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Pharmaceutical particulars
Excipients
Lyophilisate:
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Shelf-life
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale: 4 years.
Shelf life after reconstitution according to directions: 4 hours.
Special precautions for storage
Lyophilisate:
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
Solvent:
No special precautions for storage.
Immediate packaging
Lyophilisate:
Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Solvent:
Type I clear glass vial of 0.5 ml or 10 ml closed with a bromobutyl rubber stopper and aluminium cap.
Packaging:
- Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 0.5 ml of solvent.
- Plastic box with 25 x 1 dose vial of vaccine and 25 vials containing 0.5 ml of solvent.
- Cardboard box with 10 x 50 dose vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such medicinal product should be disposed of in accordance with local requirements.