Fluarix, suspension for injection in a pre-filled syringe

Influenza vaccine (split virion, inactivated)

Split Influenza virus, inactivated, containing antigens* equivalent to:

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**

per 0.5 ml dose

* propagated in fertilized hens' eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2009/2010 season.

For a full list of excipients see section 6.1.

Suspension for injection in a pre-filled syringe.

Fluarix is colourless to slightly opalescent.

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

The use of Fluarix 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 aged < 9 years, 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 residues, to egg and to chicken protein. Fluarix does not contain more than 0.05 microgram ovalbumin per dose. The vaccine may contain residues of the following substances, e.g. formaldehyde, gentamicin sulphate and sodium deoxycholate.

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.

Fluarix should under no circumstances be administered intravascularly.

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

Fluarix 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 fetal 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.

Fluarix 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 (1/1,000, <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 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

Overdosage is unlikely to have any untoward effect.

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07 BB 02

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.

Sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, RRR-α-tocopheryl hydrogen succinate, polysorbate 80, octoxynol 10 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 at (2°C–8°C).

Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

0.5 ml suspension for injection in prefilled syringe (Type I glass) with a plunger stopper (butyl) with or without needles – pack of 1, 10 or 20.

Not all pack sizes may be marketed

Unused vaccine and other waste material should be disposed of in compliance with local rules for the disposal of products of this nature.

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

When a dose of 0.25 ml is indicated, the prefilled syringe should be held in upright position and half of the volume should be eliminated. The remaining volume should be injected.

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK,

Stockley Park West

Uxbridge

Middlesex UB11 1BT

PL 10592/0118

Date of first authorization: 27 February 1998

Renewal of the authorization: 30 December 2002

07/08/2009