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Pharmaceutical particulars
List of excipients
Frozen virus suspension:
EMEM, L-glutamine, Sodium bicarbonate, Hepes, Bovine serum, Dimethyl sulfoxide, Water for injection
Solvent (Cevac Solvent Poultry):
Sucrose, Casein hydrolisate, Sorbitol, Dipotassium hydrogen phosphate, Potassium dihydrogen phosphate, Phenol red, Water for injection
Incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent (Cevac Sovent Poultry) supplied for use with the product.
Shelf life
Shelf life of the frozen virus suspension, as packaged for sale: 2 years.
Shelf life of the solvent, as packaged for sale: 30 months.
Shelf life after reconstitution according to directions: 2 hours at a temperature below 25°C.
Special precautions for storage
Frozen virus suspension:
Store and transport frozen in liquid nitrogen (-196°C).
The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed. Store liquid nitrogen container securely in upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room in the hatchery.
Solvent:
Store below 25°C. Do not freeze.
Nature and composition of immediate packaging
Frozen suspension (not reconstituted vaccine):
One type I glass ampoule of 2ml containing 500, 1000, 2000 or 4000 doses of the vaccine. Ampoules are put on cane, supplied with tag showing the numbers of doses. The canes with ampoules are stored in a liquid nitrogen container.
Solvent:
Polyvinylchloride bag containing 200 ml, 400 ml, 800 ml, 1000 ml, 1200 ml or 1600ml in individual over-pouch.
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.
Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.
Do not re-use opened containers of diluted vaccine.