metadata toggle
Pharmaceutical particulars
Excipients:
Vaccine:
DMSO
Bovine Serum
Tryptose
Sucrose
Disodium hydrogen phosphate dihydrate
Potassium dihydrogen phosphate
Sodium chloride
Water for injection
Diluent (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 diluent (Unisolve) supplied for use with the product.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
Concentrate: 10 days.
Diluent (Unisolve): in glass vials: 60 months; in PET vials: 18 months.
Shelf life after dilution according to directions: 2 hours
Special precautions for storage
Concentrate:
Store and transport refrigerated (2 to 8°C).
Protect from light. Do not freeze.
Diluent (Unisolve):
Store below 25°C (if stored separately).
Do not freeze.
Immediate packaging
Vaccine:
Type I Ph.Eur. glass vials, 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.
Diluent (Unisolve):
Hydrolytic Type II Ph.Eur. glass, or PET (polyethylene terephthalate) vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 40 ml (for 20 doses) or 100 ml (for 50 doses) diluent.
Vaccine, solvent (Unisolve) and a transfer spike packed together or separately
Pack sizes:
Carton box with 1 x vial of 20 doses of vaccine and 1 x vial of 40 ml of diluent and a transfer spike.
Carton box with 1 x vial of 50 doses of vaccine and 1 x vial of 100 ml of diluent and a transfer spike.
Carton box with 1 x vial of 20 doses of vaccine and a carton box with 1 x vial of 40 ml of diluent (add transfer spike if appropriate to either carton).
Carton box with 1 x vial of 50 doses of vaccine and a carton box with 1 x vial of 100 ml of diluent (add transfer spike if appropriate to either carton).
Not all pack sizes may be marketed
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.