HYDREX SURGICAL SCRUB CHLORHEXIDINE 4% W / V SKIN CLEANSER

1. Name Of The Medicinal Product

HYDREX SURGICAL SCRUB CHLORHEXIDINE 4% W/V SKIN CLEANSER

2. Qualitative And Quantitative Composition

Chlorhexidine Gluconate 4% w/v

3. Pharmaceutical Form

Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For use as an antiseptic hand wash, a pre-operative hand scrub and a pre-operative skin preparation to surgery.

4.2 Posology And Method Of Administration

Antiseptic Hand Wash - wet the hands and forearms, apply 5 ml of skin cleanser and wash for one minute. Rinse thoroughly and dry.

Pre-operative Surgical Scrub - wet hands and forearms, apply 5 ml of skin cleanser and wash for one minute, cleaning the finger nails with a brush. Rinse and repeat the procedure using a further 5 ml of skin cleanser and wash for 2 minutes. Rinse thoroughly and dry.

Pre-operative Skin Preparation - the patient should wash his whole body with 25 ml of the cleanser on at least two occasions, usually the day before and on the day of the operation.

4.3 Contraindications

Avoid contact with eyes, middle ear, brain and meninges.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep out of the reach and sight of children.

Do not use in body cavities.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions need to be taken when used in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Some users may be hypersensitive to chlorhexidine gluconate or amine oxide, particularly on repeated use.

4.9 Overdose

Chlorhexidine is poorly absorbed. If swallowed treat with gastric lavage. Employ supportive measures as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorhexidine is a bisbiguanide disinfectant which is active against a wide range of Gram-positive and Gram-negative vegetative bacteria. It is also active against some viruses and fungi. It is most active at neutral or slightly acid pH

5.2 Pharmacokinetic Properties

Percutaneous absorption of chlorhexidine gluconate is negligible and leads to clinically insignificant plasma concentrations.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, carcinogenic potential and toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ponceau 4R

Dialkylamine Oxide

Glycerine

Industrial Methylated Spirit

Cellosize

Purified Water

Perfume

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Hydrex Surgical Scrub is packaged in HDPE containers in the following sizes: 100 ml, 250 ml, 500 ml, 2000 ml and 5000 ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

June 2003 / August 2006