Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
PROTEIN (HBsAg)
MSD PHARMA (SINGAPORE) PTE. LTD.
J07BC01
10 MCG/ML
INJECTION
PROTEIN (HBsAg) 10 MCG/ML
INTRAMUSCULAR
Prescription Only
Merck Sharp & Dohme LLC
ACTIVE
2005-04-14
SG- HB2-I- 122011 PHYSICIANS CIRCULAR Injection HBVAXPRO ® (hepatitis B vaccine [recombinant] thimerosal-free, MSD) HBvaxPRO ® (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast _Saccharomyces cerevisiae_ containing the gene for the _adw_ subtype of HBsAg. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. Each dose contains less than 1% yeast protein. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide). The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. Each lot of hepatitis B vaccine is tested for sterility. HBvaxPRO is a sterile suspension for intramuscular injection; however, it may be administered subcutaneously to persons at risk of hemorrhage following intramuscular injections (see DOSAGE AND ADMINISTRATION). HBvaxPRO (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is supplied in three formulations: Pediatric/ Adolescent Formulat Lue koko asiakirja
SG-V232-I-052018 PHYSICIANS CIRCULAR Injection HBvaxPRO® (hepatitis B vaccine [recombinant] thimerosal-free, MSD) HBvaxPRO® (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is a non-infectious subunit viral vaccine consisting of surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. Each dose contains less than 1% yeast protein. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide). The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of protective efficacy (chimpanzee and human). The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. Each lot of hepatitis B vaccine is tested for sterility. HBvaxPRO is a sterile suspension for intramuscular injection; however, it may be administered subcutaneously to persons at risk of hemorrhage following intramuscular injections (see DOSAGE AND ADMINISTRATION). HBvaxPRO (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is supplied in three formulations: • Pediatric/Adolescent Formulation, 5 mcg of hepatitis B surface antigen in 0.5 mL dose; • Adult Formulation, 10 mcg of hepatitis B surface antigen in 1.0 mL dose; • Dialysis Formulation, 40 mcg of Lue koko asiakirja