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Pharmaceutical particulars
Excipients
Concentrate:
Bovine serum
Veggie medium
Dimethyl sulfoxide
Solvent:
Sucrose
Sodium chloride
Disodium hydrogen phosphate dihydrate
Phenolsulfonphthalein (Phenol red)
Potassium dihydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except Nobilis Rismavac and the solvent supplied for use with the medicinal product.
Shelf-life
Shelf life of the cell concentrate as packaged for sale: 3 years.
Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Concentrate:
Store and transport frozen in liquid nitrogen (below -140°C).
Solvent:
Store below 30°C.
Container:
Store liquid nitrogen container securely in upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room.
Immediate packaging
Cell concentrate:
- One Type I glass ampoule of 2 ml containing 2,000 or 4,000 doses. Ampoules are stored on a cane and attached to the cane is a coloured clip displaying the dose (2,000 doses: salmon-pink coloured clip, and 4,000 doses: yellow coloured clip).
Solvent:
- One 400 ml multilayer plastic bag.
- One 800 ml multilayer plastic bag.
- One 1200 ml multilayer plastic bag.
- One 1600 ml multilayer plastic bag.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.