מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
FRAMYCETIN SULFATE
Roussel Laboratories Limited
FRAMYCETIN SULFATE
0.5 %w/w
Eye Ointment
Withdrawn
2007-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Soframycin Eye Ointment 5mg/g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Framycetin Sulphate 0.5% w/w (5mg/g) For excipents, see 6.1. 3 PHARMACEUTICAL FORM Eye Ointment A clear to white, translucent, smooth, homogenous, sterile, greasy eye ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of superficial bacterial infections of the eye due to micro-organisms sensitive to the anti- infective. Soframycin is used for the treatment of bacterial infections of the eye, notably conjunctivitis and blepharitis, for styes, corneal abrasions and burns, and prophylactically following the removal of foreign bodies. It is also indicated for corneal ulcers (alone or as a complement to the use of Soframycin by sub-conjunctival injection). 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Topical, into conjunctival sac. For continued effect, three applications of the ointment daily or at bedtime if drops have been used during the day. 4.3 CONTRAINDICATIONS Known hypersensitivity to framycetin or chemically related antibiotics or any of the other components in the preparation 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged use of an anti-infective may result in the development of superinfection due to micro-organisms, including fungi, resistant to that anti-infective. Aminoglycosides have been reported to cause irreversible partial or total deafness when given systemically, topically to open wounds or broken skin and intraperitoneally. These effects have not been reported with topical ocular administration of framycetin. However, the possibility should be considered when using high dose topical treatment in the elderly, small children or those patients with renal or hepatic impairment. In cases of severe infect קרא את המסמך השלם