Hepatitis B vaccine

HEPATITIS В VACCINE (recombinant)

Description Recombinant hepatitis В vaccine (Combiotech vaccine) is a subunit viral vaccine consisting of surface antigen (HBsAg) of hepatitis В (ayw subtype), produced from recombinant yeast strain Saccharomyces cerevisiae according to methods developed in Science industry company "Combiotech Ltd", Moscow, Russia. The vaccine against hepatitis B, prepared from recombinant yeast strains, is free from human blood and blood products. One dose of adult formulation vaccine (1 ml) contains 20 meg of HBsAg adsorbed onto 0,5 mg of aluminium hydroxide; one dose of pediatric formulation vaccine (0,5 ml) contains 10 meg of HBsAg adsorbed onto 0,25 mg of aluminium hydroxide. All formulations contain 0,005 % thimerosal added as preservative. Each lot of hepatitis В vaccine is tested for immunogenicity in mice, for safety in mice and guinea pigs, and for sterility.

Indications The vaccine is of the ayw subtype. This vaccine is indicated for persons at risk of infection from hepatitis В virus including all known subtypes. Vaccination with hepatitis В vaccine ("Combiotech Ltd") is recommended in person of all ages who are or will be at increased risk of infection with hepatitis В virus and hepatitis D virus. Health care personnel: oral surgeons; nurses; paramedical personnel; staff in haemodialysis, haematology, oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; emergency and first aid workers; ambulance staff.

Dosage and administration. Do not inject intravenously or intradermally. Combiotech® vaccine should be administered intramusculary. The deltoid muscle is the preferred site for intramuscular injection in adults. The anterolateral thigh is the recommended site for intramuscular injection in neonates and infants. Exceptionally, the vaccine may be administered subcutaneously in patients with severe bleeding tendencies (e.g. halmophiliacs).

Vaccination schedule. Primary vaccination consists of three intramuscular doses of vaccine:

1 st injection: at elected day

2nd injection: > 1 month later

3rd injection: > 6 month from the date of the first dose.

Contraindications Hypersensitivity to any component of the vaccine. As for any vaccine, Hepatitis В vaccine schould not be administered to subject with severe febrile infections.

Precautions The effect of the antigen in foetal development in unknown and there fore general vaccination of pregnant women can not be recommended. Vaccination of a pregnant women may be considered in high risk situations. As with all biological , a solution of 1 in 1,000 adrenaline schould always be reaclih available for immediate use in case of a rare anaphylactic reaction.

Side effects Combiotech vaccine is generally well-tolerated. No serious side effects attributable to vaccination were reported during the course of wide clinical trials involving the administration of vaccine to over 1100 individuals. The most commonly reported local reactions are soreness, erythema and swelling at the injection site as seen with all adsorbed vaccines. These reaction are mild and usually subside within two days after vaccination. Uncommon systemic complaints such a fever, headache, nausea, dizzness have no been observed.

Recommended storage and shipment condition: The vaccine should be shipped under refrigeration and stored at + 2 °C to 8° С.