AQUASEPT SKIN CLEANSER - summary of medicine characteristics

Aquasept Skin Cleanser

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Triclosan 2.0%w/v

A clear blue solution

4.1 Therapeutic indications

This product has an antibacterial effect and is intended for the following uses: Prevention of cross infection

Prevention of self-infection

For preoperative hand disinfection

As an antiseptic skin cleanser

For whole body bathing prior to elective surgery

For whole body bathing to help eliminate carriage of pathogens

4.2 Posology and method of administration

For preoperative hand disinfection (100ml, 250ml, 500ml, 5l):

Wet area to be cleaned. Apply about 5ml of Aquasept and wash for one minute, paying particular attention to the area around the fingernails and cuticles and between the fingers. Rinse and repeat for two minutes. Rinse thoroughly and dry hands with a sterile towel.

Antiseptic skin cleanser (100ml, 250ml, 500ml, 5l):

Wet area to be cleaned and use Aquasept as a liquid soap, washing thoroughly for one minute. Rinse and dry thoroughly.

Whole body bathing (28.5ml, 100ml, 250ml, 500ml, 5l):

In shower or bath, use Aquasept as a liquid soap, paying particular attention to the hair, perineum, groin, axillae and nares. Take two baths or showers on the two days prior to surgery. Approximately 28.5ml of Aquasept will suffice for one shower or bath.

4.3 Contraindications

None indicated

4.4 Special warnings and precautions for use

For external use only

Avoid contact with the eyes

Keep out of reach of children

Some product excipients may give rise to allergic reactions in some people. In this instance, discontinue use and seek medical advice.

4.5 Interaction with other medicinal products and other forms of interaction None stated

4.6 Fertility, 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

Ingestion: gastric lavage and symptomatic treatment

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Triclosan is a bactericide

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water, MEA lauryl sulphate, cocamide DEA, cocamidopropyl betaine, isopropyl alcohol, propylene glycol, tetrasodium EDTA and triethanolamine, chlorocrescol, sea fresh perfume, patent blue V (E131)

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage None stated.

6.5 Nature and contents of container

HDPE or HDPP container

Polypropylene wadless screw caps or compression moulded screw caps with steran faced pulpboard liner

Sizes: 28.5ml, 100ml, 250ml, 500ml, 5000ml

6.6 Special precautions for disposal Not applicable.

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 16431/0199.