HYDREX PINK CHLORHEXIDINE GLUCONATE 0.5% W / V IN 70% V / V DEB

1. Name Of The Medicinal Product

HYDREX^®, PINK CHLORHEXIDINE GLUCONATE 0.5% W/V IN 70% V/V DEB.

2. Qualitative And Quantitative Composition

Chlorhexidine Gluconate Solution 20% BP (Ph Eur) – 2.5% v/v

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

This product is for pre-operative skin disinfection prior to minor surgical procedures.

4.2 Posology And Method Of Administration

This product is applied topically.

4.3 Contraindications

i) Do not use in patients who are hypersensitive to Chlorhexidine.

ii) Do not use in contact with eyes, brain, meninges, middle ear or external ear with a perforated tympanic membrane.

iii) Do not inject.

iv) Do not use in body cavities.

v) When use is to be followed by diathermy do not allow pooling of the fluid to occur and ensure that the skin and surrounding drapes are dry.

4.4 Special Warnings And Precautions For Use

i) Precautions:- irritant skin reaction and generated allergic reactions to chlorhexidine have been reported.

ii) Accidental ingestion:- chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatin or mild soap. Employ supportive measures as appropriate.

iii) Accidental intravenous infusion - blood transfusion may be necessary to counteract haemolysis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

None stated

4.7 Effects On Ability To Drive And Use Machines

None stated

4.8 Undesirable Effects

None stated

4.9 Overdose

None stated

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

None stated

5.2 Pharmacokinetic Properties

None stated

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Denatured Ethanol B 96%

Purified Water BP

111959 Carmoisine (E122)

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

HDPE containers in the following sizes 50 ml, 200 ml, 500 ml, 600 ml, 1000 ml and 2000 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 04509/0018

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006 / November 2008