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 the solvent supplied for use with the vaccine.
Shelf life
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Shelf-life of the solvent as packaged for sale: 1 ml and 10 ml glass vials: 4 years.
50 ml PET vials: 2 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 (50 ml PET vial): Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Solvent (1 ml and 10 ml glass vial): No special precautions for storage. Do not freeze.
Immediate packaging
Lyophilisate: Glass vial of 1 or 50 doses with a halogenobutyl rubber stopper and aluminium cap.
Solvent: Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) bottle of 50 ml with a halogenobutyl rubber stopper and aluminium cap.
Packaging:
Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Not all pack sizes may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.