Vaksin Hepatitis B Rekombinan

DESCRIPTION

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.

COMPOSITION

  • 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.

INDICATION
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
    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.

POSOLOGY
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).

 

SIDE EFFECTS

  • 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 re- lationship with the vaccine has not been established.

CONTRAINDICATION

  • 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 contra-indicate 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 glu- teal 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.
  • See information on vaccine administration (page 87).

DRUG INTERACTION
Not reported.

STORAGE

  • Hepatitis B recombinant vaccine could be stored until 26 months after manufactured date at temperatures between +2°C to +8°C.
  • DO NOT FREEZE.

PRESENTATION

  • 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

HBV®:
Box: 1 pouch @ 1 Prefilled Injection Device (Uniject) @ 1.0 mL