List of excipients
Lyophilisate: Veggie medium, Sorbitol, Monosodium glutamate, Glycine, Amine#1, Disodium phosphate dihydrate, Water for injections
Solvent: Sucrose, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Sodium chloride, Water for injections
Incompatibilities:
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product or with Bovilis BVD (for revaccination only).
Shelf life:
Shelf life of the veterinary medicinal product as packaged for sale:
Lyophilisate: 36 months.
Solvent: in glass vials: 60 months; in PET vials: 18 months.
Shelf life after reconstitution according to directions: 3 hours.
Special precautions for storage
Lyophilisate:
Store in a refrigerator (2 °C to 8 °C).
Do not freeze.
Protect from light.
Solvent:
Store below 25 °C if stored independently from the lyophilisate.
Do not freeze.
Nature and composition of immediate packaging
Lyophilisate:
Vials of glass (hydrolytic type I) closed with a rubber stopper and metal cap.
Solvent:
Vials of glass (hydrolytic type II) or plastic (polyethylene terephthalate) closed with a rubber stopper and metal cap. Solvent may be packed together with the lyophilisate or separately.
Pack sizes:
Cardboard box with 1 glass vial of lyophilisate (5 doses) and 1 glass vial of solvent (10 ml).
Cardboard box with 1 glass vial of lyophilisate (10 doses) and 1 glass vial of solvent (20 ml).
Cardboard box with 1 glass vial of lyophilisate (25 doses) and 1 glass vial of solvent (50 ml).
Cardboard box with 1 glass vial of lyophilisate (50 doses) and 1 glass vial of solvent (100 ml).
Cardboard box with 1 glass vial of lyophilisate (50 doses) and 1 PET vial of solvent (100 ml).
Cardboard box with 1 glass vial of lyophilisate (100 doses) and 1 glass vial of solvent (200 ml).
Cardboard box with 10 glass vials of lyophilisate (5 doses) and a cardboard box with 10 glass vials of solvent (10 ml).
Cardboard box with 10 glass vials of lyophilisate (10 doses) and a cardboard box with 10 glass vials of solvent (20 ml).
Cardboard box with 10 glass vials of lyophilisate (25 doses) and a cardboard box with 10 glass vials of solvent (50 ml).
Cardboard box with 10 glass vials of lyophilisate (50 doses) and a cardboard box with 10 glass vials of solvent (100 ml).
Cardboard box with 10 glass vials of lyophilisate (50 doses) and a cardboard box with 10 PET vials of solvent (100 ml).
Cardboard box with 10 glass vials of lyophilisate (100 doses) and a cardboard box with 10 glass vials of solvent (200 ml).
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.