1. Name Of The Medicinal Product
Sterets Unisept.
2. Qualitative And Quantitative Composition
Chlorhexidine Gluconate Solution 20% w/v BP 0.05% w/v.
3. Pharmaceutical Form
Sterile aqueous solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Chlorhexidine gluconate is a potent antibacterial agent for general antiseptic purposes. It is bactericidal to a broad spectrum of organisms. Sterets Unisept is recommended for use in obstetrics and for swabbing burns and wounds.
4.2 Posology And Method Of Administration
There is no distinction between adults, the elderly and children. Sterets Unisept should be used without further dilution for topical administration only.
4.3 Contraindications
Sterets Unisept should not come into contact with the brain, eyes, meninges or middle ear. The use of Sterets Unisept is also contraindicated in patients who have shown hypersensitivity to chlorhexidine.
4.4 Special Warnings And Precautions For Use
For external use only. Not for injection. When Sterets Unisept is used in aseptic procedures, the outside of the sachet should be disinfected before opening. Discard any surplus immediately after use. Contact with eyes should be avoided. Do not use within body cavities.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with Sterets Unisept solution.
4.6 Pregnancy And Lactation
Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Idiosyncratic skin reactions and generalised allergic reactions to chlorhexidine can occur, but these are rare.
4.9 Overdose
Treatment: Accidental ingestion - gastric lavage should be carried out with milk, egg white, gelatine or mild soap.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Chlorhexidine is a disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria: it is more effective against Gram-positive than Gram-negative bacteria, some species of Pseudomonas and Proteus being less susceptible. The wide range of organisms against which chlorhexidine is active explains the rationale for presenting it in a solution for swabbing wounds and burns and in obstetrics.
5.2 Pharmacokinetic Properties
The British Pharmacopoeia 1993 contains a monograph for Chlorhexidine Gluconate Solution 20% w/v. The pharmacokinetics of the compound when applied to the skin as a topical antiseptic are well understood and described in the literature.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Nonoxynol 10; sodium hydroxide; Carmoisine Red E122; purified water.
6.2 Incompatibilities
Sterets Unisept is incompatible with anionic agents.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store in a cool dark place. Store sachets in the outer containers.
6.5 Nature And Contents Of Container
Nylon-ethylene-propylene copolymer laminate sachets containing either 25 ml or 100 ml of product overwrapped in heat sealed polythene/nylon and / or polythene/polyester pouches.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL: 21248/0037.
9. Date Of First Authorisation/Renewal Of The Authorisation
10th April 2006.
10. Date Of Revision Of The Text
April 2006.
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