|
Indication |
Active immunity against infection caused by
hepatitis A |
|
Proprietary Names |
Havrix |
Vaqta |
|
Manufacturers |
GlaxoSmithKline |
Merck |
|
Viability |
Inactivated |
Inactivated |
|
Microorganism |
Single-stranded RNA human enterovirus 72 genus
Enterovirus |
Single-stranded RNA human enterovirus 72 genus
Enterovirus |
|
Dose |
|
|
|
Adult |
1 mL |
1 mL |
|
Pediatric |
0.5 mL |
0.5 mL |
|
Route |
Intramuscular |
Intramuscular |
|
Dose form |
Suspension |
Suspension |
|
Appearance |
Slightly turbid white suspension after shaking |
Slightly opaque white suspension |
|
Concentration |
|
|
|
Adult |
1440 ELU/mL |
50 U/mL |
|
Pediatric |
720 ELU/0.5mL |
25 U/0.5 mL |
|
Preservatives |
none |
None |
|
Adjuvants: |
|
|
|
Adult |
Aluminum hydroxide, 0.5 mg/mL |
Aluminum hydroxide, 0.45 mg/mL |
|
Pediatric |
Aluminum hydroxide, 0.25/0.5 mL |
Aluminum hydroxide, 0.225 mg/0.5 mL |
|
Excipients |
Amino acid supplement (0.3% w/v) with 0.05 mg/mL
polysorbate-20,
Formalin, ≤0.1 mg/mL
MRC-5 cellular protein, ≤5 mcg |
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 human diploid cell culture |
Human MRC-5 diploid fibroblasts |
|
Packaging |
Single dose vials (0.5 [360 and 720 EL.U] and 1
mL)and prefilled syringes |
Single dose vials (0.5 mL and 1 mL) and
prefilled syringes |
|
Routine Storage |
2 to 8° C (36-46°
F)
Do not freeze |
2 to 8° C (36-46°
F)
Do not freeze |
|
updated
May 2010 |