|
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 |