Fluarix® suspension for injection in a pre-filled syringe

Influenza vaccine (split virion, inactivated)

Influenza virus (inactivated, split) of the following strains*:

per 0.5 ml dose

This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2012/2013 season.

For a full list of excipients see section 6.1.

Fluarix may contain traces of eggs (e.g. ovalbumin and chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate which are used during the manufacturing process (see section 4.3).

Suspension for injection in a pre-filled syringe.

Fluarix is colourless to slightly opalescent.

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

Fluarix is indicated in adults and children from 6 months of age.

The use of Fluarix 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 ml may be given. The dose given should be in accordance with the existing national recommendations.

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.

Children less than 6 months: the safety and efficacy of Fluarix 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.

Precautions to be taken before handling or administering 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 and chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate.

Immunisation should 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.

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Interference with serological testing

See section 4.5.

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.

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 inactivated influenza vaccines do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.

Breastfeeding

Fluarix may be used during breastfeeding.

Fertility

No fertility data are available.

Fluarix 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 and at least 50 elderly aged 61years 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)

Tabulated list of adverse reactions.

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

Paediatric population

In three clinical studies healthy children 6 months to 17 years of age were administered Fluarix (more than 3500 children).The following adverse reactions have also been reported in this age population.

¹reported in children aged from 6 months to 17 years

²reported in children aged from 6 months to <6 years

³reported in children aged from 6 years to 17 years

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 (symptoms including conjunctivitis), 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 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, α-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 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 (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.

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

Shake before use. Inspect visually prior to administration.

When a dose of 0.5 ml is indicated, the entire contents of the syringe should be injected.

Instructions for administration of 0.25ml of the vaccine for use in children from 6 months to 35 months

When a dose of 0.25 ml is indicated, the pre-filled syringe should be held in upright position and half of the volume should be eliminated until the stopper reaches the marking line printed on the syringe. For syringes without marking line picture 1 is designed to facilitate the use of a 0.25 ml dosage. Align the syringe with the picture so that the upper edge of the syringe corresponds to the upper arrow. Push the plunger until you reach the lower arrow. The remaining volume of 0.25 ml should be injected.

Picture 1

Instructions for administration of the vaccine presented in pre-filled syringe without a fixed needle

1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.

2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. (see picture)

3. Remove the needle protector, which on occasion can be a little stiff.

4. Administer the vaccine.

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

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 authorisation: 27 February 1998

Date of latest renewal: 02 November 2007

8 May 2013