NEVANAC Eye drops, suspension Ref.[9458] Active ingredients: Nepafenac

Posology

Adults, including the elderly

For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.

For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.

Special populations

Patients with renal or hepatic impairment

NEVANAC has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.

Paediatric population

The safety and efficacy of NEVANAC in children and adolescents have not been established. No data are available. Its use is not recommended in these patients until further data become available.

Geriatric population

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Method of administration

For ocular use.

Patients should be instructed to shake the bottle well before use. After cap is removed, if tamper evident snap collar is loose, remove before using product.

If more than one topical ophthalmic medicinal product is being used, the medicinal product must be administered at least 5 minutes apart. Eye ointments should be administered last.

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. Patients should be instructed to keep the bottle tightly closed when not in use.

If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine. Do not use a double dose to make up for the 1 missed.

No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.

2 years.

Discard 4 weeks after first opening.

Do not store above 30°C.

For storage conditions after first opening of the medicinal product, see section 6.3.

5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension.

Carton containing 1 bottle.

No special requirements for disposal.