ChloraPrep^® with Tint 2% w/v / 70% v/v cutaneous solution

Chlorhexidine gluconate 20mg/ml

Isopropyl alcohol 0.70ml/ml

For a full list of excipients, see section 6.1

Cutaneous Solution.

Orange Solution.

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

For cutaneous use.

ChloraPrep with Tint may be used on all age groups and patient populations. However, ChloraPrep with Tint is not recommended for children younger than 2 months old.

One applicator is used containing 3 ml, 10.5 ml or 26 ml of the ChloraPrep with Tint 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 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.

It is recommended that ChloraPrep with Tint remain on the skin post-procedure to provide continued antimicrobial activity. The tint will slowly fade from the skin. If removal is necessary, remove with soap and water or alcohol.

The medicinal product is contra-indicated where patients have shown previous hypersensitivity to chlorhexidine, isopropyl alcohol or Sunset Yellow (E110).

For external use only on intact skin.

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, or in children less than 2 months of age. In addition, direct contact with neural tissue or the middle ear must be avoided.

Prolonged skin contact with alcoholic solutions should be avoided.

The solution is flammable. Do not use with electrocautery procedures or other ignition sources until dry.

Remove any soaked materials, drapes or gowns before proceeding. Do not allow the solution to pool.

It is important to ensure that the correct method of application is strictly followed (see section 4.2 above). When the solution has been applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, local skin reaction may occur including: erythema or inflammation, itching, dry and/or flaky skin and local application site pain. At the first sign of local skin reaction application of ChloraPrep with Tint should be stopped.

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

There are no known risks for the use of this product in pregnant or lactating women.

No effects are reported.

Very rarely (<1/10,000) allergic or irritation skin reactions have been reported with chlorhexidine, isopropyl alcohol and Sunset Yellow (E110) including: erythema, rash (e.g. erythematous, papular, or maculopapular), pruritus and blisters or application site vesicles. Other local symptoms have included skin burning sensation, pain and inflammation.

At the first sign of local skin reaction application of ChloraPrep with Tint should be stopped.

There are no reports of overdose with this product.

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.

Chlorhexidine gluconate is a cationic biguanide. Its antimicrobial action is due to the disruption of the cell membrane and the precipitation of cell contents. It has a bactericidal or bacteriostatic action against a wide range of gram-positive and gram-negative bacteria. It is relatively ineffective against mycobacteria. It inhibits some viruses and is active against some fungi. It is inactive against bacterial spores. It has a superior residual property in comparison to currently available skin antiseptics. Chlorhexidine gluconate has a strong binding property to skin and has a residual property on the skin that has been documented at 48 hour. Chlorhexidine gluconate is not neutralised in the presence of organic matter.

Isopropyl alcohol is rapidly bactericidal and fast acting broad spectrum antiseptic, but is not considered persistent. Its mechanism of action appears to be denaturation of proteins.

ChloraPrep with Tint is a combination of 2% Chlorhexidine gluconate in 70% Isopropyl alcohol, which is effective for both rapid and persistent reduction of bacterial load across various body regions for a broad spectrum of organisms. Isopropyl alcohol (70%) provides an immediate kill of transient and resident microorganisms on the stratum corneum and 2% chlorhexidine gluconate binds to the superficial cell layers of the epidermis and provides a residual, or persistent, antimicrobial property that prevents regrowth of microorganisms.

Clinical studies with 2% Chlorhexidine gluconate in 70% Isopropyl alcohol have demonstrated that the combination offers equal or similar effectiveness in reducing skin bacterial load and more sustained antibacterial effects over longer periods after application, compared to the individual components alone, as well as to other commonly used antiseptics such as Povidone-iodine.

ChloraPrep with Tint meets the criteria for chemical disinfectants and antiseptic products as established by European Standards:

EN 1040 – basic bactericidal activity (Phase 1)

EN 1275 – basic yeasticidal activity (Phase 1)

EN 13727 - bactericidal activity (Phase 2/Step 1)

EN 13624 - fungicidal activity (Phase 2/Step 1)

Table: In vitro microbiocidal effects

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

Sunset Yellow (E110)

Chlorhexidine is incompatible with soap, hypochlorite bleach and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics, which have previously been in contact with preparations containing chlorhexidine.

24 months

Flammable. Do not store above 25°C.

Store in the original packaging; applicator is sterile unless seal is broken.

Avoid exposure of the container and contents to naked flames during use, storage and disposal.

ChloraPrep with Tint is a sterile alcoholic antiseptic solution containing chlorhexidine gluconate and isopropyl alcohol in an applicator. The applicators consist of a latex-free sponge attached to a plastic handle/barrel which holds a latex-free dyed pledget and glass ampoule containing the antiseptic solution. The 3ml and 10.5ml applicators each have a single glass ampoule within the plastic barrel. The 26ml applicator holds two 13ml glass ampoules. The sterile applicators are individually packaged in an ethyl vinyl acetate film.

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

Not all pack sizes may be marketed.

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.

Any unused product or waste material should be discarded in accordance with local requirements.

CareFusion U.K. 244 Ltd.

43 London Road

Reigate, Surrey RH2 9PW

United Kingdom

UK: PL 31760/0001

IE: PA 1435/001/001

MT: MA 700/00100

UK: 23 December 2009

IE: 02 July 2010

MT: 23 February 2010

April 2011