DESCRIPTIVE NAME OF MEDICINE: Inactivated Hepatitis A virus vaccine.
PHARMACOLOGICAL CLASSIFICATION: A.30.1. Antigens
HAVRIX, hepatitis A virus vaccine is a sterile suspension containing formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed onto aluminium hydroxide.
The virus is adsorbed on 0.5 mg of aluminium in the form of aluminium hydroxide. The vaccine preparation also contains 0.5% (m/v) of 2-phenoxyethanol as a preservative. Other excipients are (per dose): polysorbate 20 (0.05 mg), amino acid supplement (0.3% w/v) in a phosphate buffered saline solution.
IDENTIFICATION: The virus is propagated in MRC5 human diploid cells. Before viral extraction the cells are extensively washed to remove culture medium constituents. A virus suspension is then obtained by lysis of the cells followed by purification using ultrafiltration techniques and gel chromatography. Inactivation of the virus is assured by treatment with formalin. HAVRIX contains a sterile suspension of virus; the viral antigen content is determined by an ELISA test. Each dose is standardised to ensure a viral antigen content of not less than 720 ELISA Units of viral antigens, in a 1.0-mL dose volume.
PHARMACOLOGICAL ACTION OF THE MEDICINE::
HAVRIX confers immunity against Hepatitis A virus (HAV) infection by inducing the production of specific anti-HAV antibodies.
HAVRIX is indicated for active immunisation against HAV infection in subjects at risk of exposure to HAV.
- In areas of low and intermediate prevalence of Hepatitis A, immunisation with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as:
Travellers. Persons moving from areas of low endemicity to areas of high endemicity should be immunised.
Persons for whom Hepatitis A is an Occupational Hazard or for who there is an Increased Risk of Transmission.
Contacts of Infected Persons.
HAVRIX should not be administered to subjects with known hypersensitivity to any components of the vaccine, or to subjects having shown signs of hypersensivity after previous HAVRIX administration. As with other vaccines, the administration of HAVRIX should be postponed in subjects with severe febrile illness. The presence of a minor infection however, is not a contraindication.
WARNINGS: 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 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 course and such patents may therefore require administration of additional doses of vaccine.
It is not known whether HAVRIX will prevent Hepatitis A in such cases and it is advised that antibody titres be done in these cases to monitor the effectiveness.
Clinical experience with HAVRIX in children is limited. For children likely to be at risk of exposure to HAV the vaccine should be used with caution.
DOSAGE AND DIRECTIONS FOR USE: Each dose consists of a 1,0 mL sterile suspension. The vaccine must be used as supplied. The recommended dose of the vaccine must be administered. For Persons travelling to an endemic area, the recommended standard primary course should be competed before entering the endemic area.
The standard primary course of vaccination with HAVRIX consists of two doses, the first administered at the elected date and the second one month later. If necessary, the second dose may be administered a minimum of two weeks following the first dose.
A booster is recommended at any time between 6 and 12 months after the initiation of the primary course in order to ensure long term antibody titres.
In the event a subject is expected to be exposed to a high risk of contracting hepatitis A before the completion of the primary immunisation scheme, concomitant administration of HAVRIX and ISG might be considered.
HAVRIX should be injected INTRAMUSCULARLY in the DELTOID region. The vaccine should not be administered intramuscularly in the gluteal region or subcutaneously/intradermally since administration by these routes in a less than optimal anti-HAV antibody response.
Parenteral drug and vaccine products should be inspected visually for any particulate matter or discoloration prior to administration. Before use of HAVRIX, the vial/syringe should be well shaken to obtain a slightly opaque white suspension. Discard if the contents of the vial/syringe appear otherwise.
The vaccine should never be administered intravenously.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The local solicited adverse events the most frequently reported were injection site soreness, induration, redness and swelling. Systemic adverse events reported include headache, malaise, fatigue, fever, nausea, and loss of appetite.
Appropriate medication (e.g. adrenaline) should be readily available for immediate use in case of anaphylaxis or anaphylactoid reactions following the administration of the vaccine.
HAVRIX should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Pregnancy and Lactation: The effect of HAVRIX on fetal development has not been assessed. HAVRIX should be used during pregnancy and lactation only when clearly needed.
Interactions: The concomitant administration of HAVRIX and ISG does not influence the seroconversion rate, but may result in a relatively lower anti-HAV antibody titre than when the vaccine is given alone. HAVRIX and ISG should be administered at separate injection sites.
When concomitant administration of other vaccines is considered necessary, the vaccines must be given with different syringes and at different injection sites.
Early clinical experiences on the concomitant administration of HAVRIX and the recombinant hepatitis B virus vaccine have been satisfactory. No interference in the respective immune responses to both antigens has been observed.
HAVRIX must not be mixed with other vaccines.
PRESENTATION: Pack of one monodose vial.
HAVRIX must be stored at +2°C to +8°C.
DO NOT FREEZE; discard if vaccine has been frozen.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT SmithKline Beecham Pharmaceuticals (Pty) Ltd
6 Carey Street
Wynberg Ext. 6