CETRAXAL Ear drops

Active ingredients: Ciprofloxacin

Product name and form

Cetraxal 2 mg/ml ear drops solution in single-dose container.

Pharmaceutical Form

Ear drops solution in single-dose container.

Clear, sterile, preservative-free aqueous solution.

Qualitative and quantitative composition

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.

Active Ingredient
Description

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.

List of Excipients

Povidone-K-90-F (E1201)
Glycerol (E422)
Purified water
Sodium hydroxide (E524)
Lactic acid (for pH-adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL35533/0130

30/09/2015

Drugs

Drug
Countries
Spain, Singapore, United Kingdom, United States