SUMMARY OF PRODUCT CHARACTERISTICS

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.

Contraindications

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

Known hypersensitivity-to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

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.

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Hydrex Surgical Scrub, care must be taken to ensure no excess product is present prior to application of the dressing.

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

Immune disorders

- Frequency not known

-    Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4) to chlorhexidine gluconate or amine oxide, particularly on repeated use.

Skin disorders Frequency not known:

-    Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and blisters.

-    Chemical burns in neonates.

System Organ Class	Very common (> 1/10)	Common (> 1/100 < 1/10)	Uncommon (> 1/1,000 < 1/100)	Rare (> 1/10,000 < 1/1,000)	Very rare (< 1/10,000)	Not known (cannot be estimated from available data)
Immune System Disorders						Hypersensitivity Anaphylactic shock
Skin and Subcutaneous Tissue Disorders						Allergic skin reactions Chemical burns neonates

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

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 Hydroxyethyl Cellulose 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.