Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE GLUCONATE CETRIMONIUM BROMIDE
Regent Medical Overseas Limited
1.5, 15.0 %w/v
Cutaneous Solution Concentrate
2005-09-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1218/004/001 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 HIBICET HOSPITAL CONCENTRATE FOR 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. 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 Hibicet Hospital Concentrate for cutaneous solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine gluconate 1.5% w/v (equivalent to 7.5% v/v chlorhexidine gluconate 20% solution) Cetrimide 15% w/v (equivalent to 37.5%w/v strong cetrimide solution 40%w/v) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Concentrate for cutaneous solution. A clear, deep orange perfumed aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 'Hibicet' Hospital Concentrate is an antimicrobial preparation with cleansing properties for general a Leggi il documento completo