MANUSEPT Cutaneous Solution 0.5/70 %w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

TRICLOSAN ISOPROPANOL

Available from:

Medlock Medical Ltd

Dosage:

0.5/70 %w/v

Pharmaceutical form:

Cutaneous Solution

Authorization date:

2006-10-20

Summary of Product characteristics

                                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
                                
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