Dosage

Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is >10 mcg of antigen protein in 0.5 ml.Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is >20 mcg of antigen in 1 ml.Primary immunization schedule for all ages:The usual immunization schedule consists of 3 doses of vaccine-

First dose: at elected date
Second dose: 1 month after first dose
Third dose: 6 months after first dose

or accelerated schedule consists of 4 doses of vaccine-

First dose: at elected date
Second dose: 1 month after first dose
Third dose: 2 months after first dose
Fourth dose: 12 months after first dose

Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:

First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
Second dose: 1 month after first dose
Third dose: 2 months after first dose
Fourth dose: 12 months after first dose

For travellers departing within 1 month, adult over 18 years,

First dose: at elected date
Second dose: 7 days after first dose
Third dose: 21 days after first dose
Fourth dose: 12 months after first dose

Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms-

First dose: at the appropriate date
Second dose: 1 month after first dose
Third dose: 2 months after first dose
Fourth dose: 6 months after first dose

Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses ofHepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.

Administration

Method of administration: Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously. Hepatitis B Vaccine should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.Preparation for administration: The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously. The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. The vaccine should be used as supplied; no dilution is necessaryCo-administration: Hepatitis B vaccine can be given at the same time with other vaccine as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae b, Hepatitis A and BCG vaccines at separate sites and with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.