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Pharmaceutical particulars
List of excipients
Lyophilisate: Sucrose Suspension: Aluminium hydroxide Sodium chloride Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the suspension supplied for use with the veterinary medicinal product
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after reconstitution according to directions: 8 hours. Until use the reconstituted vaccine should be stored at 2-8 °C.
After removal of the reconstituted vaccine from storage at 2-8 °C, the vaccine should be used immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light. Do not freeze
Nature and composition of immediate packaging
Lyophilisate: 10 ml glass (type I) vials containing 10 or 25 doses
Suspension: 25 ml PET or glass (type I) vials containing 10 doses (20 ml) 50 ml PET or glass (type II) vials containing 25 doses (50 ml)
The vials are closed with bromobutyl rubber stoppers and sealed with aluminium crimp caps.
Pack sizes:
10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (20 ml) of suspension 10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (20 ml) of suspension 25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (50 ml) of suspension.
25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (50 ml) of suspension Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements