CILOXAN Eye drops, solution (2017)
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Περιεχόμενα
Name of the medicinal product
CILOXAN 0.3% w/v eye drops, solution.
Qualitative and quantitative composition
Ciprofloxacin 0.3% w/v (as hydrochloride). Excipients with known effect: One ml of solution contains 0.06mg of benzalkonium chloride. For a full list of excipients, see Section 6.1.
Pharmaceutical form
Eye drops, solution. A clear and colourless to pale yellow solution.
Therapeutic indications
Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12-16 years). CILOXAN is indicated for the treatment of corneal ulcers and superficial ...
Posology and method of administration
Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12-16 years). Corneal Ulcers CILOXAN must be administered in the following intervals, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1. Hypersensitivity to quinolones.
Special warnings and precautions for use
After cap is removed, if tamper evident snap collar is loose, remove before using product. For ocular use only. The clinical experience in children less than one year old, particularly in neonates is very ...
Interaction with other medicinal products and other forms of interaction
Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. Given the low systemic concentration of ciprofloxacin following topical ocular administration of the product, drug ...
Fertility, pregnancy and lactation
Fertility Studies have not been performed in humans to evaluate the effect of topical administration of ciprofloxacin on fertility. Oral administration in animals does not indicate direct harmful effects ...
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive or use machines. Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient ...
Undesirable effects
In clinical trials, the most frequently reported adverse drug reactions were ocular discomfort, dysgeusia and corneal deposits occurring approximately in 6%, 3% and 3% of patients respectively. Tabulated ...
Overdose
A topical overdose of CILOXAN may be rinsed out from the eye(s) with lukewarm tap water. Due to the characteristics of this preparation no toxic effects are to be expected with an ocular overdose of this ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Ophthalmologicals, Other Antiinfectives ATC Code: S01AX13 Mechanism of Action CILOXAN eye drops, solution contains the fluoroquinolone ciprofloxacin. The cidal and inhibitory ...
Pharmacokinetic properties
CILOXAN eye drops, solution is rapidly absorbed into the eye following topical ocular administration. Systemic levels are low following topical administration. Plasma levels of ciprofloxacin in human subjects ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Non-clinical developmental ...
List of excipients
Benzalkonium chloride Disodium edetate Mannitol Glacial acetic acid Sodium acetate Hydrochloric acid/sodium hydroxide Purified water
Incompatibilities
Incompatible with alkaline solutions.
Shelf life
Unopened 24 months, after opening 28 days.
Special precautions for storage
Store upright. Do not store above 25°C. Do not refrigerate or freeze.
Nature and contents of container
5 ml Drop-Tainer LDPE bottle and plug with a polystyrene or polypropylene cap.
Special precautions for disposal and other handling
Discard product 28 days after first opening.
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Marketing authorization number(s)
PL 00101/0994
Date of first authorization / renewal of the authorization
23 November 1993 / 17 February 2004
Date of revision of the text
01 May 2017
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