País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE DIACETATE
Baxter Healthcare Limited
0.05 %w/v
Solution for Irrigation
1983-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0167/010/012A Case No: 2044438 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CHLORHEXIDINE ACETATE BP 0.05% IRRIGATION SOLUTION The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 01/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/07/2008_ _CRN 2044438_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorhexidine Acetate BP 0.05% w/v Irrigation solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Chlorhexidine Acetate QUANTITATIVE COMPOSITION Chlorhexidine Acetate Per litre: 0.5 g For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Irrigation solution. 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 Leer el documento completo