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Active Element: Levofloxacin 5 mg/ml

Dosage Form:

Composition

Levofloxacin (as Levofloxacin hemihydrate) 5 mg/ml

Dosage Form

Eye drops solution

Indication

Topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms

Dosage Adminstration

Posology

For all patients instil one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5.

If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.

The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days.

Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established.

Use in the Elderly

No adjustment of dosage is required.

Paediatric population

The posology is the same in adults and children aged ≥1 year.

The safety and efficacy of Levofloxacin in children aged ≥1 year have been established.

Levofloxacin is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.

The safety and efficacy of Levofloxacin in children aged < 1 year have not yet been established.

No data are available.

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