Abbott Healthcare Products Limited

Influvac Sub-unit 2011/2012, suspension for injection (influenza vaccine, surface antigen, inactivated).

Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:

* propagated in fertilised hens' eggs from healthy chicken flocks

** haemagglutinin.

This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2011/2012 season.

For a full list of excipients see section 6.1.

Influvac 2011/2012 may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin, which are used during the manufacturing process (see section 4.3).

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

Prophylaxis of influenza, especially those who run an increased risk of associated complications.

Influvac 2011/2012 is indicated in adults and children from 6 months of age.

The use of Influvac Sub-unit 2011/2012 should be based on official recommendations.

Posology

Adults: 0.5 ml.

Paediatric population

Children from 36 months onwards: 0.5 ml.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 mlmay be given. The dose given should be in accordance with existing national recommendations.

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

Children less than 6 months: the safety and efficacy of Influvac 2011/2012 in children less than 6 months have not been established. No data are available.

Method of Administration

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

Precaution to be taken before handling or administrating the medicinal product:

For instructions for preparation of the medicinal product before administration, see section 6.6.

Hypersensitivity to the active substances, to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), 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 should under no circumstances be administered intravascularly.

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

Interference with serological testing: see section 4.5.

Influvac Sub-unit 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.

Pregnancy

Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.

Breastfeeding

Influvac Sub-unit may be used during breastfeeding.

Fertility

No fertility data is available

Influvac Sub-unit has no or negligible influence on the ability to drive and use machines.

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)

Tabulated list of adverse reactions:

* 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, febrile 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

Overdosage is unlikely to have any untoward effect.

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02.

Seroprotection is generally obtained within 2 to 3 weeks. The duration of post-vaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Not applicable.

Not applicable.

Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

1 year.

Store in a refrigerator (+2°C to +8°C).

Do not freeze.

Protect from light.

0.5 ml suspension for injection in prefilled syringe with / without needle (glass, type I), pack of 1 or 10.

The vaccine should be allowed to reach room temperature before use.

Shake before use. Inspect visually prior to administration.

For the administration of a 0.25 ml dose from a single dose 0.5ml syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a volume of 0.25 ml of the vaccine remains in the syringe, suitable for administration. See also section 4.2.

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

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

PA 108/17/4

February 1998 / December 2007

May2012