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Pharmaceutical particulars
Excipients
Cell 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 the solvent supplied for use with the medicinal product or Nobilis Rismavac.
Shelf life
Shelf life of the cell concentrate as packaged for sale: 3 years.
Shelf life of the solvent as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Cell 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 in the hatchery.
Immediate packaging
Cell concentrate:
- 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:
- 400 ml multilayer plastic bag.
- 800 ml multilayer plastic bag.
- 1200 ml multilayer plastic bag.
- 1600 ml multilayer plastic bag.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.