Excipients
Powder vial:
None.
Solvent vial:
Benzyl alcohol
Carmellose sodium
Poloxamer 124
Disodium phosphate dihydrate
Hydrochloric acid, concentrated
Sodium hydroxide
Water for injections
Reconstituted suspension:
Benzyl alcohol
Carmellose sodium
Poloxamer 124
Disodium phosphate dihydrate
Hydrochloric acid, concentrated
Sodium hydroxide
Water for injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 3 months.
Special precautions for storage
This veterinary medicinal product does not require any special temperature storage conditions.
After reconstitution, store below 30 ºC. Do not freeze the suspension.
Immediate packaging
Type I glass vials closed with bromobutyl rubber stoppers and aluminium flip-off caps.
Each cardboard box contains 1, 2, 5 or 10 sets of a fluralaner powder vial (2.51 g fluralaner), a solvent vial (16 ml solvent), and a sterile 25 G vent needle.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
The veterinary medicinal product should not enter water courses as fluralaner may be dangerous for fish and other aquatic organisms.