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Kcentra Reconstitution Guide (PDF) Important Safety Information Kcentra Preparation and Reconstitution Instructions Kcentra is a blood coagulation factor replacement angina pectoris, or severe peripheral vascular For intravenous use only product indicated for the urgent reversal of acquired disease within the prior 3 months. Kcentra coagulation factor defi ciency induced by Vitamin K might not be suitable for patients with antagonist (VKA—eg, warfarin) therapy in adult thromboembolic events in the prior 3 months. Reconstitute using aseptic techniques with 20 mL or 40 mL of diluent provided with kit patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra Kcentra is contraindicated in patients with known An Instructional Guide Perform a visual inspection of the reconstituted solution prior to administration. is for intravenous use only. anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, It should be colorless, clear to slightly opalescent, and free from visible particles. WARNING: ARTERIAL AND VENOUS IX, X, Proteins C and S, Antithrombin III and human Do not use solutions that are cloudy or have deposits THROMBOEMBOLIC COMPLICATIONS albumin). Kcentra is also contraindicated in patients Patients being treated with Vitamin K with disseminated intravascular coagulation. Because Kcentra is for single use only and must be used within 4 hours following Kcentra contains heparin, it is contraindicated in antagonist therapy have underlying disease patients with heparin-induced thrombocytopenia (HIT). reconstitution. Discard partially used vials states that predispose them to thromboembolic events. Potential benefi ts of reversing VKA Hypersensitivity reactions to Kcentra may occur. If Multiple vials are usually required; contents may be pooled. Use a separate, unused should be weighed against the risk of patient experiences severe allergic or anaphylactic type Mix2Vial transfer set for each product vial thromboembolic events, especially in patients reactions, discontinue administration and institute with history of such events. Resumption of appropriate treatment. anticoagulation therapy should be carefully In clinical trials, the most frequent (≥2.8%) adverse Kcentra Administration Reminders considered once the risk of thromboembolic reactions observed in subjects receiving Kcentra events outweighs the risk of acute bleeding. were headache, nausea/vomiting, hypotension, and years of clinical experience + ® Do not mix Kcentra with other medicinal products, and administer Kcentra Both fatal and nonfatal arterial and venous anemia. The most serious adverse reactions were as Beriplex outside the US thromboembolic complications have been 20 through a separate infusion line thromboembolic events, including stroke, pulmonary reported in clinical trials and postmarketing embolism and deep vein thrombosis. surveillance. Monitor patients receiving Administer Kcentra at room temperature Kcentra, and inform them of signs and symptoms Kcentra is derived from human plasma. The risk of ® Transfer Set of thromboembolic events. Kcentra was not transmission of infectious agents, including viruses and, Administer Kcentra by intravenous infusion at a rate of 0.12 mL/kg/min studied in subjects who had a thromboembolic theoretically, the Creutzfeldt-Jakob disease (CJD) agent Reconstitution of Kcentra Using the Mix2Vial and its variant (vCJD), cannot be completely eliminated. (~3 units/kg/min), up to 8.4 mL/min (~210 units/min) event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular Please see accompanying full prescribing information. No blood should enter the syringe, as there is a possibility of fi brin clot formation accident, transient ischemic attack, unstable Please see full Important Safety Information inside. Please see accompanying full prescribing information, Urgent Warfarin Reversal Urgent Warfarin Reversal including boxed warning. Kcentra Recon Guide.indd 2 1/30/19 10:08 PM Kcentra Reconstitution Instructions Kcentra Support Speak with a Kcentra Hotline For reconstitution: representative for: Mix2Vial Transfer Set 6. Carefully remove the Note: If the vacuum in the Kcentra vial is 8. With one hand, grasp 10. Draw air into an 12. Now that the solution blister package from the the Kcentra-side of the empty, sterile syringe. has been transferred Kcentra Additional Product Information Open the Mix2Vial accidentally lost during reconstitution with Using a separate sterile needle and 4. Mix2Vial set by holding Mix2Vial set and with While the Kcentra vial into the syringe, fi rmly package by peeling off the Mix2Vial device, the transfer with the syringe, withdraw the remaining Medical Inquiries at the rim, and