Source: FDA, National Drug Code (US) Revision Year: 2020
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg 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 fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. 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. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and 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.
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.
| Dosage Forms and Strengths |
|---|
|
RECOMBIVAX HB is a sterile suspension available in the following presentations:
RECOMBIVAX HB DIALYSIS FORMULATION is a sterile suspension available in the following presentation:
|
| How Supplied |
|---|
|
RECOMBIVAX HB (pediatric and adult) FORMULATION is available in single-dose vials and prefilled Luer-Lok syringes. RECOMBIVAX HB DIALYSIS FORMULATION is available in single-dose vials. Pediatric / Adolescent Formulation (PRESERVATIVE FREE)0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok syringes NDC 0006-4981-00 – box of ten 0.5-mL single-dose vials Color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons NDC 0006-4093-02 – carton of 10 prefilled single-dose Luer-Lok syringes with tip caps Color coded with a yellow plunger rod Adult Formulation (PRESERVATIVE FREE)1 mL (10mcg) in single-dose vials and prefilled Luer-Lok syringes NDC 0006-4995-00 – 1-mL single dose vial Color coded with a green cap and stripe NDC 0006-4995-41 – box of ten 1-mL single-dose vials Color coded with a green cap and stripe NDC 0006-4094-02 – carton of 10 pre-filled single-dose syringes with tip caps Color coded with a green plunger rod RECOMBIVAX HB DIALYSIS FORMULATION1 mL (40mcg) in single-dose vials NDC 0006-4992-00 – 1-mL single-dose vial Color coded with a blue cap and stripe. Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA |
| Drug | Countries | |
|---|---|---|
| RECOMBIVAX HB | Brazil, Canada, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
