CETRAXAL Ear drops (2017)
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Περιεχόμενα
Name of the medicinal product
Cetraxal 2 mg/ml ear drops solution in single-dose container.
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 ...
Pharmaceutical form
Ear drops solution in single-dose container. Clear, sterile, preservative-free aqueous solution.
Therapeutic indications
Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible ...
Posology and method of administration
Adults and children aged one year and older Instil the contents of one single ampoule into the affected ear twice daily for seven days. Paediatric patients less than one year The safety and efficacy of ...
Contraindications
Hypersensitivity to the active substance ciprofloxacin or any member of the quinolone class of antimicrobial agents or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
This medicinal product is for auricular use, not for ophthalmic use, inhalation or injection. In otic use meticulous medical monitoring is required in order to be able to determine in a timely manner the ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Cetraxal. Due to low plasma level anticipated after application in the ear, it is unlikely that ciprofloxacin may show systemic interaction with other drugs. ...
Fertility, pregnancy and lactation
Pregnancy There are no data on the use of ciprofloxacin otic solution 0.2% in pregnant women. There are moderate amount of data from the use oral ciprofloxacin in pregnant women. No reproductive toxicity ...
Effects on ability to drive and use machines
Cetraxal has no or negligible influence on the ability to drive and use machines.
Undesirable effects
In a Phase III clinical trial, a total of 319 patients were treated with Cetraxal. The most commonly reported adverse reactions are: ear pruritus occurring in 0.9% of patients treated with ciprofloxacin, ...
Overdose
The potential risk of overdose with this single-dose preparation is negligible since the total amount of ciprofloxacin per pack is 7.5 mg.
Pharmacodynamic properties
Pharmacotherapeutic group: Sensory organs. Otologicals. Antiinfectives. ATC code: S02AA15 Mechanism of action As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results ...
Pharmacokinetic properties
The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 ml Cetraxal 0.2% (total dose: 0.5 mg ciprofloxacin). It is expected that systemic plasma levels will be no ...
Preclinical safety data
No significant findings were seen in carcinogenicity or reproductive and developmental toxicity studies. Ciprofloxacin is well tolerated when applied to both intact and abraded skin in the external ear ...
List of excipients
Povidone-K-90-F (E1201) Glycerol (E422) Purified water Sodium hydroxide (E524) Lactic acid (for pH-adjustment)
Incompatibilities
Not applicable.
Shelf life
2 years. The ampoule contents should be used immediately after opening the single dose ampoule. Any unused contents should be discarded. Shelf-life after first opening of the pouch: 8 days.
Special precautions for storage
Store below 30°C. Store in the original packaging in order to protect from light.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Marketing authorization number(s)
PL35533/0130
Date of first authorization / renewal of the authorization
30/09/2015
Date of revision of the text
31/10/2017
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