Biological Products

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Product Hepamune? Company SK chemical Life Science Biz.
Classification Vaccine Active Ingredient Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on aluminum as aluminum hydroxide.
Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on aluminum as aluminum hydroxide
Reference Product Approval Date 1998
Indication Hepamune? is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
Description
Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.
Hepamune [Hepatitis B Vaccine (Recombinant)] 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 AB110 cells, which carry the surface antigen gene of the hepatitis B virus.




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