Kraj: Unia Europejska
Język: angielski
Źródło: myHealthbox
Nepafenac
Alcon Laboratories (UK) Ltd.
S01BC10
Nepafenac
3mg/1 ml
Eye drops, suspension
Ocular use
3 ml plastic bottle (round or oval)
Subject to medical prescription
S.A. Alcon–Couvreur N.V
Ophthalmologicals, anti-inflammatory agents, non-steroids
Ophthalmologic Surgical Procedures, Postoperative Pain
Prevention and treatment of postoperative pain and inflammation associated with cataract surgery
Authorized
2013-05-03
37 PACKAGE LEAFLET: INFORMATION FOR THE USER NEVANAC 3 MG/ML EYE DROPS, SUSPENSION Nepafenac READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NEVANAC is and what it is used for 2. What you need to know before you use NEVANAC 3. How to use NEVANAC 4. Possible side effects 5. How to store NEVANAC 6. Contents of the pack and other information 1. WHAT NEVANAC IS AND WHAT IT IS USED FOR NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). NEVANAC 3 mg/ml eye drops, suspension is to be used by adults to prevent and relieve eye pain and inflammation following cataract surgery on the eye. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEVANAC DO NOT USE NEVANAC - if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to other nonsteroidal anti-inflammatory drugs (NSAID) - 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. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Przeczytaj cały dokument
10 1. NAME OF THE MEDICINAL PRODUCT NEVANAC 3 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains 3 mg nepafenac. Excipient(s) with known effect: Each ml of suspension contains 0.05 mg benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension (eye drops). Light yellow to dark orange uniform suspension, pH 6.8 (approximately). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEVANAC 3 mg/ml eye drops, suspension is indicated in adults for: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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) once a day beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 21 days of the postoperative period, as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery. In clinical trials, patients were treated for up to 21 days with NEVANAC 3 mg/ml eye drops, suspension (see section 5.1). Once-daily dosing with NEVANAC 3 mg/ml eye drops, suspension provides the same total daily dose of nepafenac as three-times-daily dosing with NEVANAC 1 mg/ml eye drops, suspension. 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 Przeczytaj cały dokument