Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
CLINDAMYCIN PHOSPHATE
Pharmacia Ireland
10 Base mg/ml
Cutaneous Emulsion
2001-01-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of emulsion contains clindamycin phosphate equivalent to 10 mg clindamycin. Excipients: Cetostearyl alcohol 25 mg/ml Methyl parahydroxybenzoate (E218) 3 mg/ml For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous emulsion. Smooth, white to off-white emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a thin film of Dalacin T Topical Lotion twice daily to the affected area. 4.3 CONTRAINDICATIONS Dalacin T is contraindicated in patients previously found to be hypersensitive to preparations containing clindamycin or lincomycin. This is also contra-indicated in patients with a history of inflammatory bowel disease or a history of antibiotic-associated colitis. Dalacin T should not be used in patients with systemic infections for which antimicrobials are being used. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. However, post-marketing studies have indicated a very low incidence of colitis with Dalacin T Lotion. The physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or colitis. If diarrhoea occurs, the product should be discontinued immediately. Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic- associated colitis. Colitis is usually characterized by persistent, severe diarrhoea and abdominal cramps. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for C. difficile and/or assay for Olvassa el a teljes dokumentumot