País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
BENZALKONIUM CHLORIDE CETRIMONIUM BROMIDE
Chefaro Ireland Limited
0.01/0.2 %w/w
Cream
2005-01-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Drapolene Cream Benzalkonium chloride 0.01% w/w Cetrimide 0.2% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DRAPOLENE Cream contains benzalkonium chloride 0.01% w/w (as benzalkonium chloride solution 0.02% w/w) and Cetrimide 0.2% w/w. For a full list of excipient, see section 6.1 3 PHARMACEUTICAL FORM Cream A smooth homogenous pink water miscible cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DRAPOLENE Cream is indicated for the prevention and treatment of urinary ammonia dermatitis, particularly nappy rash, and in the treatment of minor burns and wounds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Children: _Nappy rash. For topical application. To be applied evenly at each nappy change, particular attention being paid to the folds of the skin. _Adults: _Urinary Dermatitis. Regular routine application is advised. _Use in the Elderly: _No special comment. Minor burns and wounds: Apply as required. Before applying Drapolene Cream, the affected area should be dry and free from all traces of soap. 4.3 CONTRAINDICATIONS DRAPOLENE Cream is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 6.1). Excipient(s) Wool Fat (purified lanolin) 2.0 % w/w Cetyl Alcohol 5.0 % w/w Cetostearyl alcohol 4.0 % w/w Chlorocresol 0.1 % w/w Amaranth (E123) 0.002 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/11/2011_ _CRN 2107998_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE DRAPOLENE Cream is for external use only. Drapolene Cream contains wool fat (purified lanolin), cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact der Leia o documento completo