CONTENTS

Inactivated influenza vaccine (split virion).

PRESENTATION

Prefilled syringe 0.25 mL x 1's. 0.5 mL x 1's.

DESCRIPTION

Each 0.25- and 0.5-mL dose contains split influenza virus*, inactivated containing antigens equivalent to the following strains: A/Brisbane/59/2007 (H1N1)-like strain (A/Brisbane/59/2007 (IVR-148)), A/Brisbane/10/2007 (H3N2)-like strain (A/Uruguay/716/2007 (NYMC X-175C)) and B/Brisbane/60/2008-like strain (B/Brisbane/60/2008) 7.5 and 15 mcg HA**, respectively.

*Propagated in fertilised hen's eggs from healthy chicken flocks.

**Haemagglutinin.

Vaxigrip also contains the following excipients: Buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride and water for injection.

The vaccine complies with the WHO recommendations (Northern hemisphere) and EU decision for the 2009/2010 season.

INDICATIONS

Prevention of influenza, particularly in subjects with high-risk associated complications.

DOSAGE & ADMINISTRATION

Adults and Children ³36 months: One 0.5-mL dose.

Children 6-35 months: One 0.25-mL dose.

If the child has not been previously vaccinated, a 2nd dose should be given after at least 4 weeks.

Administration: Administer by IM or deep SC route. The vaccine should be brought to room temperature before use. Shake before use.

For children, when 1 dose of 0.25 mL is indicated, push the plunger stopper exactly to the edge of the mark of the syringe to eliminate half of the volume. The remaining volume should be injected.

CONTRAINDICATIONS

Hypersensitivity to influenza vaccine, to any of the excipients of Vaxigrip, to eggs, chicken proteins, neomycin, formaldehyde or octoxinol-9.

In case of illness with a high temperature or acute infection, the vaccination should be postponed until after the patient has recovered.

PRECAUTIONS

As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Poor immune response (immunodeficiency or taking medicines affecting the immune system), the doctor will decide if the patient should receive the vaccine.

Blood test within the days following the flu vaccination; false-positive blood test results have been observed in a few patients who had recently been vaccinated.

As with all vaccines, Vaxigrip may not fully protect all persons who are vaccinated.

Effects on the Ability to Drive or Operate Machinery: Vaxigrip is unlikely to affect the ability to drive vehicles or use machines.

Use in pregnancy & lactation: Limited data about flu vaccination in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the 2nd trimester of pregnancy. For pregnant women with a risk of complications from influenza, administration of the vaccine is recommended, irrespective of the stage of pregnancy.

Vaxigrip may be used during lactation.

SIDE EFFECTS

During clinical trials, the following side effects have been observed. Their frequencies have been estimated as Common (affects 1-10 users in 100): Headache, sweating, muscular pain (myalgia), joint pain (arthralgia); fever, generally feeling unwell (malaise), shivering, fatigue; local reactions: Redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected. These reactions usually disappear within 1-2 days without treatment.

In addition to the common side effects listed previously, the following side effects occurred during post-marketing experience: In rare cases, allergic reactions leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock).

In very rare cases, swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema).

Skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash.

Blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases, temporary kidney problems.

Pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barre syndrome).

Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia), temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy).

INTERACTIONS

Vaxigrip can be given at the same time as other vaccines by using separate limbs. In this case, the side effects may be intensified.

The immunological response may decrease in case of immunosuppressant treatment eg, corticosteroids, cytotoxic drugs or radiotherapy.

STORAGE

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

Shelf-Life: 1 year.