Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland
Oftaquix 5 mg/ml eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms (see also sections 4.4 and 5.1).
Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Oftaquix is indicated in adults, children aged ≥1 year to 12 years and adolescents aged 12 to 18 years.
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.
To prevent contaminating the dropper tip and solution, the dropper tip should not come into contact with the eyelids or surrounding areas.
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.
Oftaquix is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.
No adjustment of dosage is required.
The posology is the same in adults and children aged ≥1 year.
The safety and efficacy of Oftaquix in children aged ≥1 year have been established.
The safety and efficacy of Oftaquix in children <1 year have not yet been established. No data are available.
Ocular use.
The total amount of levofloxacin in a bottle of eye drops is too small to induce toxic effects after an accidental oral intake. If considered necessary, the patient can be observed clinically and supportive measures can be undertaken. After a local overdose with Oftaquix 5 mg/ml eye drops, the eyes can be flushed with clean (tap) water at room temperature.
Actions to be taken in case of overdose are the same in adults and in children aged ≥1 year.
3 years.
After first opening: to be used within 28 days.
This medicinal product does not require any special storage conditions.
Keep the container tightly closed.
5 ml of solution is supplied in a 5 ml white low-density polyethylene (LDPE) bottle with a LDPE dropper tip and a tan high-density polyethylene (HDPE) screw cap.
Pack size: 1 × 5 ml.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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