Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Nepafenac 3 mg/mL
Novartis New Zealand Ltd
Nepafenac 3 mg/mL
0.3 %
Eye drops, suspension
Active: Nepafenac 3 mg/mL Excipient: Benzalkonium chloride Boric acid Carbomer 974 Carmellose sodium Disodium edetate Guar gum Hydrochloric acid Propylene glycol Purified water Sodium chloride Sodium hydroxide
Prescription
Carbogen Amcis AG
Ilevro is indicated for the prevention and treatment of postoperative pain and inflammation associated with cataract surgery.
Package - Contents - Shelf Life: Bottle, dropper, 4 mL opaque, oval, LDPE container with PP closure w/ optional foil overwrap - 3 mL - 18 months from date of manufacture stored at or below 25°C protect from light 28 days opened stored at or below 25°C protect from light
2014-11-10
1 CONSUMER MEDICINE INFORMATION ILEVRO® EYE DROPS SUSPENSION 0.3% NEPAFENAC ONCE DAILY WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE ILEVRO EYE DROPS. This leaflet answers some common questions about Ilevro Eye Drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM www.medsafe.govt.nz. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using Ilevro against the expected benefits it will have for you. The information in this leaflet applies to Ilevro Eye Drops only. This information does not apply to similar products, even if they contain the same ingredients. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ILEVRO IS USED FOR Ilevro is used to prevent and treat pain and inflammation of the eye associated with cataract surgery. Ilevro contains the active substance nepafenac. It belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain and reduce inflammation (e.g. swelling, redness and throbbing). Your doctor may have prescribed Ilevro for another reason. Ask your doctor if you have any questions about why Ilevro has been prescribed for you. There is no evidence that Ilevro is addictive. _ _ 2 _USE IN CHILDREN _ Ilevro Eye Drops are not recommended in children and young adults aged under the age of 18 years as the safety and efficacy in children has not been established. _USE IN PREGNANCY AND IN BREASTFEEDING _ Perskaitykite visą dokumentą
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ILEVRO ® nepafenac 0.3% Eye Drops Suspension Once Daily 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ilevro Eye Drops contains nepafenac 3 mg in 1mL Excipient with known effect Benzalkonium chloride 0.05 mg in 1 mL as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. pH approximately 6.8. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ilevro is indicated for the prevention and treatment of postoperative pain and inflammation associated with cataract surgery. 4.2. DOSE AND METHOD OF ADMINISTRATION For ophthalmic use only. For individual patient use only. Shake the bottle well before use. After cap is removed, if tamper evident snap collar is loose, remove before using Ilevro. If more than one topical ophthalmic medicinal product is being used, the medicinal products 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. Instruct patients to keep the bottle tightly closed when not in use. For the prevention and treatment of pain and inflammation, the dose is 1 drop of Ilevro in the conjunctival sac of the affected eye(s) once a day beginning 1 day prior to cataract surgery and continued on the day of surgery. In clinical studies, the effectiveness of Ilevro was demonstrated for up to 14 days of the postoperative period. Treatment durations greater than two weeks and a dosing frequency of more than once daily have not been assessed. An additional drop should be administered 30 to 120 minutes prior to surgery. Nasolacrimal occlusion and gently closing the eyelid after instillation are recommended. This may reduce the systemic absorption of eye drops and result in a decrease in systemic adverse reactions. If a dose is missed, one drop should be administered as soon as possible before reverting to the regu Perskaitykite visą dokumentą