Recombinant HEPATITIS B Vaccine
Hepatitis B vaccine recombinant contains a non infectious hepatitis B viral antigen, HBsAg, which is produced in yeast cell using recombinant DNA technology. Hepatitis B vaccine is a whitish sterile suspension in prefill injection device, packed in aluminum foil pouch, and vial.
- Each 1.0 mL dose contains 20 mcg of HBsAg adsorbed onto 0.5 mg of Al3+
- Each 0.5 mL dose contains 10 mcg HBsAg adsorbed onto 0.25 mg of Al3+
- Thimerosal 0.01 w/v% is used as preservative.
Hepatitis B Vaccine recombinant is indicated for active immunization against infection caused by hepatitis B virus. The vaccine will not protect against infection caused by other agents, such as hepatitis A virus, hepatitis C virus or other viruses known to infect the liver. The vaccine can be administered at any age from birth onwards. Vaccination is recommended in persons who are or will be at risk of infection with hepatitis B virus. These include :
- Health care professionals
Oral surgeons, dentists, physicians and surgeons, dental nurses, dental hygienist, paramedical professionals in close contact with patients, staff in haemodialysis, haematology and oncology units, laboratory personnel handling blood and other clinical specimens, morticians and embalmers, blood bank and plasma fractionation workers, chiropodist, cleaning staff in hospitals handling waste, emergency and first aid workers, ambulance staff.
Patients receiving frequent blood transfusions or clotting factor concen- trates such as patients in haemodialysis and oncology units, thalassaemics, sickle-cell anaemics, cirrhotics and haemophiliacs, etc.
- Personnel and residents of institu- tions
Persons who frequent and/or close contact with high risk groups; prisoners and prison staff; residents and staff of institutions for the mentally handicapped.
- Persons at increased risk due to their sexual activities
Sexually promiscuous persons, persons who repeatedly contact sexually transmitted disease, homosexually active males, prostitutes.
- Illicit users of addictive injectable drugs
- Travellers to high endemic areas and their close contact
- Family member contacts of any of the above groups and of patients with acute or chronic Hepatitis B infection
- Infants born from Hepatitis B carrier mothers.
Hepatitis B vaccine recombinant should be injected intramuscularly, in adults the injection should be given in the deltoid muscle, and in the anterolateral thigh in neonates and infants. Exceptionally the vaccine may be administered subcutaneously in patients with severe bleeding tendencies (e.g. haemophilia).
- The most commonly reported local reactions are soreness, erythema and swelling at the injection site. These reactions are mild and usually subside within 2 days after vaccination.
- Uncommon systemic complaints such as fever, headache, nausea, dizziness and fatigue have been observed in some vaccinees but the causal relationship with the vaccine has not been established.
- Hypersensitivity to any component of the vaccine.
- As for any vaccine, Hepatitis B vaccine recombinant should not be administered to persons with severe febrile infections.
- The presence of a trivial infection does not contraindicate vaccination.
WARNING & PRECAUTION
- The effect of antigen on foetal development is unknown and therefore general vaccination of pregnant women cannot be recommended. However, vaccination of pregnant women may be considered in order to prevent Hepatitis B in high-risk situation.
- Hepatitis B vaccine recombinant should not be administered in the gluteal region or intradermally since this routes of administration may not result in an optimum immune response and may cause damage of gluteal or intradermal nerves.
- The vaccine should not be administered intravenously.
- In dialysis patients and subjects who have an impairment of the immune system, may require repeated administration of the vaccine.
- Hepatitis B recombinant vaccine could be stored until 26 months after manufactured date at temperatures between +2°C to +8°C.
- DO NOT FREEZE.
- Box: 10 pouches @ 1 Prefilled injection device (Uniject) @ 1 mL
- Box: 10 pouches @ 1 Prefilled injection device (Uniject) @ 0.5 mL
- Box: 100 pouches @ 1 Prefilled injection device (Uniject) @ 0.5 mL Box: 1 vial @ 1 dose @ 1 mL Box: 10 vials @ 1 dose @ 1 mL
- Box: 1 vial @ 2.5 mL
Box: 1 pouch @ 1 Prefilled Injection Device (Uniject) @ 1.0 mL