HIBITANE Cutaneous Solution Concentrate 5 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
CHLORHEXIDINE DIGLUCONATE (AS CHLORHEXIDINE DIGLUCONATE SOLUTION (20% W/V) PH.EUR.
Available from:
Regent Medical Overseas Limited
Dosage:
5 %w/v
Pharmaceutical form:
Cutaneous Solution Concentrate
Authorization date:
2005-02-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hibitane 5% w/v concentrate for cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 5% w/v (incorporated as Chlorhexidine Gluconate Solution).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for cutaneous solution
Clear red liquid with an odour of lavender.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hibitane 5% w/v Concentrate is an antimicrobial agent for general antiseptic purposes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
*
_sterilise the dilution by autoclaving at 115º – 116ºC for 30 minutes or 121º – 123ºC for 15 minutes_
4.3 CONTRAINDICATIONS
Hibitane preparations are contraindicated for patients who have previously shown a hypersensitivity reaction to
chlorhexidine. However, such reactions are extremely rare.
Use in contact with the brain, meninges, middle ear or eyes.
METHOD OF PREPARATION
CONCENTRATION OF ACTIVE INGREDIENT
REQUIRED (CHLORHEXIDINE
GLUCONATE)
USE
10ml made up to 1 litre
with water (1 in 100)
1 in 2,000 (0.05%) aqueous
Swabbing in obstetrics, wounds and burns*.
Storage of sterile instruments.
10ml with 15ml water
made up to 100ml with
95 % alcohol (1 in 10) (or
any multiple that gives 1
in 10)
1 in 200 (0.5 %) in 70 % alcohol
Preoperative skin disinfection.
Emergency instrument disinfection (2
minutes immersion) – (excluding
endoscopes containing cemented glass
components).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/06/2011_
_CRN 2097589_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Dilute before use.
Not for injection. Do not use in body cavities.
The concentrated solution is irritant t
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