ChloraPrep 2% chlorhexidine gluconate w/v / 70% isopropyl alcohol v/v cutaneous solution

Chlorhexidine gluconate 2.0% w/v

Isopropyl alcohol 70% v/v

For excipients see 6.1

Cutaneous Solution.

The solution appears as a clear liquid having an odour of alcohol.

The medicinal product is to be used for disinfection of the skin prior to invasive procedures.

For cutaneous use.

One applicator is used containing 0.67 ml, 1.5 ml, 3 ml, 10.5 ml or 26 ml of the ChloraPrep alcoholic solution.

The choice of applicator will depend on the invasive procedure being undertaken and the clinician's preference.

The applicator is removed from the wrapper and held with the sponge facing downward. The applicator is squeezed gently to break the ampoule containing the antiseptic solution, which is released onto the sponge in a controlled flow (for the 0.67 ml the barrel is squeezed; for the 26 ml applicator the lever is pressed).

The broken ampoule remains safely contained within the applicator. The sponge is gently pressed against the patient's skin in order to apply the antiseptic solution. A back and forth action of the sponge should be used for 30 seconds. The 26 ml applicator includes two swabs. Clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) The area covered should be allowed to dry naturally.

The medicinal product is contra-indicated where patients have shown previous hypersensitivity to chlorhexidine or isopropyl alcohol.

The solution is an irritant to eyes and mucous membranes. It should therefore be kept away from these areas. If the solution comes in contact with the eyes, they should be washed promptly and thoroughly with water.

It should also not be used on open skin wounds, broken or damaged skin, for lumbar puncture or in children less than 2 months of age. In addition, contact with the brain, meninges and middle ear must be avoided.

Prolonged skin contact with alcoholic solutions should be avoided.

Rarely allergic or irritation skin reactions have been reported with chlorhexidine.

For external use only.

Do not use with electrocautery procedures until dry. Remove any soaked materials, drapes or gowns before proceeding.

Alcohol should not be brought into contact with some vaccines and skin test injections (patch tests). If in doubt, consult the vaccine manufacturers' literature.

There are no studies with this product in pregnant or lactating women. However as percutaneous absorption is negligible, there is no reason why this product may not be used during pregnancy or by breast feeding mothers.

No effects are reported.

Rarely allergic or irritation skin reactions have been reported with chlorhexidine and isopropyl alcohol.

There are no reports of this occurring and the nature of the product makes it unlikely.

ATC code D08A C52 (Chlorhexidine, combinations).

Mode of Action: Bisbiguanide antiseptics exert their lethal effect upon bacterial cells through non-specific interaction with acidic phospholipids of the cell membranes.

Since there is little percutaneous absorption of isopropyl alcohol or chlorhexidine gluconate and the medicinal product is indicated for use on pre-injection sites, pharmacodynamic studies have not been undertaken.

There is little absorption of isopropyl alcohol or of chlorhexidine gluconate through intact skin. Pharmacokinetic studies have not been conducted with the product.

There are no preclinical data of relevance to the prescriber that are not already included elsewhere in the SPC.

Purified water.

Chlorhexidine is incompatible with soap and other anionic agents

24 months.

Do not store above 25°C.

Avoid freezing.

Store in the original packaging

The alcoholic solution is contained in a borosilicate Type 1 glass ampoule which is housed in an applicator.

The applicator consists of a HDPE plastic handle/barrel containing the ampoule with the ChloraPrep solution. For the 1.5 ml (both the Frepp^® and standard applicator) and 3 ml, 10.5 ml and 26 ml applicators, the handle is bonded to a Novonette film and a polyester urethane foam. For the 0.67 ml Sepp^® applicator, the barrel is bonded to the polyester urethane foam which is stitch-bonded to a polyester airweave.

The applicator is wrapped in an ethyl vinyl acetate film.

The medicinal product is available as 0.67 ml, 1.5 ml, 3 ml, 10.5 ml and 26 ml fill volumes.

The solution is flammable. Do not use while smoking, or near any naked flames or strong heat source. Avoid exposure of the container and contents to naked flames during use, storage and disposal.

This product is for single use only.

Discard after use as per clinical waste procedures.

CareFusion U.K. 244 Ltd.

43 London Road

Reigate

Surrey RH2 9 PW

(44) 1737-237-940

PL 31760/0002

08/09/2005

19/07/10