pulling the other hand grasp is upright, connect hold on to the barrel of Hotline the lid. Do not remove Mix2Vial will not work. diluent. Remove the needle from Reconstitution & Administration Support vertically upwards. Make the diluent-side and the syringe to the the syringe (keeping the the Mix2Vial from the the syringe. TOLL-FREE: 1-855-4KCENTRA 1. Ensure Kcentra and diluent vials sure that you only pull In this case, separate the unscrew the set carefully Mix2Vial’s Luer Lock syringe plunger facing Reimbursement Support blister package. (1-855-452-3687) are at room temperature. away the blister package set into two pieces as Attach the syringe to the transparent counterclockwise into fi tting by screwing down) and disconnect and not the Mix2Vial set. illustrated in Fig. 6 below; two pieces. Discard the clockwise. Inject air the transparent Mix2Vial adapter of the Kcentra vial as do not discard the diluent 2. Remove fl ip caps from the illustrated in Fig. 8 below, diluent vial with the 9. into the Kcentra vial. adapter from the years of clinical experience vial. Place the Kcentra vial ® Kcentra and diluent vials. 5. Place the diluent vial on Fig. 5 and transfer the entire blue Mix2Vial adapter syringe by unscrewing + as Beriplex outside the US www.Kcentra.com aside on a fl at surface. 20 an even, clean surface and 7. Place the Kcentra vial on diluent volume into attached. counterclockwise. Remove the blue adapter While keeping the hold the vial tight. Take an even and fi rm surface. the Kcentra vial. 11. Attach the syringe to Wipe the stoppers with the end from the diluent vial syringe plunger pressed, Please see full Important Safety Information inside. 3. the Mix2Vial together Invert the diluent vial with Remove syringe. a suitable intravenous alcohol swab provided and of the Mix2Vial set Gently swirl the Kcentra turn the system upside Please see accompanying full prescribing information, including boxed warning. with the blister package the Mix2Vial set attached 9. administration set. allow to dry prior to opening (Fig. 5) by lifting and Gently swirl the Kcentra vial with the transparent down and draw the and push the spike of and push the spike of the Mix2Vial package. bending the blue vial to ensure the product adapter attached until solution into the syringe the blue adapter end the transparent adapter adapter to the side is fully dissolved. the substance is fully by pulling the plunger 13. After reconstitution, straight down through end straight down Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. through the Kcentra vial until it disconnects Do not shake. dissolved. Do not shake. back slowly. administration should Kcentra® and Beriplex® are registered trademarks of CSL Behring GmbH. the diluent vial stopper. Mix2Vial® is a registered trademark of Medimop Medical Projects Ltd. begin promptly or ® stopper. The diluent will from the diluent vial. Fig. 6 Fig. 8 Biotherapies for Life is a registered trademark of CSL Behring LLC. Proceed to step 10. within 4 hours. ©2019 CSL Behring LLC automatically fl ow into 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA the Kcentra vial. www.CSLBehring.com www.Kcentra.com KCT-0219-JAN19 Urgent Warfarin Reversal Kcentra Recon Guide.indd 1 1/30/19 10:08 PM Important Safety Information Kcentra Preparation and Reconstitution Instructions Kcentra is a blood coagulation factor replacement angina pectoris, or severe peripheral vascular For intravenous use only product indicated for the urgent reversal of acquired disease within the prior 3 months. Kcentra coagulation factor defi ciency induced by Vitamin K might not be suitable for patients with antagonist (VKA—eg, warfarin) therapy in adult thromboembolic events in the prior 3 months. Reconstitute using aseptic techniques with 20 mL or 40 mL of diluent provided with kit patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra Kcentra is contraindicated in patients with known An Instructional Guide Perform a visual inspection of the reconstituted solution prior to administration. is for intravenous use only. anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, It should be colorless, clear to slightly opalescent, and free from visible particles. WARNING: ARTERIAL AND VENOUS IX, X, Proteins C and S, Antithrombin III and human Do not use solutions that are cloudy or have deposits THROMBOEMBOLIC COMPLICATIONS albumin). Kcentra is also contraindicated in patients Patients being treated with Vitamin K with disseminated intravascular coagulation. Because Kcentra is for single use only and must be used within 4 hours following Kcentra contains heparin, it is contraindicated in antagonist therapy
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