Source: FDA, National Drug Code (US) Revision Year: 2020
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious 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 contains the following excipients: Sodium chloride (8 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.9 mg/mL; sodium dihydrogen phosphate dihydrate, 0.7 mg/mL).
ENGERIX-B is available in vials (adult dose only) and prefilled syringes. The tip caps of the prefilled syringes 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.
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ENGERIX-B is a sterile suspension available in the following presentations:
[See Description (11), How Supplied/Storage and Handling (16)] |
| How Supplied |
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ENGERIX-B (preservative-free formulation) is available in prefilled disposable TIP-LOK syringes (packaged without needles) (pediatric/adolescent and adult doses) and single-dose vials (adult dose only). 10 mcg/0.5 mL Pediatric/Adolescent Dose: NDC 58160-820-43 Syringe in Package of 10: NDC 58160-820-52 20 mcg/mL Adult Dose: NDC 58160-821-01 Vial in Package of 10: NDC 58160-821-11 Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, U.S. License No. 1617 Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709 |
| Drug | Countries | |
|---|---|---|
| ENGERIX-B | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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