Excipients
Lyophilisate: Monosodium glutamate, Sucrose, Bovine serum albumin, Water for injections.
Solvent (Unisolve): Sucrose, Potassium dihydrogen phosphate, Disodium hydrogen 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
Lyophilisate: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Solvent: Shelf life of the veterinary medicinal product as packaged for sale: in glass vials: 5 years
and in PET vials: 18 months.
Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Lyophilisate:
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
Lyophilisate:
Type I 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) for use with the appropriate volume of solvent.
Solvent (Unisolve):
Type II glass vial containing 20, 40, 100 or 200 ml solvent closed with a halogenated butylrubber stopper and an aluminium crimp cap.
Polyethylene terephthalate (PET) vial containing 40 or 100 ml solvent closed with a halogenated butylrubber stopper and an aluminium crimp cap.
Pack sizes
Cardboard box with one vial of lyophilisate 10, 20, 50 or 100 doses and one vial of solvent 20, 40, 100 or 200 ml (Unisolve) respectively and a transfer spike.
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 approved for use by the competent authorities.