Pharmaceutical Formulation: Emulsion for Injection
Name and brief description of the veterinary biological product: COLIDOLL is an oil adjuvanted and inactivated vaccine used in pregnant cows to protect newborn calves from E. coli infections.
Names and strength of active substances and names and quantities of other excipients:
The quantities in each dose (2 ml) are as follows:
|E.coli EC (O1O1: H-K99+F41+) strain||1×1010 cfu/dose*||Antigen|
|E.coli 11A (O?:H-K99+:, F(Y)+) strain||1×1010 cfu/dose*||Antigen|
|Oil adjuvant (Montanide ISA)||1 ml||Adjuvant|
|Formaldehyde (37%)||2 μl||Inactivator|
|Water for injection||Max. 1 ml||Volume supplement|
* Colony count before inactivation
Administered to pregnant cows to protect newborn calves against diarrhea caused by Escherichia coli.
- The vaccine is administered with subcutaneous injection of 2 ml into the immobile area behind the shoulder.
- The administration dose is 2 ml.
- Should be administered 4-6 weeks before calving.
Stored at +2/8ºC, and in the dark. Do not freeze. Shelf life is 2 years.
Withdrawal period is 0 days.
The vaccines are packaged as boxed in 6 ml amber colored Type I glass vials containing 1 and 2 doses, or as unboxed but placed in 10-unit plastic trays wrapped in styrofoam; and in 10, 20, 50 and 100 ml amber colored Type II glass vials containing 5, 10 (boxed/unboxed), 25 and 50 doses.
Not all forms of packaging may be placed on the market. The vials are placed on the market as boxed in 50 or 100-unit styrofoam trays which contain the same number of leaflets.