Inactivated Influenza Vaccine (Split Virion) BP, suspension for injection in prefilled syringe.

Influenza vaccine (split virion, inactivated).

Split influenza virus*, inactivated containing antigens equivalent to the following strains:

• A/Brisbane/59/2007 (H1N1) - like strain (A/Brisbane/59/2007 (IVR-148))

................................................................................................................. 15 micrograms HA**

• A/Brisbane/10/2007 (H3N2) - like strain (A/Uruguay/716/2007 (NYMC X-175C))

................................................................................................................. 15 micrograms HA**

• B/Brisbane/60/2008- like strain (B/Brisbane/60/2008)

................................................................................................................. 15 micrograms HA**

* propagated in fertilised hens' eggs from healthy chicken flocks

** haemagglutinin

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

For a full list of excipients, see section 6.1.

Suspension for injection in prefilled syringe.

The vaccine, after shaking gently, is a slightly whitish and opalescent liquid.

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

The use of Inactivated Influenza Vaccine (Split Virion) BP should be based on official recommendations.

Adults and children from 36 months: 0.5 ml.

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.

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

For instructions for preparation, see section 6.6.

Hypersensitivity to the active substances, to any of the excipients, to eggs, chicken proteins, neomycin, formaldehyde and octoxinol 9.

Inactivated Influenza Vaccine (Split Virion) BP does not contain more than 0.05 microgram ovalbumin per dose.

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.

Inactivated Influenza Vaccine (Split Virion) BP should under no circumstances be administered intravascularly.

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

Inactivated Influenza Vaccine (Split Virion) BP 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.

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. 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 influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Inactivated Influenza Vaccine (Split Virion) BP may be used during lactation.

The vaccine is unlikely to produce an effect 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); rare (1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

* These reactions usually disappear within 1-2 days without treatment.

ADVERSE REACTIONS REPORTED FROM POSTMARKETING SURVEILLANCE:

Adverse reactions reported from postmarketing 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:

Generalized skin reactions including pruritus, urticaria or nonspecific 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 postvaccinal immunity to homologuous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Not applicable.

Not applicable.

Buffer solution:

• Sodium chloride

• Potassium chloride

• Disodium phosphate dihydrate

• Potassium dihydrogen phosphate

• 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 – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

0.5 ml of suspension in prefilled syringe (type I glass) with attached needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl) – pack size of 1, 10, 20 or 50.

0.5 ml of suspension in prefilled syringe (type I glass) without needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl)– pack size of 1, 10, 20 or 50.

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

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

Shake before use.

The vaccine should not be used if foreign particles are present in the suspension.

For children, when one dose of 0.25 ml is indicated, push the plunger stopper exactly to the edge of the mark so that the half of the volume is eliminated. The remaining volume should be injected.

Sanofi Pasteur MSD Limited

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire

SL6 1QP

PL 06745/0095

First authorization: 9 December 1968.

Renewal of authorization: 30 December 2002, 27 December 2007

08/2009