1. Name Of The Medicinal Product
Sterets H Pre-Injection Swabs.
2. Qualitative And Quantitative Composition
Isopropyl Alcohol BP 70% v/v; Chlorhexidine Acetate BP 0.5% w/v.
3. Pharmaceutical Form
Sachets containing viscose swab impregnated with isopropyl alcohol and chlorhexidine acetate.
4. Clinical Particulars
4.1 Therapeutic Indications
To be used for pre-injection site cleansing.
4.2 Posology And Method Of Administration
Topical. There are no differences in use between adults, the elderly and children. Use the wipe to cleanse the injection site.
4.3 Contraindications
None stated.
4.4 Special Warnings And Precautions For Use
Avoid contact with eyes or broken skin.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Alcohol should not be brought into contact with some vaccines and skin test injections (patch tests). If in doubt, consult the vaccine manufacturers' literature.
4.6 Pregnancy And Lactation
No special precautions required.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Normally without side effects although minor skin reactions have been attributed to chlorhexidine and to isopropyl alcohol (infrequent, minor).
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Isopropyl alcohol has disinfectant properties. Chlorhexidine is a disinfectant that is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria. A 0.5% solution of chlorhexidine acetate in 70% isopropyl alcohol is used for pre-operative disinfection of the skin. The solution is appropriate for swabbing on to cleanse and lower the skin bacteriological count prior to injections.
5.2 Pharmacokinetic Properties
There is little absorption of isopropyl alcohol through intact skin. Chlorhexidine acetate is adsorbed on to the skin surface but there is minimal further absorption. Pharmacokinetic particulars are not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
60 months unopened.
6.4 Special Precautions For Storage
Store in a cool dry place, away from direct sunlight. Flammable contents. Flash point 24oC. Product/contents should be kept away from a naked flame.
6.5 Nature And Contents Of Container
100 sachets per box. Printed aluminium foil laminated sachets (laminates of coated paper/polyethylene/aluminium foil/surlyn, the surlyn layer innermost).
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS, UK.
8. Marketing Authorisation Number(S)
21248/0026.
9. Date Of First Authorisation/Renewal Of The Authorisation
3rd February 2006.
10. Date Of Revision Of The Text
February 2006.
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