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 Approved Ages 18 years and older 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 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 2-phenoxyethanol, 5 mg/mL Thimerosal, <1 mcg/mL mercury Aluminum phosphate and aluminum hydroxide, 0.45 mg/mL Adjuvant Aluminum phosphate and aluminum hydroxide, 0.45 mg/mL Allergens Neomycin sulfate, ≤ 20 ng/mL Stopper of the vial contains dry natural rubber latex Preservatives 2-phenoxyethanol, 5 mg/mL Thimerosal, <1 mcg/mL mercury 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 Package Insert Date March 2012 updated January 2012
This page was last updated on May 01, 2012 © 2012 Institute for Vaccine Safety