Havrix® Junior Monodose® vaccine

Hepatitis A virus antigen, 720 ELISA units/0.5 ml dose.

For excipients, see Section 6.1.

Vaccine for injection

Havrix Junior Monodose vaccine is indicated for active immunisation against HAV infection. The vaccine is particularly indicated for those at increased risk of infection or transmission. It is also indicated for use during outbreaks of hepatitis A infection.

Havrix Junior Monodose vaccine should be injected intramuscularly in the deltoid region. The vaccine should never be administered intravenously.

Dosage

Children/adolescents (1-15 years)

Primary immunisation consists of a single dose of Havrix Junior Monodose vaccine (720 ELISA units/0.5 ml) given intramuscularly. This provides anti-HAV antibodies for at least one year.

Havrix Junior Monodose confers protection against hepatitis A within two to four weeks.

In order to obtain more persistent immunity, for at least 10 years, a booster dose is recommended between 6 and 12 months after primary immunisation.

Booster vaccination with Havrix Junior Monodose delayed up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval.

Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2 dose vaccination course.

Havrix Junior Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine.

In the event of a subject being exposed to a high risk of contracting hepatitis A within two weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with Havrix Junior Monodose at different injection sites.

Hypersensitivity to any component of the vaccine.

Severe febrile illness.

As with all vaccinations, appropriate medication e.g.epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis. Havrix Junior Monodose may contain traces of the antibiotic neomycin B sulphate.

It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether Havrix Junior Monodose will prevent hepatitis A in such cases.

In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after the primary immunisation and such patients may therefore require administration of additional doses of vaccine.

Simultaneous administration of Havrix with normal immunoglobulin does not influence the seroconversion rate to Havrix, however, it may result in a lower antibody titre. A similar effect could be observed with Havrix Junior Monodose.

Preliminary data on the concomitant administration of Havrix, at a dose of 720 ELISA units/ml, with recombinant hepatitis B virus vaccine suggests that there is no interference in the immune response to either antigen. On this basis and since it is an inactivated vaccine interference with immune response is unlikely to occur when Havrix Junior Monodose is administered with other inactivated or live vaccines. When concomitant administration is considered necessary the vaccines must be given at different injection sites.

Havrix Junior Monodose must not be mixed with other vaccines in the same syringe.

The effect of Havrix Junior Monodose on foetal development has not been assessed. However, as with all inactivated viral vaccines the risks to the foetus are considered to be negligible. Havrix Junior Monodose should be used during pregnancy only when clearly needed.

The effect on breast-fed infants of the administration of Havrix Junior Monodose to their mothers has not been evaluated in clinical studies. Havrix Junior Monodose should therefore be used with caution in breast-feeding women.

Not applicable.

These are usually mild and confined to the first few days after vaccination. The most common reactions are mild transient soreness, erythema and induration at the injection site. Less common general complaints, not necessarily related to the vaccination, include headache, fever, malaise, fatigue, nausea, vomiting, diarrhoea and loss of appetite and rash. Arthralgia, myalgia, convulsions and allergic reactions including anaphylactoid reactions have been reported very rarely. Elevations of serum liver enzymes (usually transient) have been reported occasionally. However, a causal relationship with the vaccine has not been established.

Neurological manifestations occurring in temporal association have been reported extremely rarely with the vaccine and include transverse myelitis, Guillain-Barré syndrome and neuralgic amyotrophy. No causal relationship has been established.

Not applicable.

Havrix confers immunisation against HAV by stimulating specific immune responses evidenced by the induction of antibodies against HAV.

In clinical studies involving subjects of 1 – 18 years of age, specific humoral antibodies against HAV were detected in 93% of vaccines at day 15 and 99% of vaccines one month following administration of Havrix Junior Monodose.

The efficacy of Havrix was evaluated in different community outbreaks. These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks. In one study, vaccine coverage in excess of 80% was followed by termination of the outbreak within 4 to 8 weeks.

Long term persistence of hepatitis A antibody titres following 2 doses of Havrix given 6 to 12 months apart has been evaluated in adults. Data available after 10 years allows prediction that at least 97% of subjects will remain seropositive (>20 mIU/ml) 25 years after vaccination.

Not applicable.

Not applicable to vaccine products.

Aluminium hydroxide gel (3% w/w)

Polysorbate 20

Amino acids for injection

Disodium phosphate

Monopotassium phosphate

Sodium chloride

Potassium Chloride

Water for injections

Not applicable.

Havrix Junior Monodose vaccine has a shelf-life of three years from the date of manufacture when stored at 2-8°C.

Store at 2 - 8°C in a refrigerator. Keep in outer container. Do not freeze.

Neutral glass vials (type 1, PhEur) with grey butyl rubber stoppers and aluminium overcaps fitted with flip-off tops.

0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles - pack size of 1 or 10.

Not all pack sizes may be marketed.

The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. Before use, the vaccine should be well shaken to obtain a slightly opaque white suspension. Discard the vaccine if the content appears otherwise.

SmithKline Beecham plc

980 Great West Road, Brentford, Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

PL 10592/0080.

14 March 2003

1 April 2009

POM