|
Indication |
Immunization against polio-virus types 1, 2, and
3 |
|
Proprietary Name |
IPOL |
Orimune (no longer used in US) |
|
Manufacturers |
sanofi pasteur |
Wyeth-Lederly |
|
Viability |
Inactivated |
Live, attenuated |
|
Microorganism |
Single stranded RNA polio virus genus
Enterovirus |
|
Dose |
0.5 mL |
0.5 mL |
|
Route |
Intramuscular or Subcutaneous |
Oral |
|
Dose form |
Suspension |
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, 32D antigen units |
Type 1 Poliovirus, 800000 particules
Type 2 Poliovirus, 100000 particules
Type 3 Poliovirus, 500000 particules |
|
Preservatives |
2-phenoxyethanol, 0.5%
Formaldehyde,
≤
0.02% |
None |
|
Adjuvants |
None |
|
|
Excipients |
Newborn calf serum from bovine spongiform
encephalopathy free countries |
|
|
Allergens |
Neomycin,<5 ng
Streptomycin, 200 ng or Polymyxin, 25 ng
Dry natural latex rubber |
|
|
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 |
Prefilled single-dose syringe (1 and 10 packs
10-dose vial |
Single dose disposable pipettes (1s, 10s, 50s) |
|
Routine storage |
2 to 8°
C (35-46°
F)
Do not freeze |
Freeze |
|
updated July 2005 |