reach and sight of children.

Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
Do not freeze.

After first opening the vial is to be used within a maximum of 3 hours.
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 to protect the environment.

What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains

Active substance:

Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*:

AVietnam12032004 H5N1 7.5 micrograms

per 0.5 ml dose

* propagated in Vero cells (continuous cell line of mammalian origin)
** haemagglutinin

The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.

What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of the pack

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid. 1 pack of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains 20 multidose vials of 5 ml suspension for injection for 10 doses.

Marketing Authorisation Holder:

Baxter AG
Industriestrasse 67
A-1221 Vienna
Austria

Manufacturer:

Baxter AG
Uferstrasse 15
A-2304 Orth/Donau
Austria

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

BelgiëBelgiqueBelgien Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BrusselBruxellesBrüssel TélTel 32 2 650 1711 LuxembourgLuxemburg Baxter Belgium SPRL Bd. de la PlainePleinlaan 5 B-1050 BruxellesBrüssel TélTel 32 2 650 1711

. 4 1000 . 359 2 9808482 Magyarország Baxter Hungary Kft Népfürd u. 22. H-1138 Budapest Tel. 361 202 19 80

eská republika Baxter Czech spol.s r.o. Opletalova 55 CZ-110 00 Praha 1 Tel. 420 225774111 Malta Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel. 44 1635 206345

Danmark Baxter AS Gydevang 43 DK-3450 Allerød Tlf 45 48 16 64 00 Nederland Baxter B.V. Kobaltweg 49 NL-3542 CE Utrecht Tel 31 30 2488911

Deutschland Baxter Deutschland GmbH Edisonstraße 4 D-85716 Unterschleißheim Tel 49 89 31701-0 Norge Baxter AS Gjerdrumsvei 11 N-0484 Oslo Tlf 47 22 58 4800

Eesti AS Oriola Kungla 2 EE-76505 Saue Tel. 372 6 515 100 Österreich Baxter Vertriebs GmbH Landstraer Hauptstrae 99 Top 2A A-1031 Wien Tel. 43 1 71120 0

Polska Baxter Polska Sp. z o.o. ul. Kruczkowskiego 8 PL-00-380 Warszawa Tel. 48 22 4883 777 Baxter Hellas ... 34 GR-163 41 . 30-210-99 87 000

España Baxter S.L. Pouet de Camilo, 2 E- 46394 Ribarroja del Turia Valencia Tel 34 96 2722800 Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira, Edifício 10 P-2710-089 Sintra Tel 351 21 925 25 00

France Baxter SAS 6 Avenue Louis Pasteur F-78310 Maurepas Tél 33 1 3461 5050 România FARMACEUTICA REMEDIA S.A. 78 Metalurgiei Blv., 4th district 041836 Bucharest, ROMANIA Tel. 40-21-321 1640

Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL-Blackrock, Dublin Tel 44 1635 206345 Slovenija Baxter d.o.o. elezna cesta 14 1000 Ljubljana Tel. 386 1 420 16 80

Ísland Icepharma hf. Lynghálsi 13 IS-110 Reykjavík Sími 354 540 80-00 Slovenská republika Baxter AG, o. z. Dúbravská cesta 2 SK-841 04 Bratislava Tel 421 2 59418455

Italia Baxter S.p.A. Piazzale dellIndustria, 20 I-00144 Roma Tel 39 06 324911 SuomiFinland Baxter Oy PL 270 Valimotie 15 A FIN-00381 Helsinki PuhTel 358 9 8621111

Baxter Hellas ... 34 GR-163 41 . 30-210-99 87 000 Sverige Baxter Medical AB Torshamnsgatan 35 Box 63 S-164 94 Kista Tel 46 8 6326400

Latvija Baxter AG Latvijas filile Dzelzavas iela 117 LV 1021 RGA Tel. 371 67784784 United Kingdom Baxter Healthcare Ltd Wallingford Road, Compton Newbury Berkshire RG20 7QW - UK Tel 44 1635 206345

Lietuva

UAB TAMRO atstovyb-
S. -ukausko g. 29-1
LT-09129 Vilnius
Tel.: + 370 5 269 16 91

This leaflet was last approvedin{MM/YYYY}.

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ?exceptional circumstances?. This means that for scientific reasons, it has been impossible to get complete information on this medicine. The European Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.

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The following information is intended for medical or health care professionals only:

Prior to administration, the vaccine should be allowed to reach room temperature and the vial should be shaken well.

After first opening, the vial is to be used within a maximum of 3 hours.

Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.

The vaccine should not be administered intravascularly.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.?