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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (H's) » Hepatitis B Vaccine


Engerix-B [Hepatitis B Vaccine (Recombinant)] is a soninfectious recombinant DNA hepatitis B vaccine developed and manufactured by Smith Kline Beecham Biologicals. 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 surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed in aluminum hydroxide. The procedures used no manafacture Engerix-B result in a product that contains no more than 5% yeast protein. No substances of human origin are used in its manufacture.

Engerix-B is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration since a fine white deposit with a clear colorless supernatant may form on storage.

Each 1 mL of vaccine consists of 20 mcg of hepatitis B surface antigen adsorbed on 0.5 mg aluminum as aluminum hydroxide. Each 0.5 mL of vaccine consists of 10 mcg of hepatitis B surface antigen adsorbed on 0.25 mg aluminum as aluminum hydroxide. Both formulations contain 120,000 thimerosal (mercury derivative) as a preservative, sodium chloride [9 mg/mL) and phosphate buffer (disodium phosphate dihydrate, 0.98mg/mL, sodium dihydrogen phosphate dihydrate, 0.71 mg/mL)

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