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Pharmaceutical particulars
Excipients
Lyophilisate:
Basal B8 medium
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium hydrogen phosphate dihydrate
Solvent:
Disodium hydrogen phosphate dihydrate
Potassium dihydrogen phosphate
Sodium chloride
Sucrose
Water for injections
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 (2 ml): 3 years.
Shelf life of the solvent as packaged for sale (10 ml, 20 ml): 5 years.
Shelf life after reconstitution according to directions: 6 hours.
Special precautions for storage
Lyophilisate:
Store in a refrigerator (2°C – 8°C).
Do not freeze. Protect from light.
Solvent:
Store below 25°C if stored independently from the lyophilisate.
Do not freeze.
Immediate packaging
Lyophilisate:
Type I glass vial of 1, 5, or 10 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Type I glass vial with 2 ml Unisolve and Type II glass vial with 10 ml or 20 ml Unisolve closed with a halogenobutyl rubber stopper and aluminium cap.
Pack sizes:
Cardboard box with:
- 1 dose of lyophilisate + 2 ml of solvent
- 5 doses of lyophilisate + 10 ml of solvent
- 10 doses of lyophilisate + 20 ml of solvent
- 5 x 1 dose of lyophilisate + 5 x 2 ml of solvent
- 5 x 5 doses of lyophilisate + 5 x 10 ml of solvent
- 5 x 10 doses of lyophilisate + 5 x 20 ml of solvent
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.