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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 February 12, 2014

2014 Institute for Vaccine Safety