|
Indication |
Immunization against polio-virus types 1, 2, and
3 |
|
Proprietary Name |
IPOL |
|
Manufacturers |
sanofi pasteur |
|
Viability |
Inactivated |
|
Approved Ages
|
6 weeks of age and older
|
|
Dose |
0.5 mL |
|
Route |
Intramuscular or subcutaneous |
|
Dose form |
Suspension |
|
Appearance |
Clear and Colorless |
|
Concentration (per 0.5 mL) |
Type 1 Poliovirus, 40 D antigen units
Type 2 Poliovirus, 8 D antigen units
Type 3 Poliovirus, 32 D antigen units |
|
Excipients |
Newborn calf serum from bovine spongiform
encephalopathy free countries, <1 ppm |
|
Adjuvants |
None |
|
Allergens |
Neomycin,<5 ng
Streptomycin, 200 ng
Polymyxin, 25 ng
Dry natural latex rubber |
|
Preservatives |
2-phenoxyethanol, 0.5%
Formaldehyde,
≤
0.02% |
|
Media |
Vero cells from monkey kidney cells of Vervet or
African green monkeys.
Grown in Eagle MEM modified medium.
For viral growth the culture medium is replaced
by M-199 without calf serum. |
|
Packaging |
Single dose syringe (without needle)
10-dose vial |
|
Routine storage |
2 to 8°
C (35-46°
F)
Do not freeze |
|
Package Insert Date |
December 2005 |
|
updated January 2012 |