KCENTRA PACKAGE INSERT PDF

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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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Rapidly kventra vitamin K-dependent coagulation factors that are depleted by warfarin therapy. Factor II had the longest elimination half-life As with other products derived from or purified with human blood components, the possibility of contamination with hepatitis and other viruses or infectious agents exists in patients receiving human plasma derived factor products like prothrombin complex concentrate.

With the Kcentra vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Kcentra vial. Food and Drug Administration. The relationship between this or other INR values and clinical hemostasis in patients has not been established Preparation and Reconstitution: It is not known whether PCC is excreted in human milk.

Do not mix with other medicinal products; administer through a separate infusion line. No clinically important age-related differences in safety observed. Using prothrombin complex concentrates to rapidly reverse oral anticoagulant effects. PCC has not been studied for use during labor and delivery. Prothrombin complex concentrate PCC is contraindicated in patients with a history of disseminated intravascular coagulation DIC.

Individualize intravenous dosage based on current pre-dose international normalized ratio INRbody weight kgand actual potency of Factor IX as stated on the product carton range: Most common serious adverse effects include thromboembolic events i.

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Reference s National Institutes of Health, U. Thrombin converts fibrinogen to fibrin for clot formation. The coagulation cascade is a series of procoagulant and antithrombotic reactions involving the activation of zymogens. Kcentra with sterile water for injection diluent; available with filter transfer set. With the diluent and Kcentra vial still attached to the Mix2Vial transfer set, gently swirl the Kcentra vial to ensure that the Kcentra is fully dissolved. Do not mix with other drugs; administer through a separate infusion line.

According to the manufacturer, prothrombin complex concentrate PCC should only be used if clearly needed in a breast-feeding woman.

Prothrombin Complex Concentrate, human

Carefully consider resuming anticoagulation after administration of PCC once the risk of thromboembolic events outweighs the risk of acute bleeding. Kcentra Prothrombin complex concentration human prescribing information. Serious, and sometimes fatal, thromboembolic events reported in clinical trials and during postmarketing surveillance. Major Tranexamic acid should not be administered concomitantly with factor IX complex, Factor IX Fc fusion protein, recombinant, or Factor IX concentrates, due to the increased risk of thrombosis.

Reconstitute at room temperature as follows: If patient is to receive more than one vial, the contents of multiple vials may be pooled together; however, use a separate unused Mix2Vial transfer set for each product vial.

Infuse at a rate of 0. By clicking Subscribe, I agree to the Drugs. Major In general, aminocaproic acid should not be administered simultaneously with factor IX complex, factor IX concentrates, factor IX Fc fusion protein, recombinant, and factor IX albumin fusion protein, recombinant due to the increased risk of thrombosis.

If a serious allergic or anaphylactic-type reaction occurs, discontinue immediately and initiate appropriate treatment. Prothrombin complex concentrate is contraindicated in patients with known anaphylactic or severe systemic reactions to prothrombin complex concentrate, heparin hypersensitivity, plasma protein hypersensitivity i. Major The actions of factor X are likely to be counteracted by factor Xa inhibitors such as rivaroxaban.

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Discard partially used vials.

Kcentra Monograph for Professionals –

Center for Drug Evaluation and Research: Protein C is activated by thrombin then exerts an antithrombotic effect by inhibiting factor Va and factor VIIIa leading to a decrease in thrombin formation and has indirect profibrinolytic activity by inhibiting plasminogen activator inhibitor Vaxelis Vaxelis is a hexavalent combination vaccine indicated for active immunization Do not mix Kcentra with kcentfa medicinal products; administer through a separate infusion line.

Importance of informing patients of signs and symptoms of thrombosis e. BL Warning Risk of Thromboembolism Risk of serious, and potentially fatal arterial and venous thromboembolic events e. Administer by intravenous infusion at a rate of 0.

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Kankakee, IL; April. Am J Health Syst Pharm. Kcentra was not studied in subjects who had a thrombotic or thromboembolic TE event within the prior 3 months.

Open the Mix2Vial transfer set package by peeling away the lid.

KCENTRA™ – GlobalRPH

Use reconstituted solution within 4 kcentfa. Following administration of the drug, carefully consider resuming oral anticoagulant therapy as soon as risk of thromboembolism outweighs risk of acute bleeding.

While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the nisert by pulling the plunger back slowly. Avoid concomitant use of other procoagulant agents e. There is also the possibility that unknown infectious agents may be present.

Only plasma that passed virus screening is used for production.