Date shown reflects the date that the evidence was documented
2022-01-19
Hepatitis-B-Vaccine-package-insert-recombivax-hb
"RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How
Supplied/Storage and Handling (16).]
Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains
5 mcg of hepatitis B surface antigen.
Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of
hepatitis B surface antigen.
Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of
hepatitis B surface antigen.
All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum
hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each
formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as
amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL
residual formaldehyde. The vaccine is of the adw subtype."
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/package-insert-recombivax-hb.pdf
https://www.fda.gov/media/119403/download
Hepatitis-B-Vaccine-package-insert-recombivax-hb
"RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. [See How
Supplied/Storage and Handling (16).]
Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains
5 mcg of hepatitis B surface antigen.
Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of
hepatitis B surface antigen.
Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of
hepatitis B surface antigen.
All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum
hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each
formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as
amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL
residual formaldehyde. The vaccine is of the adw subtype."
https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/package-insert-recombivax-hb.pdf
https://www.fda.gov/media/119403/download