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HEPATITIS B VACCINE

HEPATITIS B VACCINE

It is a sterile suspension containing formaldehyde-inactivated hepatitis A virus (HM 175 hepatitis A virus strain) adsorbed onto aluminium hydroxide. The virus is propagated in MRC5 human diploid cells. An adult dose is standardised to ensure a viral antigen content of not less than 720 ELISA units of viral antigens, in a 1 ml dose volume. A paediatric dose is standardised to ensure a viral antigen content of not less than 360 ELISA units of viral antigens in a 0.5 ml dose volume.

Indications

Active immunisation against hepatitis A virus infection.


Dosage

Adult: 1 ml/not less than 720 ELISA units. Paediatrics: 0.5 ml/not less than 360 ELISA units. Immunisation schedule: First dose at elected date and second one month later. If necessary, second dose may be administered a minimum of two weeks following the first dose. Booster dose is recommended at any time between 6 & 12 months after initiation of primary course. Vaccine should be used intramuscularly; and in deltoid regions in adult and children.


Contra-Indications

Acute severe febrile illness


Special Precautions

Administer with caution to subjects with thrombocytopenia or a bleeding disorder. Should not be administered intravenously.


Side Effects

Mild headache, malaise, fatigue, fever, nausea and loss of appetite.


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