Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate; Cetrimide
Medlock Medical Ltd
D08AC52
Chlorhexidine gluconate; Cetrimide
0.015 %w/v + 0.15 percent volume/volume
Cutaneous solution
Product not subject to medical prescription
chlorhexidine, combinations
Marketed
1988-05-30
PANTONE Cool Gray 10 U PANTONE 361 U Profile Medlock Tisept Leaflet 327193-01 504000.209x144.004 Rachel Webb 12/02/15 MB XX XX XX XX X X X X X XX XX XX XX XX X X X X 209 x 144 01 MetalBack Ref Emboss Ref PANTONE Cool Gray 10 U PANTONE 361 U Profile Medlock Tisept Leaflet 327193-01 504000.209x144.004 Rachel Webb 12/02/15 MB XX XX XX XX X X X X X XX XX XX XX XX X X X X 209 x 144 01 MetalBack Ref Emboss Ref Læs hele dokumentet
Health Products Regulatory Authority 23 August 2019 CRN00919G Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sterets Tisept Sachets 0.015% w/v and 0.15% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 0.015 % w/v Cetrimide 0.15 % w/v For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A clear, yellow, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A broad spectrum antiseptic with detergent properties for swabbing in obstetrics and during dressing changes. For disinfecting and cleansing traumatic and surgical wounds and burns. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical application. Cleanse affected area or involved skin with undiluted preparation. 4.3 CONTRAINDICATIONS 1. Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8). 2. Use in contact with brain, meninges or middle ear. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sterets Tisept Sachets contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Sterets Tisept Sachets should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8). The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life. Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excess Læs hele dokumentet