Excipients
Powder
Mannitol
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Sodium hydroxide (for pH adjustment)
Phosphoric acid (for pH adjustment)
Solvent
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injection
Sodium hydroxide (for pH adjustment)
Phosphoric acid (for pH adjustment)
Reconstituted solution
Mannitol
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injection
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after dilution or reconstitution according to directions: 24 hours at 2 – 8 °C.
Special precautions for storage
Storage before reconstitution:
Do not store above 25 °C.
Storage after reconstitution:
Protect from light.
Any veterinary medicinal product not used immediately after reconstitution should be stored refrigerated between 2 °C and 8 °C. Reconstituted product remaining 24 hours after preparation should be discarded safely.
This veterinary medicinal product does not contain an antimicrobial preservative.
Avoid the introduction of contamination during use.
Immediate packaging
Powder: Clear, glass Type I vials with halobutyl rubber bung secured with an aluminium collar.
Solvent: Clear, glass Type I vials with halobutyl rubber bung secured with an aluminium collar.
Pack size: Cardboard box with five vials of 1 500 IU powder and five vials of 5 ml solvent.
Disposal
Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.