TRAVATAN Eye drops, solution Ref.[8289] Active ingredients: Travoprost

Posology

Use in adults, including elderly population

The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

When substituting another ophthalmic antiglaucoma medicinal product with TRAVATAN, the other medicinal product should be discontinued and TRAVATAN should be started the following day.

Hepatic and renal impairment

TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dosage adjustment is necessary in these patients (see section 5.2).

Paediatric population

TRAVATAN can be used in paediatric patients from 2 months to <18 years at the same posology as in adults. However, data in the age group 2 months to <3 years (9 patients) is limited (see section 5.1).

The safety and efficacy of TRAVATAN in children below the age of 2 months have not been established. No data are available.

Method of Administration

For ocular use.

For patients who wear contact lenses, please refer to section 4.4.

The patient should remove the protective overwrap immediately prior to initial use. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

No cases of overdose have been reported. A topical overdose is not likely to occur or to be associated with toxicity. A topical overdose of TRAVATAN may be flushed from the eye(s) with lukewarm water. Treatment of a suspected oral ingestion is symptomatic and supportive.

Shelf life: 2 years.

Discard 4 weeks after first opening.

This medicinal product does not require any special storage conditions.

4 mL oval Polypropylene (PP) or Low Density Polyethylene (LDPE) bottle and PP or LDPE dispensing plug with a PP screw cap, presented in an overwrap. Each 4 mL bottle will contain 2.5 mL of solution.

Cartons containing 1 or 3 bottles.

Not all pack sizes may be marketed.

No special requirements.