Labeled Warnings

Contraindications:

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

Special warnings and precautions for use:

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

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 ChloraPrep with Tint, care must be taken to ensure no excess product is present prior to application of the dressing.

For external use only on intact skin.
ChloraPrep with Tint contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. ChloraPrep with Tint should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound1, 2.

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. 

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.

Do not use on open skin wounds. Do not use on broken or damaged skin. In addition, direct contact with neural tissue or the middle ear must be avoided.  

Prolonged skin contact with alcohol containing solutions should be avoided.
It is important to ensure that the correct method of applications is strictly followed1.  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.


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Notes

1 Contraindications
Known hypersensitivity to ChloraPrep with Tint or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions

2 Undesirable effects
Skin disorders: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. Frequency not known: dermatitis, eczema, urticaria, chemical burns in neonates.At the first sign of local skin reaction the use of ChloraPrep with Tint should be discontinued. 

Immune disorders: 
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

The most commonly reported adverse reactions reported are associated with application site reactions. These were noted to occur most often within the area of application of the solution (i.e. at the prep site) and very rarely spread. The adverse reactions were often self-limiting in nature or resolved following treatment with topical steroids and / or antihistamines. The most commonly reported reactions were non-serious in nature and included application site rash, application site erythema, application site vesicles, application site pain and application site pruritus. Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of suspected adverse reactionsReporting 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 Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard.

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