Inactivated Botulism Vaccine
Botudoll Prospectus
BOTUDOLL
Pharmaceutical Formulation: Solution for Injection
BOTUDOLL is used to protect cattle, sheep and goats against Botulism, caused by Cl. botulinum type C and Cl. botulinum type D.
Sheep, goat, cattle
Ingredients | Quantity |
Cl. botulinum type C | ≥ 80% Protection* |
Cl. Botulinum type D | ≥ 80% Protection* |
Aluminum hydroxide gel | 15% |
Formaldehyde (of 37%) | ≤ 0,8% |
Phenol (of 80%) | ≤ 0,32% |
* Antitoxin potency where at least 80% of the vaccinated mice are protected against 25 paralytic doses of Cl. botulinum type C and type D toxins.
BOTUDOLL is used to protect cattle, sheep and goats against Botulism, caused by Cl. botulinum type C and Cl. botulinum type D.
The vaccine is administered with subcutaneous injection of 2 ml into the immobile area behind the shoulder in cattle, and 1 ml into the immobile area on axilla in sheep and goats. Animals to be vaccinated for the first time, should be given a second injection 4-6 weeks later. In order to maintain a high level of immunity, single-dose vaccinations should be administered every year. In predisposed conditions of high risk of disease, a single dose vaccination is recommended after 6 months. Cattle, sheep and goats can be vaccinated as of 3 months of age.
Should be stored at + 2/8ºC, and in the dark. Do not freeze. Shelf life is 24 months. Opened vials should be used within 6-8 hours.
The vaccine is packaged in 20, 50, and 100 ml amber colored type II glass bottles, and 50, 100, 200 and 250 ml plastic bottles, containing 10, 25, 50, 100 and 125 cattle doses or 20, 50, 100, 200 and 250 sheep and goat doses. Glass and plastic bottles are labeled as closed with the same butyl stoppers and aluminum caps. Vaccine vials are available on the market as 20 ml, 50 ml, 100 ml, 200 ml and 250 ml glass and plastic vials either placed in single-unit cardboard boxes or unboxed packaged in styrofoam. Not all forms of packaging may be placed on the market.
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