Excipients:
Concentrate:
DMSO
Bovine serum
Tryptose
Sucrose
Disodium hydrogen phosphate dihydrate
Potassium dihydrogen phosphate
Sodium chloride
Water for injections
Solvent (Unisolve):
Sucrose
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Sodium chloride
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product except the solvent (Unisolve) supplied for use with the veterinary medicinal product.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
Concentrate: 10 days.
Solvent (Unisolve): in glass vials: 60 months; in PET vials: 18 months.
Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Concentrate:
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Solvent (Unisolve):
Store below 25 °C (if stored separately).
Do not freeze.
Immediate packaging
Vaccine:
Glass vial, hydrolytical class Type I, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap, containing 2 ml (20 doses) or 5 ml (50 doses) of vaccine concentrate.
Solvent (Unisolve):
Glass vial, hydrolytical class Type II, or PET (polyethylene terephthalate) vials, closed with a halogenobutyl rubber stopper and sealed with an aluminium crimp cap containing 40 ml (for 20 doses) or 100 ml (for 50 doses) solvent.
Vaccine, solvent (Unisolve) and a transfer spike packed together or separately.
Pack sizes:
Cardboard box with 1 x vial of 20 doses of vaccine and 1 x vial of 40 ml of solvent and a transfer spike.
Cardboard box with 1 x vial of 50 doses of vaccine and 1 x vial of 100 ml of solvent and a transfer spike.
Cardboard box with 1 x vial of 20 doses of vaccine and a cardboard box with 1 x vial of 40 ml of solvent (add transfer spike if appropriate to either cardboard box).
Cardboard box with 1 x vial of 50 doses of vaccine and a cardboard box with 1 x vial of 100 ml of solvent (add transfer spike if appropriate to either cardboard box).
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater or household waste.
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.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.