Страна: Израиль
Язык: английский
Источник: Ministry of Health
SODIUM FUSIDATE
DEXCEL LTD, ISRAEL
D06AX
OINTMENT
SODIUM FUSIDATE 20 MG/G
DERMAL
Required
LEO LABORATORIES LTD., IRELAND
OTHER ANTIBIOTICS FOR TOPICAL USE
Local treatment of skin infections due to sensitive strains of staphylococcuos aureus
2022-03-31
FUCIDIN CREAM FUCIDIN OINTMENT SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fucidin cream Fucidin ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fucidin cream Each gram of cream contains 20 mg fusidic acid. Excipients with known effect: Contains Butylhydroxyanisole 0.04 mg/g, Potassium Sorbate 2.7 mg/g and cetyl alcohol 111 mg/g. For a full list of excipients, see section 6.1. Fucidin ointment Each gram of ointment contains: 20 mg sodium fusidate. Excipients with known effect: Contains cetyl alcohol 4 mg/g, wool fat (lanolin) 46 mg/g and butylhydroxytoluene For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Fucidin cream Cream A white cream. Fucidin ointment Ointment Translucent, yellowish to white ointment 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local treatment of skin infections due to sensitive strains of staphylococcus aureus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply three to four times daily or as required. Less frequent application may be adequate for covered lesions. Method of administration Cutaneous use 4.3 CONTRAINDICATIONS Known hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients listed in section 6.1. 4.4 SPECIALS WARNINGS AND PRECAUTIONS FOR USE 1 Bacterial resistance among _Staphylococcus aureus_ has been reported to occur with the use of topical Fucidin ® . As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Fucidin cream Fucidin cream contains butylhydroxyanisole, potassium sorbate and cetyl alcohol. These excipients may cause local skin reactions (e.g. contact dermatitis). In addition, butylhydroxyanisole may also cause irritation to the eyes and the mucous membranes. Fucidin ® Cream should therefore be used with care when applied in the proximity of the eyes. _ _ Fucidin ointment Fucidin ® ointment contains cetyl alcohol and wool fat (lanolin). These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidi Прочитать полный документ