KCENTRA PACKAGE INSERT PDF

Keywords: Kcentra, four factor prothrombin complex concentrate, acute . from package insert with written permission from CSL Behring. inherent risks of factor concentrate therapy. For VKA reversal, Kcentra is dosed to correct INRs of or greater per the package insert.1 Dosing varies by the. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of.

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KCENTRA™ – GlobalRPH

Factor II is converted to thrombin by factor Xa in the presence of calcium, factor V, and phospholipids. The product contents are shown in Table 7 and listed as ranges for the blood coagulation factors.

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After reconstitution, administration should begin promptly or inserr 4 hours. The vascular endothelium provides a protective barrier separating blood cells and plasma factors from subendothelial vessel wall reactive adhesive proteins and tissue factor; the proteins trigger blood coagulation.

Place the diluent vial on a flat surface and hold inserf vial tightly. Carefully consider resuming anticoagulation after administration of PCC once the risk of thromboembolic events outweighs the risk of acute bleeding.

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Perioperative hemostatic management of patients treated with vitamin K antagonists. Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. If cooled, warm to 20—25 degrees C 68—77 degrees F prior to administration. Inject air into the Kcentra vial. Closely monitor for manifestations of thromboembolism during and after treatment. Aminocaproic acid has been used concurrently with human factor IX complexes or anti-inhibitor coagulant complex perioperatively in hemophiliac patients.

Westlake Village, CA; July. Your Name Your name is required. Available for Android and iOS devices. According to the manufacturer, prothrombin complex concentrate PCC should only be used if clearly needed in a breast-feeding woman. Ultomiris Ultomiris ravulizumab-cwvz is a long-acting C5 complement inhibitor for the Prothrombin complex concentrate contains heparin and is therefore contraindicated in patients with known heparin-induced thrombocytopenia HIT.

No clinically important age-related kcenra in safety observed. Ensure vials of prothrombin complex concentrate PCC and diluent provided are at room temperature, and use aseptic technique to reconstitute. For patients weighing more than kg, maximum dose should not be exceeded. Administer at room temperature using aseptic technique. Source Plasma 21 CFR The risk of developing thrombosis, however, is increased.

Prothrombin Complex Concentrate, human

Avoid concomitant use of other procoagulant agents e. Clinical pharmacology Mechanism of Action: Evidence-based management of anticoagulant therapy: Do not allow blood to enter the syringe as there is a possibility of fibrin clot formation. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial.

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Administer by IV infusion as a single dose. Following administration of the drug, carefully consider resuming oral anticoagulant therapy as soon as risk of thromboembolism outweighs risk of acute bleeding. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

Kcentra is for single use only. Open the Mix2Vial transfer set package by peeling away the lid. From FDA web site http: Importance of informing patients of signs and symptoms of thrombosis e. Concomitant administration of kcenyra acid with purer formulations of factor IX may also result in an increased risk of thrombosis.

Use only if clearly needed.