Sterets Pre-Injection Swabs (Molnlycke Health Care )

1. Name Of The Medicinal Product

Sterets Pre-injection Swabs.

2. Qualitative And Quantitative Composition

Isopropyl Alcohol BP 70% v/v.

3. Pharmaceutical Form

Sachets containing viscose swab impregnated with isopropyl alcohol.

4. Clinical Particulars

4.1 Therapeutic Indications

To be used for pre-injection site cleansing.

4.2 Posology And Method Of Administration

For topical administration. There are no differences in use between adults, children and the elderly.

4.3 Contraindications

No contraindications known for clinical conditions.

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 occasionally been attributed to the application of isopropyl alcohol (infrequent, minor).

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

70% isopropyl alcohol has disinfectant properties and 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. Pharmacokinetic particulars are not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water; absorbent viscose pad.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Flammable contents, flash point 24^oC. Product/contents should be kept away from a naked flame. The product should be stored in a cool dry place, away from direct sunlight.

6.5 Nature And Contents Of Container

Printed aluminium foil laminated sachets (laminates of coated paper/polyethylene/aluminium foil/surlyn, the surlyn layer innermost). The sachets are in strips of two, separated by serrations. 100 sachets are packed per carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0025

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd June 2006.

10. Date Of Revision Of The Text

June 2006.