Optaflususpension for injection in pre-filled syringeInfluenza vaccine (surface antigen, inactivated, prepared incell cultures)(2007/2008 season)

Optaflu is a vaccine against flu (influenza). Due to the kind of manufacturing Optaflu is free of chicken/egg protein. For manufacturing the vaccine the influenza virus was killed and prepared in a special way that the vaccine only contains influenza virus surface proteins (influenza virus surface antigens). These proteins stimulate your immune system so that it can develop a protection against flu.

Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu.

You must NOT use Optaflu

• if you are allergic (hypersensitive) to influenza vaccine or any of the other ingredients of Optaflu
• if you have an acute illness associated with fever
• if you have an acute infection.

Take special care with Optaflu

BEFORE receiving the vaccine

• you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, ?Taking other medicines?).
• your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Optaflu as with all vaccines that are injected. WHILE receiving the vaccine
• your doctor or nurse will take care not to inject Optaflu into a blood vessel.

Children and adolescents

• Optaflu is not recommended for use in children below 18 years of age since there is no information available.

Taking other medicines
Special care should be taken if you are receiving Optaflu and any of the following medicines at the same time:

• medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system. Tell your doctor if you are being treated with such medicines. The immune response of your body may be weakened. Therefore the vaccine may work less effectively.
• other vaccines. Optaflu may be given at the same time as other vaccines. In this case the vaccines should be injected into separate limbs. Note that the side effects of the vaccines may be intensified.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
The safety of Optaflu in pregnant and breast-feeding women has not been determined. The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Optaflu may be used during breast feeding.

Therefore your doctor will decide whether you should receive Optaflu if you are pregnant or breast-feeding.

Important information about some of the ingredients of Optaflu

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium-free?. This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ?potassium-free?.

Optaflu is applied to you by your doctor or nurse.
Usual dose for persons of 18 years and older: 0.5 ml of Optaflu suspension.
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle). Optaflu should under no circumstances be injected into a blood vessel.

Like all medicines, Optaflu can cause side effects, although not everybody gets them.

The following undesirable effects have been observed during clinical trials :

Very common in more than 1 in 10 vaccinees Common in more than 1 in 100 vaccinees, but less than 1 in 10 vaccinees Uncommon in more than 1 in 1,000 vaccinees, but less than 1 in 100 vaccinees Rare in more than 1 in 10,000 vaccinees, but less than 1 in 1,000 vaccinees Very rare in less than 1 in 10,000 vaccinees, including isolated reports

Very serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect ? you may need urgent medical attention or hospitalisation: Very rare:

• difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) Rare:
• numbness and tingling sensation
• painful disorders of the nerves, e.g. attacks of extreme pain in the face, throat or ear fits (convulsions) (only observed with egg-derived influenza vaccines)

Also, tell your doctor immediately if you experience any of the following side effects ? you may need medical attention:
Very rare:

• skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the blood vessels
• fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are symptoms of an inflammation of the brain and spinal cord
• weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves

Serious side effects

Tell your doctor immediately if you experience any of the following side effects ? you may need medical attention:
Very Rare:

• bleeding or bruising which are symptoms of a low platelet count in the blood

Mild side effects

Very common:

• flu-like symptoms such as headache, feeling of discomfort, tiredness.
• Pain, reddening. These reactions are usually mild and only last a few days. Pain and headache were common in the elderly.

Common:

• sweating, joint and muscle pain, chills, hardening or swelling at the site of the injection, bruising, fever, shivering
• gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract These reactions are usually mild and only last a few days.

Uncommon:

• generalised skin reactions such as itching, bumps on the skin or non-specific rash

Rare:

• swelling and pain of local lymphnodes
• Fever greater than 39.0 °C

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 Optaflu after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Storage conditions of the unopened product:

• Store in a refrigerator (2 °C to 8 °C).
• Do not freeze.
• Keep the pre-filled syringe in the carton in order to protect from light.

Preparation of the product before use:
Your doctor or nurse will take care that Optaflu should be allowed to reach room temperature before use and is shaken before use.

Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Optaflu contains

The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
A/Solomon Islands/3/2006 (H1N1) like strain
(A/Solomon Islands/3/2006, IVR-145) 15 micrograms HA**

AWisconsin672005 H3N2 like strain AWisconsin672005, NYMC X161B 15 micrograms HA

B/Malaysia/2506/2004 like strain
(B/ Malaysia/2506/2004)

15 micrograms HA** per 0.5 ml dose

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produced in Madin Darby Canine Kidney MDCK cells this is the special cell culture in which the influenza virus is grown haemagglutinin

The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2007/2008 season.

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

What Optaflu looks like and contents of the pack

Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe). Optaflu is a clear to slightly opalescent suspension.
A single syringe contains 0.5 ml of suspension for injection.
Pack sizes of 1, 10 or 20 (2 x 10), each with or without needle are available.

Marketing Authorisation Holder and Manufacturer

Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg

GERMANY

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

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 1611 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 1611

Novartis Vaccines and Diagnostics GmbH Te. 49 6421 39 7799 Magyarország Novartis Hungária Kft. Tel 36 1 457 6500

eská republika Novartis s.r.o. Tel 42 022 5775 111 Malta Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Danmark Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799 Nederland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Deutschland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7798 Norge Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Eesti Novartis Poland Sp.z o.o. Tel. 48 22 550 8888 Österreich Novartis Pharma GmbH 43 1 866 570

Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 24 3111 Polska Novartis Poland Sp.z o.o. Tel. 48 22 550 8888

España Novartis Vaccines and Diagnostics, S. L. Tel 34 93 306 4200 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 35 121 000 8600

France Novartis Vaccines and Diagnostics SAS Tél 33 1 55 49 0030 România Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Ireland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799 Slovenija Novartis s.r.o Tel 42 022 5775 111

Ísland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799 Slovenská republika Novartis s.r.o Tel 42 022 5775 111

Italia Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 24 3111 SuomiFinland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 24 3111 Sverige Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7799

Latvija United Kingdom

Novartis Poland Sp.z o.o. Tel. 48 22 550 8888 Novartis Vaccines and Diagnostics Ltd Tel 44 845 745 1500

Lietuva

Novartis Poland Sp.z o.o.
Tel.: +48 22 550 8888

This leaflet was last approved in XX/YYYY.