Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
TRICLOSAN ISOPROPANOL
Medlock Medical Ltd
0.5/70 %w/v
Cutaneous Solution
2006-10-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1175/005/001 Case No: 2032104 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDLOCK MEDICAL LTD TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product MANUSEPT ANTIBACTERIAL HAND RUB 0.5%W/V + 70%V/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 23/04/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/09/2007_ _CRN 2032104_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Manusept Antibacterial Hand Rub 0.5% w/v + 70% v/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 5mg Triclosan Each ml contains 0.7ml Isopropyl Alcohol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A clear, colourless cutaneous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For skin disinfection prior to surgery, injection and venepuncture. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical. Hand disinfection: Apply 3ml to washed hands. Rub vigorously into hands until dry. Pre-operative hand disinfectio Baca dokumen lengkapnya