List of excipients
Vaccine concentrate:
Dimethyl sulfoxide
199 Earle medium
Sodium hydrogen carbonate
Hydrochloric acid
Water for injections
Solvent:
Sucrose
Casein hydrolysate
Phenolsulfonphthalein (Phenol red)
Dipotassium phosphate
Potassium dihydrogen phosphate
Sodium hydroxide or hydrochloric acid
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 2 years.
Shelf life after vaccine preparation according to directions: 2 hours at a temperature below 25°C.
Special precautions for storage
Vaccine concentrate:
Store and transport frozen in liquid nitrogen.
The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.
Discard any ampoules that have been accidentally thawed.
Solvent:
Store below 30°C. Do not freeze. Protect from light.
Nature and composition of immediate packaging
Vaccine concentrate:
•Type I glass ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
•Type I glass ampoule of 2,000 doses of vaccine, 5-ampoule carrier.
•Type I glass ampoule of 4,000 doses of vaccine, 4-ampoule carrier.
The ampoule carriers are stored firstly in canisters and these canisters are then stored latter in the liquid nitrogen containers.
Solvent:
Polyvinylchloride bag containing 200 ml, 400 ml, 600 ml, 800 ml, 1,000 ml, 1,200 ml, 1,600 ml, 1,800 ml or 2,400 ml.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.