Influvac sub-unit 2008/2009, suspension for injection (influenza vaccine, surface antigen, inactivated).

Suspension for injection in prefilled syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I).

Prophylaxis of influenza, especially in those who run an increased risk of associated complications. The use of Influvac sub-unit 2008/2009 should be based on official recommendations.

Adults and children from 36 months: 0.5 ml.

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken protein (Influvac sub-unit 2008/2009 does not contain more than 1 µg ovalbumin per dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.

Immunisation shall be postponed in patients with febrile illness or acute infection.

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

Influvac sub-unit 2008/2009 should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

Influvac sub-unit 2008/2009 may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false-positive reactions could be due to the IgM response by the vaccine

ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALS

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 - 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies:

very common (>1/10); common (1/100, <1/10); uncommon (1/1000, <1/100); rare (1/10000, <1/1000); very rare (<1/10000), including isolated reports.

* these reactions usually disappear within 1-2 days without treatment

ADVERSE REACTIONS REPORTED FROM POST-MARKETING SURVEILLANCE

Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders:

Neuralgia, paraesthesia, febril convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome

Vascular disorders:

Vasculitis associated in very rare cases with transient renal involvement

Skin and subcutaneous tissue disorders:

Generalised skin reactions including pruritus, urticaria or non-specific rash

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