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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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. We do not record any personal information entered above.

Administer Vitamin K concurrently to patients receiving Kcentra. Maximum dose units in patients with baseline INR 4—6. 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 pafkage stopper of the Kcentra vial.

Upon initiation of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors.

Prothrombin Complex Concentrate, human

Weigh the benefits of reversing VKA therapy against the potential risks of thromboembolism, especially in patients with a history of thromboembolic disease. Kcentra potency units is defined by Factor IX content. Major The risk of a potential interaction between factor VIIa, recombinant, and factor IX replacement products has not been adequately evaluated. No clinically important age-related differences in safety observed. Available for Android and iOS devices. Prothrombin complex concentrate for critical bleeding.

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Discard partially used vials. We comply with the HONcode standard for trustworthy health information – verify here. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists.

Prothrombin Complex Concentrate, human | – A Hematology Oncology Wiki

Ensure that the Kcentra vial and diluent vial are at room temperature. Perioperative hemostatic management of patients treated with vitamin K antagonists.

In a trial of 98 anticoagulated patients with acute major bleeding, the median INR was 3. Kcentra is made from human blood icentra may carry a risk of transmitting infectious agents, e. This transient effect may occur because protein C also is a vitamin K-dependent plasma protein with a much shorter half-life than other vitamin K-dependent proteins such as Factor II, IX and X. Avoid concomitant use of other procoagulant agents e. Carefully consider resuming anticoagulation after administration of PCC once the risk of thromboembolic events outweighs the risk of acute bleeding.

Monitor INR and clinical response during and after treatment. Reconstitute using aseptic technique with 20 mL U kit kecntra 40 mL U kit of diluent provided with the kit.

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Factor Xa forms a complex with activated FV FVa that converts prothrombin to thrombin in the presence of phospholipids and calcium ions. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit.

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Use aseptic technique when administering Kcentra. Clinical pharmacology Mechanism of Action: Carefully consider resumption of oral anticoagulant therapy as soon as risk of thromboembolism outweighs risk of bleeding.

If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

According to the manufacturer, prothrombin complex concentrate PCC should only be used if clearly needed in a breast-feeding woman. Use only if clearly needed. The procedures provided in Table 2 are general guidelines for the preparation and reconstitution of Kcentra.

Repeat dosing is not recommended. It is not known whether PCC is lnsert in human milk. The free form of protein S functions as a cofactor for activated protein C in the inactivation of factor Va and factor VIIIa, leading to antithrombotic activity.

Importance of informing patients of the signs and symptoms of allergic hypersensitivity reactions e. Determine dose based on patient’s pretreatment INR and body weight up to, but not exceeding kg.

Only plasma that passed virus screening is used for production.

Kcentra Monograph for Professionals –

Packate concurrently with phytonadione. 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. Major Use factor X cautiously with other plasma products that may contain factor X e.