Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
INDOMETACIN
Laboratoires Chauvin
0.1 %w/v
Eye Drops Pdr & Solv for Soln
1996-07-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indocollyre 0.1%, eye drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted each 5ml contains 5mg of Indometacin, as a 0.1% w/v solution. For excipients, see 6.1 3 PHARMACEUTICAL FORM Eye drops, powder and solvent for solution. The appearance of the powder in the vial is white to cream-coloured. The solvent solution appears as a clear, colourless and viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of per-operative miosis during cataract surgery. Prevention of inflammatory manifestations related to surgical operations for cataract and to anterior segment of the eye. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION ADULTS - Prevention of per-operative miosis during cataract surgery, 1 drop every 30 minutes within 2 hours preceding the operation. - Prevention of inflammatory manifestations related to cataract and to anterior segment of the eye surgery. - 1 drop 4 to 6 times a day before operation, 1 drop every 30 minutes within 2 hours preceding the operation, and 1 drop 4 times per day for one month. - To administer treatment, gently pull down the lower lid of the eye and apply one drop of solution while looking upwards. CHILDREN Safety and efficacy of use in children has not been established. 4.3 CONTRAINDICATIONS This product is contra-indicated in the following situations: from the 6 th month of pregnancy onwards (see: Pregnancy and Breast-feeding), allergy to indomethacin or to drugs with similar activity e.g. other non-steroidal anti-inflammatory drugs or aspirin, allergy to the preservative (thiomersal), previous asthma attacks caused by aspirin or other non-steroidal anti-inflammatory drugs. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 09/11 Citiți documentul complet