Havrix Hepatitis A vaccine (HM 175 strain)

Presentation

‘Havrix’ is a formaldehyde-inactivated vaccine prepared from hepatitis A virus (HAV) HM 175 strain grown in human diploid cells. It is provided in prefilled syringes containing a turbid, white suspension. Each 1 ml dose contains not less than 720 ELISA units of hepatitis A viral protein adsorbed on aluminium hydroxide adjuvant together with 0.5% w/v 2-phenoxyethanol as preservative.

Uses

Active immunisation against infections caused by hepatitis A virus. The vaccine is particularly indicated for those at increased risk of infection. This includes those travelling to, or living in, medium or high endemicity areas (see Further information). Other high risk groups include recent close contacts of infected individuals and potential contacts of cases such as childcare or healthcare workers. In the event of case contact, human normal immunoglobulin should be given simultaneously with ‘Havrix’ at different sites.

Individuals who could potentially play a key role in transmitting infection, e.g. food-handlers, might also be considered for vaccination.

Dosage and administration

‘Havrix’ is for intramuscular use only and must not be given intravenously, subcutaneously or intradermally.

Before using ‘Havrix’, the syringe should be well shaken to obtain a slightly opaque white suspension. Discard if the contents of the syringe appear otherwise.

The immunisation regimen consists of two doses of 1 ml of vaccine spaced two weeks to one month apart and provides anti-HAV antibodies for at least one year. In order to obtain more persistent immunity of up to 10 years, a 1 ml booster dose is recommended between six and 12 months following the initial dose.

Adults: 720 ELISA units (1 ml) given intramuscularly. The syringe should be shaken well before use and the vaccine administered into the deltoid region and not in the gluteal region. In patients with severe bleeding tendencies such as haemophiliacs, subcutaneous injection may be considered.

Children/adolescents less than 16 years: No paediatric dose is yet established.

Contra-indications, warnings, etc.

Contra-indications: Hypersensitivity to any component of the vaccine.   Severe febrile infections.

Precautions: As with all vaccinations, appropriate medication (e.g. adrenaline) should be readily available for immediate use in case of anaphylaxis following injection.

Because of the incubation period of hepatitis A, infection may be present at the time of vaccination. If so, ‘Havrix’ may be ineffective.

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

Interactions: ‘Havrix’ may be administered simultaneously with human normal immunoglobulin although they should be administered at separate injection sites. Although simultaneous administration does not influence the seroconversion rate to ‘Havrix’, it may result in a lower antibody titre.

Preliminary data on the concomitant administration of ‘Havrix’ with recombinant hepatitis B virus vaccine suggests that there is no interference in the immune response to either antigen. Interference with immune response is unlikely to occur when ‘Havrix’ is administered with

other inactivated or live vaccines. When concomitant administration is considered necessary, the vaccines must be given at different injection sites.

‘Havrix’ must not be mixed with other vaccines in the same syringe.

Use in pregnancy and lactation: The effect of ‘Havrix’ 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’ is not recommended in pregnancy unless there is a definite risk of hepatitis A.

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

Adverse reactions: 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 vaccination, include fever, malaise, fatigue, headache, nausea and loss of appetite. Elevations of serum liver enzymes have been reported. However, a causal relationship with the vaccine has not been established.

Pharmaceutical precautions

‘Havrix’ should be stored between 2C and 8C and must not be frozen. The shelf-life is two years. It should not he diluted. Protect from light.

Legal categoryPOM.

Package quantities

Prefilled syringes containing 1 ml suspension in packs of one and 10.

Further information

The following examples of subjects at increased risk of infection should be considered for vaccination: travellers to areas of medium to high endemicity (all countries outside Northern Europe, North America, Australia and New Zealand; this group includes business and holiday travellers, Armed Forces and airline personnel, and immigrants visiting country of origin); workers in child-care centres, institutions and healthcare personnel; sanitation workers; male homosexuals; drug abusers.

In order to prevent spread of infection, food handlers, e.q. kitchen workers and food packagers, should also be considered for vaccination.

Inactive ingredients are aluminium hydroxide, 2-phenoxyethanol, polysorbate 20, amino acid supplement, disodium phosphate, monopotassium phosphate, sodium chloride, potassium chloride, water for injections, and also a trace of neomycin B sulphate (maximum 20 ng, 0.Ol4iu).

Marketing Authorisation held by SmithKline Beecham plc, Brentford, England

Manufactured by SmithKline Beecham Biologicals SA, Rixensart, Belgium

SmithKline Beecham Pharmaceuticals

Welwyn Garden City, Hertfordshire AL7 1 EY

Telephone: Welwyn Garden (0707) 325111

‘Havrix’ is a trade mark

1992 SmithKline Beecham Pharmaceuticals

Date of preparation: February 1992

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