List of excipients
Powder vial:
Silica colloidal anhydrous
Solvent vial:
Potassium dihydrogen phosphate (for pH adjustment)
Sodium citrate (for pH adjustment)
Povidone
Water for injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf life after reconstitution according to directions: 24 hours.
Special precautions for storage
Before reconstitution, the powder and solvent vials do not require any special storage conditions.
The reconstituted suspension should be stored in the refrigerator (2-8°C).
Nature and composition of immediate packaging
Carton box containing either:
5 MIU presentation
Powder vial: 25 ml type I colourless glass vial closed with a bromobutyl stopper and sealed with an aluminium flip-top seal
Solvent vial: 20 ml type II colourless glass vial closed with a bromobutyl stopper and sealed with an aluminium flip-top seal or
10 MIU presentation
Powder vial: 50 ml type II colourless glass vial closed with a bromobutyl stopper and sealed with an aluminium flip-top seal.
Solvent vial: 50 ml type II colourless glass vial closed with a bromobutyl stopper and sealed with an aluminium flip-top seal
Pack sizes:
5,000,000 IU powder vial and 18 ml solvent vial
5,000,000 IU powder vial and 18 ml solvent vial x 5
5,000,000 IU powder vial and 18 ml solvent vial x 10
10,000,000 IU powder vial and 36 ml solvent vial
10,000,000 IU powder vial and 36 ml solvent vial x 5
10,000,000 IU powder vial and 36 ml solvent vial x 10
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.