Hepatitis B Vaccine

Product Details:

• Preservative Free
• For Intramuscular Use Only

Product Details:

• rDNA
• Genetically engineered
• It is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration.
• It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus.
• The HBsAg expressed in the cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide.
• The procedures used to manufacture ENGERIX-B result in a product that contains no more than 5% yeast protein.
• Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide.
• Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
• ENGERIX-B is available in vials and prefilled syringes.
• The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex.
• The vial stoppers are not made with natural rubber latex.
• ENGERIX-B is formulated without preservatives.

• Sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 71 mg/mL).

Additional Information:

• Item Code: EBV-01