Havrix® Junior Monodose® vaccine

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

For a full list of 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.

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.

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.

The safety profile presented below is based on data from more than 5300 subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance. It should be noted that it was not possible to calculate the frequency of reactions from the post-marketing data, therefore the frequency is noted as “Not known”.

The most frequently reported reactions are pain and redness at site of injection (Havrix Monodose has reports in over 50% of doses, Havrix Junior Monodose has reports in 18.2% of doses overall). Swelling at the site of injection was the next most frequently reported reactions.

Frequencies per dose are defined as follows:

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness

* refers to adverse reaction reported only for Havrix Monodose (1ml adult dose)

** refers to adverse reactions reported only for Havrix Junior Monodose (0.5ml children's dose)

# this adverse reaction was identified through post-marketing surveillance but was not observed in randomised controlled clinical trials. The frequency category of rare was estimated from a statistical calculation based on the total number of paediatric patients exposed to Havrix in randomised controlled clinical trials (n=4574).

Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.

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.

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 10592/0080.

14 March 2003

16 April 2012

POM