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Pharmaceutical particulars
Excipients
Vaccine only:
Monosodium glutamate
Sucrose
Bovine serum albumin
Water for injection.
Unisolve
Sucrose,
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Sodium chloride
Water for Injection
Major incompatibilities
Do not mix with any other veterinary medicinal product except the solvent, Unisolve.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Solvent in glass vials: 5 years and in PET vials: 18 months.
Shelf life after dilution or reconstitution according to directions: 2 hours.
Special precautions for storage
Vaccine:
Store and transport refrigerated (2°C - 8°C).
Do not freeze. Protect from light.
Solvent:
Store below 25 °C (if stored separately). Do not freeze.
Immediate packaging
Carton with 1 vial of vaccine and 1 vial of Unisolve and one transfer spike.
Vaccine:
Type I Ph.Eur. glass vial, closed with a rubber stopper and sealed with a colour coded aluminium cap, containing a freeze dried plug of vaccine (10, 20, 50 or 100 doses) with the appropriate volume of solvent.
Solvent:
Type II glass vials (Ph. Eur) containing 20, 40, 100 or 200 ml closed with a halogenated butylrubber stopper and an aluminium crimp cap.
Polyethylene terephthalate (PET) vials containing 40 or 100 ml closed with a halogenated butylrubber stopper and an aluminium crimp cap.
Not all pack sizes may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.