8 7.3 6 4 2 0
Alcoholic povidone iodine (n=575) ChloraPrep (n=572)
p=0.02
4.0
2% CHG / 70% IPA didn’t deliver a 45% reduction in SSIs: ChloraPrepTM
did
Preparing patients for caesarean delivery with ChloraPrep cut SSIs by almost half, compared with alcoholic povidone iodine1
Prescribing Information ChloraPrep® cutaneous
& ChloraPrep with Tint 2% chlorhexidine gluconate w/v / 70% isopropyl alcohol v/v solution.
Refer to the Summary of Product Characteristics before
prescribing.
Presentation: ChloraPrep – each applicator contains 0.67ml, 1.5ml, 3ml, 10.5ml or 26ml of 20 mg/ ml chlorhexidine & 0.70 ml/ml isopropyl alcohol; ChloraPrep with Tint – each applicator contains 3ml, 10.5ml or 26ml of 20 mg/ml chlorhexidine & 0.70 ml/ml isopropyl alcohol. Indication: Disinfection of skin prior to invasive medical procedures. Dosage & administration: Applicator volume dependent on invasive procedure being undertaken. May be used for all age groups and patient populations. Use with care in newborn babies and those born prematurely. Applicator squeezed to break ampoule and release antiseptic solution onto sponge. Solution applied by gently pressing sponge against skin and moving back and forth for 30 seconds. The area covered should be allowed to air dry. Contra-indications: Patients with known hypersensitivity to ChloraPrep or ChloraPrep with Tint or any of its components, especially those with a history of possible Chlorhexidine-related allergic reactions. Warnings and precautions: Solution is flammable. Do not use with ignition sources until dry. Do not use in excessive quantities, allow to pool in patient skin folds or drip on materials in contact with patient skin. Remove any soaked materials before proceeding with the intervention. Ensure no excess product is present prior to application of occlusive dressing. For external use only on intact skin, do not use on open skin wounds or broken or damaged skin. Over-vigorous use on fragile or sensitive skin or repeated use may lead to local skin reactions. Avoid prolonged skin contact. Avoid contact with eyes, mucous membranes, middle ear and neural tissue. Chlorhexidine may induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. May cause chemical burns in neonates, with a higher risk in preterm infants and within the first 2 weeks of life. Pregnancy & lactation: Although no studies have been conducted, no effects are anticipated as systemic exposure is negligible. Undesirable effects: Very rare; allergic or irritation skin reactions to chlorhexidine, isopropyl alcohol or sunset yellow (E110, present in ChloraPrep with Tint only), including erythema, rash, pruritus and blisters or application site vesicles, other local symptoms have included skin burning sensation, pain and inflammation.
Frequency not known; hypersensitivity including anaphylactic shock, dermatitis, eczema, urticaria, chemical burns in neonates. Discontinue use at the first sign of local skin reaction. Per applicator costs (ex VAT) ChloraPrep: 0.67ml (SEPP) – 30p; 1.5ml (FREPP) – 55p; 1.5ml – 78p; 3ml – 85p; 10.5ml – £2.92; 26ml – £6.50. ChloraPrep with Tint: 3ml – 89p; 10.5ml – £3.07; 26ml – £6.83. Legal category: GSL. Marketing Authorisation Numbers: ChloraPrep, PL31760/0004 & ChloraPrep with Tint, PL31760-0001. Marketing Authorisation Holder: CareFusion UK 244 Ltd, The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS. Date of Preparation: February 2016.
Reporting suspected adverse reactions is important to monitor the benefit/risk balance of the medicinal product. Reporting forms and information can be found at
www.mhra.
gov.uk/yellowcard. Adverse events should also be reported to CareFusion Freephone number: 0800 0437 546 or email:
CareFusionGB@professionalinformation.co.uk
© 2016 BD. BD and BD Logo are property of Becton, Dickinson and Company. ChloraPrep logo is registered trademark of CareFusion Corporation.
Reference: 1. Tuuli MG et al. N Engl J Med 2016; 374(7): 647-55.
CHG: chlorhexidine gluconate IPA: isopropyl alcohol SSI: surgical site infection
0000CF02997 Issue 1 Date of preparation: November 2016
Incidence of SSIs (% of patients)
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