Foclivia suspension for injection in pre-filled syringePandemic influenza vaccine (surface antigen, inactivated,adjuvanted)

Foclivia is a vaccine against a pandemic influenza (flu).
It has to be used for the prophylaxis of influenza in an officially declared pandemic situation. The vaccine works by causing the body to produce its own protection (antibodies) against the disease

Do not take Foclivia if you:

• have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia,
• are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia,
• are allergic to eggs, chicken protein,
• are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.

Take special care with Foclivia if you:

• feel feverish,
• have any illness or infection,
• are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions), In any of these cases, TELL YOUR DOCTOR, as vaccination may not be recommended, or may need to be delayed.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Foclivia should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb. In such cases, the side effects may be more intense).

Pregnancy and breast-feeding

In a severe pandemic situation, the administration of the vaccine is recommended in pregnant women, irrespective of their stage of pregnancy. The vaccine may be used during lactation.

Driving and using machines
The vaccine is unlikely to produce any effect on the ability to drive and use machines.

Your doctor or nurse administers the vaccine.
A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle). A second dose of vaccine should be given after an interval of at least 3 weeks.

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

Common (in more than 1 out of 100 people, but less than 1 in 10).
Common side effects include: redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site. In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints. These reactions usually disappear within 1-2 days without treatment. If they persist, CONSULT YOUR DOCTOR.

Uncommon: (in more than 1 out of 1,000 people, but less than 1 in 100).
Uncommon side effects may include: generalised skin reactions including itching, bumps on the skin or a non-specific rash.

Rare (in more than 1 out of 10,000 people, but less than 1 in 1,000). Rare side effects include: numbness or tingling sensations, involuntary muscle contractions or transient thrombocytopenia (a low platelet count in the blood which can result in bleeding or bruising).
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

Very rare (in less than 1 in 10,000). Very rare side effects include: vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme). Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.

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

Keep out of the reach and sight of children.

Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.

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

What Foclivia contains

• Active Substance: Foclivia does not contain live virus particles and so it cannot cause Pandemic influenza. The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). They are isolated from the surface of influenza virus particles, which are grown in hen?s eggs and inactivated with formaldehyde. These viral proteins are prepared from the strain of influenza virus that complies with the WHO recommendations and EU decision in an officially declared Pandemic situation. One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:

A/Vietnam/1194/2004 (H5N1)

• Adjuvant: The vaccine contains an ?adjuvant? (a compound containing squalene) to stimulate a better response. The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer.
• Other Ingredients: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.

What Foclivia looks like and contents of the pack

Foclivia is a milky-white liquid.
It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 ? Siena, Italy.

Manufacturer
Novartis Vaccines and Diagnostics S.r.l. - Loc. Bellaria - 53018 Rosia ? Sovicille (SI), Italy

This leaflet was last approved in {MM/YYYY}.

Foclivia has been authorised under ?Exceptional Circumstances?.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.