Excipients
Lyophilisate:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Gelatine
Povidone
Monosodium glutamate
Sodium chloride
Potassium chloride
Sucrose
Water for injections
Solvent:
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium chloride
Potassium chloride
Water for injections
Northern Ireland Excipient Update
Povidone not used as an excipient
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the lyophilisate as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 5 years.
Shelf life after reconstitution: 6 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not store and transport above 25°C.
Immediate packaging
Lyophilisate: Colourless Type I glass bottle closed with a bromobutyl rubber closure and an aluminium cap.
Solvent: Colourless Type I glass bottle (10 ml) or Type II glass bottle (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
Package sizes:
Cardboard box containing 1 bottle with 5 doses of lyophilised tablet and 1 bottle with 10 ml of solvent.
Cardboard box containing 1 bottle with 25 doses lyophilised tablet and 1 bottle with 50 ml of solvent.
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.