|
Indication |
Active immunity against vaccinia and smallpox |
|
Proprietary Name |
ACAM2000 |
|
Manufacturer |
Sanofi Pasteur |
|
Viability |
Live attenuated |
|
Microorganism |
Vaccinia virus. Note: This vaccine does not contain smallpox virus (variola) and cannot spread or cause smallpox. |
|
Approved Ages |
All age groups
link to approval letter
|
|
Dose |
0.0025 mL administered using 15 jabs of a bifurcated needle dipped into the vaccine |
|
Route |
Percutaneous (scarification) |
|
Appearance |
Clear to slightly hazy, colorless to straw-colored |
|
Concentration |
2.5 x 105 plaque-forming units |
|
Excipients |
HEPES, 6-8 mM
Human serum albumin, 2%
Sodium chloride, 0.5 – 0.7%
Mannitol, 5%
Neomycin, trace amounts
Polymyxin B, trace amounts
|
|
Adjuvant |
None |
|
Allergens |
Neomycin, trace amounts
Polymyxin B, trace amounts
|
|
Preservatives |
Phenol 0.25% |
|
Media |
African Green Monkey kidney (Vero) cells |
|
Packaging |
Vials, multiple-dose 3 mL clear glass vials containing lyophilized powder
Diluent, in 3 mL clear glass vials containing 0.6 mL of diluent |
|
Routine Storage |
2 to 8°
C
Shipped at 0°
C or cooler |
|
Package Insert updated |
September 2009
|
|
updated January
2012 |