Components of

Hepatitis A Vaccine

Components Page
Excipients Table
Allergens Table
     
Name Harix Vaqta
Manufacturer GlaxoSmithKline Merck
Viability Inactivated Inactivated
Indicated Ages 12 months and older 12 months and older
Dose Children/Adolescents: 0.5 mL
Adults: 1 mL
Children/Adolescents: 0.5 mL
Adults: 1 mL
Schedule 2 doses 2 doses
Route Intramuscular Intramuscular
Appearance White Slightly opaque, white
Concentration 1440 ELU/1mL 50 U/mL
Preservative None None
Adjuvant Aluminum hydrox Aluminum hydrox
Excipients • Amino acid supplement , 0.3% w/v
• Phosphate-buffered saline solution
• Polysorbate 20, 0.05 mg/mL
• MRC-5 cell proteins, ≤5 mcg/mL
• Formalin, ≤1 mcg/mL
• Neomycin sulfate, ≤40 ng/mL
• Nonviral protein, <0.1 mcg
• DNA, <4 x 10-6 mcg
• Formaldehyde,<0.8 mcg
• Bovine albumin, <10-4
Allergens • Neomycin sulfate, <40 ng/mL
• Stopper of the vial contains dry natural rubber latex
None
Media MRC-5 MRC-5
Packaging • Vial, 10-pack
• Syringe, 10-pack
• Vial, single pack
• Syringe, single pack
• Single -dose vials
• Prefilled syringes
Storage 2-8C (36-46F)
Do not freeze.
2-8C (35-46F)
Do not freeze
PI date May 2016 February 2014
    table last updated 3/9/18