Hepatitis B Vaccine [rDNA]

Hepavax-B is indicated for active immunization against infection caused by all known subtypes of Hepavax-B B virus. As Hepavax-B D (caused by the delta virus) does not occur in the absence of Hepavax-B B infection, it can be expected that Hepavax-B D will also be prevented by Hepavax-B B vaccination ... Read more Hepavax-B is indicated for active immunization against infection caused by all known subtypes of Hepavax-B B virus. As Hepavax-B D (caused by the delta virus) does not occur in the absence of Hepavax-B B infection, it can be expected that Hepavax-B D will also be prevented by Hepavax-B B vaccination. Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to Hepavax-B B virus, for example: A baby whose mother is infected can be infected at birth. Children, adolescents, and adults can become infected by:

Contact with blood and body fluids through breaks in the skin such as bites, cuts, or sores

Contact with objects that have blood or body fluids on them such as toothbrushes, razors or monitoring and treatment devices for diabetes

• Having unprotected sex with an infected person
• Sharing needles when injecting drugs
• Being stuck with a used needle
• Household contacts of people infected with Hepavax-B B
• Residents and staff in institutions for the developmental^ disabled
• Kidney dialysis patients
• People who travel to countries where Hepavax-B B is common
• People with HIV infection
• Persons with hemophilia, thalassemia, sickle cell anemia, cirrhosis

Military personnel identified as being at increased risk. Morticians and Embalmers. Prisoners. Users of illicit injectable drugs. Others: Police, fire department personnel, who render first aid or medical assistance, and any others who, through their work or personal life-style, may be exposed to the Hepavax-B B virus.

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 of Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.

Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any Hepatitis B virus containing vaccine.

Hepavax-B is generally well tolerated. Most recipients of Hepavax-B experience some reactions upon vaccination. These are generally moderate and short. They mainly consist of local reactions at the injection site (erythema, induration and tenderness). Systemic reactions (malaise, headache, diarrhea, vomiting, myalgia and elevated temperature) are reported less commonly. In very rare cases allergic type reactions (pruritus, rash, urticaria) may be observed.

The effect of Hepatitis B on fetal development or reproduction capacity has not been evaluated. However, it should only be used during pregnancy when there is a high risk of infection. Adequate human data on use during lactation and adequate animal reproduction studies are not available. It may be administered to nursing mothers only if clearly needed.

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be at +2°C to +8°C. Protect from light. Do not freeze.