Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Cetrimide; Chlorhexidine gluconate
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D08AJ; D08AJ04
Cetrimide; Chlorhexidine gluconate
2.25%w/v +0.225 percent weight/volume
Concentrate for cutaneous solution
Product not subject to medical prescription
Quaternary ammonium compounds; cetrimide
Not marketed
1991-06-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Savlon Antiseptic Liquid. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cetrimide 2.25 % w/v and Chlorhexidine Gluconate 0.225 % w/v. Excipients: also includes benzyl benzoate 0.056% w/v For a full list excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Concentrate for Cutaneous Solution. A clear, colourless or almost colourless liquid with a pine-like odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A topical antiseptic for prevention and management of infection or superficial skin trauma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. Two capfuls to ½ litre of warm water. 4.3 CONTRAINDICATIONS Hypersensitivity to chlorhexidine, cetrimide or to any of the excipients listed in Section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or condition worsens or if a skin reaction occurs, discontinue use and consult a doctor. For external use only. Avoid contact with the eyes, ears, mouth or other mucosa. If accidentally splashed into the eye, the open eye should be irrigated with water for at least 10 minutes. Savlon Antiseptic Liquid contains benzyl benzoate which may be mildly irritant to the skin, eyes and mucous membranes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed with the topical forms. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _5_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _ Lire le document complet