País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE DIGLUCONATE (AS CHLORHEXIDINE DIGLUCONATE SOLUTION (20% W/V) PH.EUR.
Regent Medical Overseas Limited
CHLORHEXIDINE DIGLUCONATE (AS CHLORHEXIDINE DIGLUCONATE SOLUTION (20% W/V) PH.EUR.
0.5% %v/v
Cutaneous Solution
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1218/002/001 Case No: 2068374 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to REGENT MEDICAL OVERSEAS LIMITED TWO OMEGA DRIVE, RIVER BEND TECHNOLOGY CENTRE, IRLAM, MANCHESTER M44 5BJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product HIBISOL 0.5% W/V CUTANEOUS 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 30/10/2009 until 29/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/10/2009_ _CRN 2068374_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hibisol 0.5% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 0.5% w/v (incorporated as Chlorhexidine Gluconate Solution) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. Clear, colourless, non-viscous solution having an odour of isopropyl alcohol 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 'Hibisol' is a rapid acting antimicrobial preparation for the disinfection of clean intact skin. It is used for pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedure Llegiu el document complet