Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Cetrimide; Chlorhexidine gluconate
Clonmel Healthcare Ltd
D08AJ; D08AJ04
Cetrimide; Chlorhexidine gluconate
0.5/0.1 percent weight/weight
Cream
Quaternary ammonium compounds; cetrimide
Marketed
1991-06-26
Health Products Regulatory Authority 04 November 2019 CRN0098VW Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Savlon Antiseptic Cream Cetrimide 0.5% w/w Chlorhexidine Digluconate 0.1% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: Cetrimide 0.50% w/w Chlorhexidine digluconate 0.10% w/w Excipients: Cetostearyl alcohol 10.00% w/w Methyl parahydroxybenzoate (E218) 0.01% w/w Propyl parahydroxybenzoate (E216) 0.01% w/w For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream. Smooth, white, homogenous cream with an antiseptic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For prevention and management of superficial infections in skin tissue including wounds and minor burns. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. Apply the cream over the affected area after cleansing. 4.3 CONTRAINDICATIONS Hypersensitivity to chlorhexidine digluconate, cetrimide or to any of the excipient listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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 for at least 10 minutes. If symptoms persist or condition worsens, discontinue use and consult a physician. The product is incompatible with anionic substances (e.g. soap). Information concerning excipients Savlon cream contains: - Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) - Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). Health Products Regulatory Authority 04 November 2019 CRN0098VW Page 2 of 4 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy: There are no adequate data from the use of chlorhexidine digluconate and cetrimide in pregnant women. The potential risk for humans is unknown but is most Прочетете целия документ