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Components of
Hepatitis A and B Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

To induce active immunity against infections caused by either hepatitis A virus or hepatitis B virus in patients 18 years of age and older

Proprietary Name

Twinrix

Manufacturer

Glaxo SmithKline

Viability

Inactivated

Microorganism

HAV and HBV

Dose

1.0 mL

Route

Intramuscular

Dose form

Suspension

Appearance

Slightly turbid white suspension

Concentration

720 ELISA units of HAV and 20 mcg recombinant HBsAg protein

Preservatives

2-phenoxyethanol, 5 mg/mL

Thimerosal, <1 mcg/mL mercury

Adjuvant

Aluminum phosphate and aluminum hydroxide, 0.45 mg/mL

Excipients

Amino acids

Polysorbate-20

Formalin, ≤ 0.1 mg/mL

MRC-5 cellular proteins, residual (≤ 2.5 mcg/mL)

Yeast proteins, ≤ 5%

Neomycin sulfate, ≤ 20 ng/mL

Allergens

Stopper of the vial contains dry natural rubber latex

Media

MRC-5 cells HAV component

S. cerevisiae cells - Strain RIT 4376; HBV component.

Packaging

Vials (single and 10-packs) and prefilled TIP-Lok syringes

Routine Storage

2 to 8 C (36 to 46 F).

Do not freeze

updated November 2005

 

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety