HIBICET HOSPITAL CONCENTRATE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-04-2024
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Active ingredient:
CHLORHEXIDINE GLUCONATE CETRIMONIUM BROMIDE
Available from:
Regent Medical Overseas Limited
Dosage:
1.5, 15.0 %w/v
Pharmaceutical form:
Cutaneous Solution Concentrate
Authorization date:
2005-09-23
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)
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
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