Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Triclosan
Ayrton Saunders Ltd
D08AE; D08AE04
Triclosan
20 milligram(s)/millilitre
Cutaneous solution
Product not subject to medical prescription
Phenol and derivatives; triclosan
Not marketed
1992-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aquasept Skin Cleanser 20mg/ml Cutaneous Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 20mg Triclosan Excipients: also contains chlorocresol 0.25% w/v, and Propylene glycol 5% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A clear blue aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This product has an antibacterial effect and is intended for the following uses: For skin disinfection prior to surgery and for routine skin cleansing to reduce the risk of cross-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For pre-operative hand disinfection (100ml, 250ml, 500ml, 5l): Wet area to be cleansed. Apply about 5ml of Aquasept and wash for one minute, paying particular attention to the area around the fingernails and cuticles and between the fingers. Rinse and repeat for two minutes. Rinse thoroughly and dry hands with a sterile towel. Antiseptic skin cleanser (100ml, 250ml, 500ml, 5l): Wet area to be cleansed and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly. 4.3 CONTRAINDICATIONS Hypersensitivity to triclosan or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Avoid contact with eyes or mucous membranes. Keep out of reach of children. Do not apply to broken skin. Some product excipients may give rise to allergic reactions in some people. In this instance, discontinue use and seek medical advice. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Citiți documentul complet