Excipients
Lyophilisate:
Veggie medium
Hydrolysed gelatin
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent (Unisolve):
Disodium 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 veterinary medicinal product as packaged for sale:
Lyophilisate: 2 years.
Solvent (2 ml): 3 years.
Solvent (10, 20, 40, 100 ml): 5 years.
Shelf life after reconstitution according to directions: 24 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.
Reconstituted vaccine:
Store at room temperature.
Immediate packaging
Lyophilisate:
Type I glass vial with 1, 5, 10, 20 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Type I glass vial with 2 ml Unisolve closed with a halogenobutyl rubber stopper and aluminium cap.
Type II glass vial with 10 ml, 20 ml, 40 ml or 100 ml Unisolve closed with a halogenobutyl rubber stopper and aluminium cap.
Pack sizes:
Cardboard box with:
- 1 dose of lyophilisate + 2 ml solvent
- 5 doses of lyophilisate + 10 ml solvent
- 10 doses of lyophilisate + 20 ml solvent
- 5 x 1 dose of lyophilisate + 5 x 2 ml solvent
- 5 x 5 doses of lyophilisate + 5 x 10 ml solvent
- 5 x 10 doses of lyophilisate + 5 x 20 ml solvent
- Cardboard box with 20 doses of lyophilisate + cardboard box with 40 ml solvent
- Cardboard box with 50 doses of lyophilisate + cardboard box with 100 ml 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.