Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution in single-dose container.
| Pharmaceutical Form |
|---|
|
Ear drops, solution in single-dose container (ear drops). Colourless or slightly yellow, clear aqueous solution. |
Each ml of solution contains ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin and 0.25 mg of fluocinolone acetonide.
Each single-dose container (0.25 ml) delivers 0.75 mg of ciprofloxacin and 0.0625 mg of fluocinolone acetonide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ciprofloxacin |
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. |
|
| Fluocinolone |
Fluocinolone acetonide is a synthetic fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. |
| List of Excipients |
|---|
|
Polysorbate 80 |
The solution is contained within a formed low-density polyethylene (LDPE) single-dose container. Each single-dose container delivers 0.25 ml.
The single-dose containers are contained in an aluminium foil overwrap pouch for protection. Each pack contains 15 single-dose containers.
Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
PL35533/0133
23/07/2018
| Drug | Countries | |
|---|---|---|
| CETRAXAL PLUS | Ecuador, Spain, Hong Kong, Malta, Poland, United Kingdom |
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