Components of Hepatitis B Vaccines	Excipients Table Allergens Table Components Table
Indication Induction of active immunity against hepatitis B virus Proprietary Name Engerix-B Recombivax HB Manufacturers GlaxoSmithKline Merck Viability Inactivated Inactivated Microorganism Double-stranded DNA hepatitis virus family Hepadnaviridae Double-stranded DNA hepatitis virus family Hepadnaviridae Dose:     Adult 20 mcg/mL 10 mcg/mL Pediatric 10 mcg/0.5 mL 5 mcg/0.5 mL Dialysis   40 mc/mL Route Intramuscular Intramuscular (for persons at risk of hemorrhage, can be Subcutaneous) Dose form Suspension Suspension Appearance Slightly Turbid White Suspension Slightly opaque white after agitation Concentration 20 mcg/mL 10 or 40 mcg/mL depending on package Preservatives: Trace amount of Thimerosal None Adult < 1 mcg/mL mercury   Pediatric < 0.5 mcg/mL mercury   Adjuvant Aluminum Hydroxide, ≤ 0.5 mg/mL Aluminum Hydroxide, ≤ 0.5 mg/mL Excipients Disodium phosphate, 0.98 mg/mL Sodium dihydrogen phosphate, 0.71 mg/mL None Allergens Yeast protein, <5% or plasmid DNA Yeast protein, <1% Media Saccharomyces cerevisiae Saccharomyces cerevisiae grown in fermentation medium consisting of yeast, soy peptone, dextrose, amino acids, and mineral salts Packaging Vials and Prefilled TIP-LOK syringes 0.5 mL and 1 mL single-dose vials Routine Storage 2 to 8° C (36 to 46° F). Do not freeze 2 to 8° C (36 to 46° F). Do not freeze updated July 2005
This page was last updated on January 23, 2008 © 2004 Institute for Vaccine Safety