Sterets H Pre-Injection Swabs (Molnlycke Health Care )

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 24^oC. 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

3^rd February 2006.

10. Date Of Revision Of The Text

February 2006.