1. Name Of The Medicinal Product
Hibisol 0.5% w/v Cutaneous Solution.
2. Qualitative And Quantitative Composition
Chlorhexidine gluconate solution 2.5% w/v (incorporated as Chlorhexidine gluconate solution 20%).
For excipients, see 6.1.
3. Pharmaceutical Form
Cutaneous solution. Clear, colourless, non-viscous solution having an odour of isopropyl alcohol.
4. Clinical Particulars
4.1 Therapeutic Indications
For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients' skin prior to surgery or other invasive procedures.
4.2 Posology And Method Of Administration
Route of administration: For external use only
Adults
Pre-operative surgical hand disinfection - Dispense 5ml of Hibisol and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5ml and repeat the procedure.
Antiseptic hand disinfection on the ward - Dispense 3ml of Hibisol and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients' skin - Prior to surgery apply Hibisol to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Hibisol is also used for preparation of the skin prior to invasive procedures such as venepuncture.
Elderly and children
There are no special dosing regimes for children and the elderly.
4.3 Contraindications
Hibisol is contraindicated for persons 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 only. Avoid contact with the brain, meninges or middle ear. Not for injection. Do not use in body cavities.
The solution is irritant to eyes and mucous membranes. Keep out of eyes. If chlorhexidine solutions come into contact with the eyes, wash out promptly and thoroughly with water.
Flammable – this preparation contains alcohol: when use is to be followed by diathermy do not allow pooling of the fluid to occur, and ensure that the skin and surrounding drapes are dry.
Prolonged skin contact with alcoholic solutions should be avoided, allow to dry before proceeding.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
See section 6.2.
4.6 Pregnancy And Lactation
No untoward effects are known.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare.
4.9 Overdose
Overdosage is very unlikely.
Accidental ingestion: chlorhexidine taken orally is poorly absorbed. Treat with gastric lavage using milk, raw egg, gelatin or mild soap avoiding pulmonary aspiration. Do not use apomorphine. Assist respiration if necessary and keep the patient warm. Intravenous laevulose can accelerate alcohol metabolism. In severe cases, haemodialysis or peritoneal dialysis may be necessary.
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
Cyclomethicone 5; isopropyl isostearate; isopropyl alcohol; purified water.
6.2 Incompatibilities
Chlorhexidine is incompatible with soap and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics, which have previously been in contact with preparations containing chlorhexidine.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Do not store above 25oC (flammable).
6.5 Nature And Contents Of Container
White HDPE bottle (500ml).
6.6 Special Precautions For Disposal And Other Handling
None.
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 21855/0003.
9. Date Of First Authorisation/Renewal Of The Authorisation
30th December 2004.
10. Date Of Revision Of The Text
February 2006.
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