Active ingredients: Ciprofloxacin
Cetraxal 2 mg/ml ear drops solution in single-dose container.
Ear drops solution in single-dose container.
Clear, sterile, preservative-free aqueous solution.
1 ml solution contains 2 mg of ciprofloxacin as hydrochloride.
Each single-dose ampoule delivers 0.25 ml of solution that contains 0.58 mg of ciprofloxacin hydrochloride monohydrate corresponding to 0.50 mg of ciprofloxacin.
For a full list of excipients, see section 6.1.
Ciprofloxacin is a fluoroquinolone antibacterial agent. The bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Povidone-K-90-F (E1201)
Glycerol (E422)
Purified water
Sodium hydroxide (E524)
Lactic acid (for pH-adjustment)
The solution 0.2% is contained within a formed low-density polyethylene (LDPE) ampoule. Each single ampoule delivers 0.25 ml dropwise. The ampoules are contained in an aluminium foil overwrap pouch for protection.
Each pack contains 15 ampoules.
Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
PL35533/0130
30/09/2015