NEVANAC® EYE DROPS SUSPENSION 1 MG/ML [SIN13759P]

Product Info

NEVANAC® EYE DROPS SUSPENSION 1 MG/ML

[SIN13759P]

4.1 Therapeutic indications

Nevanac is indicated in adults for:

• Prevention and treatment of postoperative pain and inflammation associated with cataract surgery.

• Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Use in adults, including the elderly
For the prevention and treatment of postoperative pain and inflammation associated with cataract surgery, the dose is one drop of NEVANAC eye drops 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. 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 eye drops 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.

Paediatric patients
The safety and efficacy of Nevanac in paediatric patients have not been established. Its use is not recommended in this age group until further data become available. There is no relevant use of NEVANAC eye drops in the paediatric population in the indications.

Use in hepatic and renal impairment
NEVANAC eye drops 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.

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

Method of administration

• For ocular use.

• After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product.

• Instruct patients to shake the bottle well before use.

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

• If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine. No double dose should be used to make up for the one missed.

• To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye. Patients should be instructed to keep the bottle tightly closed when not in use.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients, or to other nonsteroidal anti-inflammatory drugs (NSAIDs).
Like other NSAIDs, NEVANAC eye drops is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.