Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE DIACETATE
Baxter Healthcare Limited
CHLORHEXIDINE DIACETATE
0.02 %w/v
Solution for Irrigation
Withdrawn
2008-03-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorhexidine Acetate BP 0.02% w/v Irrigation solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Chlorhexidine Acetate. QUANTITATIVE COMPOSITION Per litre: Chlorhexidine Acetate 0.2 g For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Irrigation solution. A clear, colourless, sterile aqueous irrigation solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a disinfectant for topical irrigation of wounds and burns. For disinfection of respirators. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage_ The dosage of the product is determined by the individual patient’s requirements. _Administration_ For topical use only. 4.3 CONTRAINDICATIONS This solution should not come into contact with the brain meninges, perforated ear drum or eyes. This solution is not recommended for bladder-irrigation. Use in patients with known hypersensitivity to chlorhexidine. This solution is not for use in abdominal cavities, unless under supervision of a specialist. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/11/2007_ _CRN 2043475_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This solution should not be taken orally. This solution is not for intravenous administration. Accidental ingestion should be treated with a stomach lavage consisting of milk, egg white, gelatine or mild soap. Idiosyncratic reactions to chlorhexidine acetate BP have been reported. This product should only be used in specialist units familiar with the appropriate selection of patients. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The action of chlorhexidine is reduced by an alkaline pH, the presence of Lugege kogu dokumenti