Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
FRAMYCETIN SULFATE DEXAMETHASONE GRAMICIDIN
Roussel Laboratories Limited
0.5/0.05/0 %v/v
Ointment
1977-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sofradex Ear/Eye Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The ointment contains Framycetin Sulphate 5mg/g (0.5% w/w), Dexamethasone 0.5mg/g (0.05% w/w) and Gramicidin 0.05mg/g (0.005% w/w). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment. A clear to white, translucent, smooth homogenous sterile, greasy ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the eye: For the short-term treatment of steroid responsive conditions of the eye, when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease. In the ear: Otitis externa. Application to the eyelid: Blepharitis. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Route of administration: Topical ADULTS (AND THE ELDERLY) AND CHILDREN: In the eye: Apply sparingly two or three times daily, or at night if drop treatment is given during the day. In the ear: Apply once or twice daily. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredients. Use in the presence of infections of viral, treponemal, tuberculous or of non-sensitive fungal origin. Use in infants. The product should not be used if there is a perforation of the tympanic membrane, as entry into the middle ear could lead to ototoxicity. Use is contraindicated if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 24/08/2005_ _CRN 2014117_ _page number: 1_ 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged use of an anti-infective may Aqra d-dokument sħiħ