Engerix-B

• Active immunization against Hepatitis B virus infection

Hepatitis B Vaccine is a noninfectious recombinant DNA Hepatitis B vaccine. It is a sterile suspension of purified surface antigen of hepatitis B virus obtained by culturing genetically engineered yeast cells (Saccharomyces cerevisiae cells), which carry the gene that codes for the HBsAg. The HBsAg protein expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminium hydroxide.

Adult & Child Dose:

• Neonates-19 years: 0.5 ml (10 mcg antigen)
• 19 years and older: 1 ml (20 mcg antigen)

Usual schedule (0, 1, 6 months):

• 1st dose: at elected date
• 2nd dose: 1 month after first dose
• 3rd dose: 6 months after first dose

Accelerated schedule (0, 1, 2, 12 months):

• 1st dose: at elected date
• 2nd dose: 1 month after first dose
• 3rd dose: 2 months after first dose
• 4th dose: 12 months after first dose

HBsAg-positive mother's neonate: 4 doses of 10 mcg (birth, 1, 2 and 12 months)

Renal insufficiency (haemodialysis): 4 doses of 40 mcg

* Use as directed by the registered physician

Common Side Effects (>10%):

• Pain (10-29%)
• Pruritus (10-29%)
• Erythema (10-29%)
• Burning (10-29%)
• Nodules (10-29%)
• Fatigue (15%)
• Headache (15%)
• Fever (15%)

1-10%: Lightheadedness, Flushing, Insomnia, Irritability, Arthralgia, Constipation

Use in Pregnancy: Adequate human data on use during pregnancy is not available. Use only when clearly needed and when possible advantages outweigh possible risks.

Precautions:

• Alcohol or disinfectant used for skin cleansing should be allowed to evaporate before vaccination (to prevent inactivation of live vaccines)
• Shake well before use
• Inspect visually prior to administration

Overdose: Limited information available on overdose. Employ usual supportive measures.

Storage: Store at 2°C-8°C. Do not freeze. Protect from light.