Summary of Product Characteristics
last updated on the eMC:
11/09/2007
Go to top of the pageGo to top of the page | Dibrompropamidine isetionate 0.15% w/w. | |
Go to top of the pageGo to top of the pageGo to top of the page | Dibrompropamidine isetionate is an aromatic diamidine which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis. | |
Go to top of the page | Adults, elderly persons and children: for the treatment of minor eye infections.Apply topically once or twice daily. Medical advice should be obtained if there has been no significant improvement after two days. | |
Go to top of the page | Hypersensitivity to dibrompropamidine or any component of the preparation. | |
Go to top of the page | If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.If there is no significant improvement after two days' therapy, discontinue use and consult a physician.The eye ointment is unsuitable for use with hard or soft contact lenses. | |
Go to top of the pageGo to top of the page | Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician. | |
Go to top of the page | Eye ointment will cause blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear. | |
Go to top of the page | Hypersensitivity may occur, in which case treatment should be discontinued immediately. | |
Go to top of the page | Topical overdose not applicable. Oral ingestion of a full 5g tube is unlikely to cause any toxic effects. | |
Go to top of the pageGo to top of the page | Dibrompropamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli. The activity of the diamidines is retained in the presence of organic matter such as pus and blood. | |
Go to top of the pageGo to top of the pageGo to top of the pageGo to top of the page | Paraffin soft yellow, Paraffin liquid, Lanolin anhydrous, Phenylethanol,Water for injections. | |
Go to top of the pageGo to top of the page | 36 months. Use within 4 weeks of first opening | |
Go to top of the pageGo to top of the page | Printed, internally lacquered aluminium collapsible tubes with screw capped nozzle fitted with a polythene cap containing 5g ointment. | |
Go to top of the page | No relevant instructions. | |
Go to top of the page | sanofi-aventisOne Onslow StreetGuildfordSurreyGU1 4YS | |
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More information about this product
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