1. Name Of The Medicinal Product
Sterets Tisept Sachets.
2. Qualitative And Quantitative Composition
Chlorhexidine Gluconate Solution 20% equivalent to Chlorhexidine Gluconate 0.015% w/v ; Cetrimide 0.15% w/v.
3. Pharmaceutical Form
Cutaneous solution
4. Clinical Particulars
4.1 Therapeutic Indications
A broad spectrum antiseptic with detergent properties for swabbing in obstetrics and during dressing changes. For disinfecting and cleansing traumatic and surgical wounds and burns.
4.2 Posology And Method Of Administration
Use without further dilution. For topical administration only.
4.3 Contraindications
Sterets Tisept should not come into contact with the brain, eyes, meninges or middle ear and is contraindicated for persons who have previously shown a hypersensitivity to chlorhexidine.
4.4 Special Warnings And Precautions For Use
For external use only. Not for injection. When used in aseptic procedures, the outside of the sachet should be disinfected before opening. Discard any surplus immediately after use. 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 that have previously been in contact with Sterets Tisept 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 allergenic reactions to chlorhexidine can occur, but these are rare.
4.9 Overdose
Treatment of accidental ingestion: Gastric lavage should be carried out with milk, egg white, gelatin 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. Cetrimide is a quaternary ammonium disinfectant with properties and uses typical of cationic surfactants. It is used in Sterets Tisept for its surfactant and bactericidal properties.
5.2 Pharmacokinetic Properties
The British Pharmacopoeia 1993 contains monographs for both Chlorhexidine Gluconate solution 20% w/v and Cetrimide. The pharmacokinetics of the compounds when applied to the skin are well described in the literature.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sunset Yellow E110; Sodium hydroxide; purified water.
6.2 Incompatibilities
Sterets Tisept is incompatible with anionic agents.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Store in a cool, dark place. Store sachets in outer container.
6.5 Nature And Contents Of Container
Nylon/ethylene propylene copolymer laminate sachets containing either 25 or 100ml 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 Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 21248/0035.
9. Date Of First Authorisation/Renewal Of The Authorisation
19th April 2006.
10. Date Of Revision Of The Text
April 2006.
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