COVE R S TORY
Combined essential information for persons qualified to prescribe or supply
Prescribing Information: ChloraPrep™ & ChloraPrep with Tint 2% chlorhexidine gluconate w/v / 70% isopropyl alcohol v/v cutaneous solution. Refer to the Summary of Product Characteristics before prescribing. Presentation: ChloraPrep – each applicator contains 0.67ml, 1ml, 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 electrocautery procedures or other ignition sources until dry. Remove any soaked materials before proceeding with the intervention. Do not use in excessive quantities, allow to pool in patient skin folds or drip on materials in contact with patient skin. 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. Chlorhexidine-containing products are known causes of anaphylactic reactions during anaesthesia. The symptoms of anaphylactic reactions might be masked in an anesthetized patient. If symptoms of an anaphylactic reaction are detected during anaesthesia, chlorhexidine related allergic reaction should be considered. When chlorhexidine-related allergic reaction during anaesthesia is suspected, other products containing chlorhexidine used during anaesthesia (e.g. IV lines) should be removed. Special precaution should be taken to avoid patient exposure to any other product containing chlorhexidine during the course of the treatment. 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, eyes irritation, hyperaemia, impaired vision, chemical burn and eye injury. Discontinue use at the first sign of local skin reaction. Cases of anaphylactic reactions have been reported during anaesthesia. Description of selected adverse reactions: There have been isolated spontaneous reports of generalised allergic reactions potentially associated with ChloraPrep solution and have been reported during anaesthesia. In some cases, the patient may have had a pre-existing sensitivity to chlorhexidine. This product may cause a severe allergic reaction. Symptoms may include wheezing/difficulty breathing, shock, facial swelling, hives, or rash. Use of ChloraPrep is contra-indicated where patients have shown previous hypersensitivity to chlorhexidine or isopropyl alcohol (see Section Contra-indications). If hypersensitivity or an allergic reaction occurs, stop use and seek medical help right away. Per applicator costs (ex VAT) ChloraPrep: 0.67ml (SEPP) - UK £0.30, Ireland €0.39; 1ml – UK £0.32, Ireland TBD; 1.5ml (FREPP) - UK £0.55, Ireland €0.64; 1.5ml – UK £0.78, Ireland €0.94; 3ml – UK £0.85, Ireland €1.06; 10.5ml - UK £2.92, Ireland €3.79; 26ml - – UK £6.50, Ireland €7.96. ChloraPrep with Tint: 3ml – UK £0.89, Ireland €1.09; 10.5ml – UK £3.07, Ireland €3.88; 26ml - UK £6.83, Ireland €8.19 Legal category: UK: GSL. Ireland: Not subject to medical prescription. Marketing Authorisation Numbers: ChloraPrep, (UK: PL05920/0002-001; Ireland: PA2287/001/002) & ChloraPrep with Tint, (UK: PL05920/0003- 0001; Ireland: PA2287/001/001) Marketing Authorisation Holder: UK : Becton Dickinson UK Ltd, 1030 Eskdale Road, Winnersh, Wokingham RG41 5TS, United Kingdom. Ireland : Becton Dickinson France, 11 Rue Aristide Bergès, 38800 Le Pont de Claix, France Date of Revision of the API: January 2021.
Ordering information Cat No. Description 5513E 5514U 4406 4412A 4403A
Rechargeable surgical clipper Charging Adapter-UK & Ireland General purpose blade Neuro blade
SensiClip™ blade
Qts. (cs.) 1 1
50 20 20
Ordering information Cat No. Description 2170
References 1. Mimoz, O et al. 2021. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. The Lancet Infectious Diseases; 21(7), 1038-1048.
2. Helm, R., Klausner, J., Klemperer, J., Flint, L. and Huang, E., 2015. Accepted but Unacceptable: Peripheral IV Catheter Failure. Journal of Infusion Nursing, 38(3), 189-203.
3. Rickard, C. et al, 2018. Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial. The Lancet, 392(10145), 419-430.
4. Pyrek K., 2016. Healthcare personnel compliance with infection prevention imperatives, Infection Control Today, 1-10.
5 Lim, S. et al., 2019. Increased Clinical and Economic Burden Associated With Peripheral Intravenous Catheter–Related Complications: Analysis of a US Hospital Discharge Database. INQUIRY: The Journal of Health Care Organization, Provision, and Financing, 56, 1-14.
6. Tuffaha, H. et al., 2014. Cost-Effectiveness Analysis of Clinically Indicated Versus Routine Replacement of Peripheral Intravenous Catheters. Applied Health Economics and Health Policy, 12(1), 51-58.
Surgical skin maker with ruler - sterile 2170NS Surgical skin maker with ruler - non-sterile
Pack size 50
The results of the CLEAN3 trial will be presented at the National Infusion and Vascular Access Safety (NIVAS) Society’s Annual Conference, Wednesday 22 September 2021. https://nivas.
org.uk/conference/9th-annual-nivas- conference-2021
100 NEW CLIPVAC SYSTEM
BD, Building 1030, Eskdale Road, Winnersh Triangle, Berkshire RG41 5TS T: (+44) (0)1189 216255
BD, the BD Logo, Autoguard, ChloraPrep, Insyte, MaxZero, Nexiva, PosiFlush and PureHub are trademarks of Becton, Dickinson and Company or its affiliates. ©2021. All rights reserved. (BD- 41864, August 2021)
BD Purehub™ BD Nexiva™ BD Insyte Autoguard™ CE 0050
CE 2797
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 (for UK) and
www.hpra.ie (for Ireland). Adverse events should also be reported to BD Freephone number: For UK 0800 0437 546 or email:
SafetyInformation@bd.com. For Ireland: +353 01 4287895/7896 or email:
SafetyInformation@bd.com
BD Maxzero™ BD Posiflush™ CE 2797
CE 0050 BD Chloraprep™ is a medicinal product CE 2797
SEPTEMBER 2021
WWW.CLINICALSERVICESJOURNAL.COM l
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