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Pharmaceutical particulars
List of excipients
Concentrate: EMEM, L-glutamine, Sodium bicarbonate, Hepes, Bovine serum, Dimethyl sulfoxide, Water for injection
Solvent: Sucrose, Casein hydrolisate, Sorbitol, Dipotassium hydrogen phosphate, Potassium dihydrogen phosphate, Phenol red, Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product, except Vectormune ND (where it is marketed) and solvent recommended 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: 30 months
Shelf life after reconstitution according to directions: 2 hours at a temperature below 25°C.
Special precautions for storage
Concentrate:
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
Concentrate:
One Type I glass ampoule containing 1000, 2000 or 4000 doses.
The ampoules are put on canes with tag showing the number of doses and are stored in a liquid nitrogen container.
Solvent:
Polyvinylchloride bag containing 200 ml, 400 ml, 800 ml, 1000 ml, 1200 ml or 1600 ml 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
Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.