1. Name Of The Medicinal Product
Hibitane 5% Concentrate.
2. Qualitative And Quantitative Composition
Chlorhexidine gluconate 5.0% w/v (incorporated as Chlorhexidine Gluconate Solution Ph.Eur.).
3. Pharmaceutical Form
Liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
Hibitane 5% Concentrate is an antimicrobial agent for general antiseptic purposes. A surface active agent is present to inhibit precipitation when dilutions are made with hard water.
4.2 Posology And Method Of Administration
For external (topical) use only. No special dosages or indications are specified for use of this product for children or the elderly.
Dilute before use with fresh distilled water, tap water of an acceptable bacteriological standard or alcohol (ethanol, industrial methylated spirit or isopropanol).
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* 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.
4.4 Special Warnings And Precautions For Use
For external use. Dilute before use. Solutions applied to wounds, burns or broken skin should be sterile. Syringes, needles or instruments which have been immersed in Hibitane solutions should be thoroughly rinsed in sterile water or saline before use. Avoid contact with the brain, meninges and middle ear. Not for injection. Do not use in body cavities. The concentrated solution is irritant to eyes and mucous membranes. Keep all solutions out of the eyes. If chlorhexidine solutions come into contact with the eyes, rinse promptly and thoroughly with water. Prolonged skin contact with alcoholic solutions should be avoided. Allow to dry before proceeding.
As with any other antiseptic agent, antimicrobial activity may be diminished through incompatibility or in the presence of significant quantities of organic matter.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Hibitane 5% Concentrate contains a surfactant and therefore instruments containing cemented glass components should not be disinfected with solutions prepared from Hibitane 5% concentrate.
The low solubility of inorganic salts of chlorhexidine may cause precipitation and consequent loss of activity if Hibitane 5% concentrate is diluted with a solution containing inorganic anions, for example saline or peritoneal dialysis fluid. This precipitation may occur when Hibitane 5% concentrate is used to disinfect catheters intended for use in peritoneal dialysis. Inadvertent repeated exposure of peritoneal membranes to precipitated material has been claimed as a possible predisposing factor for peritoneal fibrosis.
4.6 Pregnancy And Lactation
There is no evidence of any adverse effects from the use of Hibitane 5% Concentrate during pregnancy and lactation therefore no special precautions are recommended.
4.7 Effects On Ability To Drive And Use Machines
None have been reported or are known.
4.8 Undesirable Effects
Irritative skin reactions can occasionally occur. Generalised allergic reactions to chlorhexidine have also been reported but are extremely rare.
4.9 Overdose
This has not been reported.
Accidental ingestion:
Chlorhexidine taken orally is poorly absorbed. Treat with gastric lavage with milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.
Accidental intravenous infusion:
Blood transfusion may be necessary to counteract haemolysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Chlorhexidine is effective against a wide range of gram-negative and gram-positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is inactive against bacterial spores except at elevated temperatures.
5.2 Pharmacokinetic Properties
Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.
5.3 Preclinical Safety Data
Chlorhexidine is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Carmoisine E122; d-gluconolactone; isopropyl alcohol; linalyl acetate; nonylphenol/ethylene oxide condensate; purified water.
6.2 Incompatibilities
Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine. Chlorhexidine is incompatible with soap and other anionic agents.
6.3 Shelf Life
4 years.
6.4 Special Precautions For Storage
Do not store above 30ºC.
6.5 Nature And Contents Of Container
White HDPE bottle with tamper evident HDPE screw cap (5 litres)
6.6 Special Precautions For Disposal And Other Handling
As cork may protect certain gram-negative organisms from the action of antiseptics, Hibitane solutions must be stored in bottles with glass, plastic or rubber closures.
As a precaution against bacterial contamination, aqueous stock solutions should contain at least 4% v/v of isopropanol or 7% v/v of ethanol which may be denatured (ie industrial methylated spirit).
Aqueous dilutions of Hibitane used for instrument storage should contain 0.1% w/v sodium nitrite to inhibit metal corrosion. Such solutions must be changed every 7 days.
See also section 4.4.
7. Marketing Authorisation Holder
Regent Medical Overseas Limited, Two Omega Drive, River Bend Technology Centre, Irlam, Manchester, M44 5BJ, United Kingdom.
8. Marketing Authorisation Number(S)
PL 21855/0004.
9. Date Of First Authorisation/Renewal Of The Authorisation
30th December 2004.
10. Date Of Revision Of The Text
December 2004.
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