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EXOCIN Eye drops, solution (2016)

Αναφορές

Βιβλιογραφική αναφορά

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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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