EXOCIN Eye drops, solution (2016)
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Περιεχόμενα
Name of the medicinal product
EXOCIN 3 mg/ml Eye Drops, Solution.
Qualitative and quantitative composition
One millilitre contains 3 mg ofloxacin. For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, solution. Clear, pale to light yellow-green solution, practically free from visible particles.
Therapeutic indications
EXOCIN is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) in adults and children caused by ofloxacin sensitive organisms. Safety and ...
Posology and method of administration
Topical ocular instillation. For all ages: one to two drops in the affected eye(s) every two to four hours for the first two days and then four times daily. The length of treatment should not exceed ten ...
Contraindications
EXOCIN is contra-indicated in individuals who have shown hypersensitivity to ofloxacin, any of its excipients or any other quinolones.
Special warnings and precautions for use
EXOCIN is not for injection. Safety and effectiveness in infants below the age of one year have not been established. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Drug interaction studies ...
Pregnancy and lactation
Use in pregnancy There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Transient blurring of vision may occur on instillation of eye drops. Do not drive or operate hazardous machinery ...
Undesirable effects
General Serious reactions after use of systemic ofloxacin are rare and most symptoms are reversible. Since a small amount of ofloxacin is systemically absorbed after topical administration, side-effects ...
Overdose
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, anti-infectives, fluoroquinolones ATC code: S01AE01 Ofloxacin is a synthetic fluorinated 4-quinolone antibacterial agent with activity against a broad spectrum ...
Pharmacokinetic properties
After ophthalmic instillation, ofloxacin is well maintained in the tear-film. In a healthy volunteer study, mean tear film concentrations of ofloxacin measured four hours after topical dosing (9.2µg/g) ...
Preclinical safety data
There are no toxicological safety issues with this product in man as the level of systemic absorption from topical ocular administration of ofloxacin is minimal. Animal studies in the dog have found cases ...
List of excipients
Benzalkonium chloride (EP) 0.005% w/v Sodium chloride (EP) 0.9% w/v Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Purified water (EP)
Incompatibilities
None known.
Shelf life
2 years unopened. Discard 28 days after first opening.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A bottle and an applicator tip of low density polyethylene (LDPE) and medium or high impact polystyrene cap. The bottle contains 5 ml or 10 ml of suspension. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
There is no special requirement for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Allergan Ltd, Marlow International, The Parkway, Marlow, Bucks SL7 1YL, United Kingdom
Marketing authorization number(s)
PL 00426/0070
Date of first authorization / renewal of the authorization
Date of first authorisation: 26th October 1992 Date of last renewal: 8th November 2004
Date of revision of the text
April 2016
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