Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NEPAFENAC
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
NEPAFENAC
5 ml
ALCON COUVREUR N.V
_Customer Medication Indication Leaflet (RiMUP) _ NEVANAC OPHTHALMIC SUSPENSION Nepafenac 0.1% w/v 1 WHAT IS IN THIS LEAFLET 1. What Nevanac is used for 2. How Nevanac works 3. Before you use Nevanac 4. How to use Nevanac 5. While you are using it 6. Side effects 7. Storage and Disposal of Nevanac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NEVANAC IS USED FOR Nevanac contains the active substance nepafenac, and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Nevanac is indicated for the treatment of pain and inflammation associated with cataract surgery. Reduction in the risk of after operation macular oedema (swelling in the macula, the central part of the retina at the back of the eye) associated with cataract surgery in diabetic patients. HOW NEVANAC WORKS Nevanac reduces pain and inflammation associated with cataract surgery. BEFORE YOU USE NEVANAC - _When you must not use it _ Do not use Nevanac • if you are allergic to nepafenac or any of the other ingredients of this medicine • if you are allergic to non- steroidal anti- inflammatories (NSAIDs). • if you have experienced asthma, skin allergy, or intense inflammation in your nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac. - _Before you start use it _ Talk to your doctor, pharmacist or nurse before using Nevanac if you have the following condition: 1. bleeding tendency 2. eye disorder 3. eye infection 4. diabetes 5. rheumatoid arthritis 6. eye surgery Avoid sunlight during treatment with Nevanac. Wearing contact lenses is not recommended after cataract surgery. Your doctor will advise you when you can use contact lenses again. _Pregnancy and breast-feeding _ If you are pregnant, or might get pregnant, talk to your doctor before you use Nevanac. Women who may become pregnant are advised to use effective contraception during Nevanac treatment. The use of Nevanac is not recommended during pre Lestu allt skjalið
Novartis Malaysia Package Insert 19-Nov-2020 Nevanac ® 1. NAME OF THE MEDICINAL PRODUCT NEVANAC 1 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains 1 mg nepafenac. Excipient with known effect Each ml of suspension contains 0.05 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension Light yellow to light orange uniform suspension, pH 7.4 (approximately). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEVANAC ® ophthalmic suspension is indicated for the treatment of 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) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Recommended Dose and Dosage Adjustment _ Shake well before use. One drop of NEVANAC ® ophthalmic suspension should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. 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 Novartis Malaysia Package Insert 19-Nov-2020 Nevanac ® 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 adolesce Lestu allt skjalið