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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Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Invert diluent vial with Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the PCC vial. Nominal potency is or units per vial, approximately 25 units per mL after reconstitution. The manufacturing processes are designed to reduce the risk of transmitting viral pacmage however, disease may still be potentially transmitted.

Packaage Factor IX complexnanofiltered and vapor heated prescribing information.

Prothrombin Complex Concentrate, human | – A Hematology Oncology Wiki

Each vial contains no preservatives and is for single use only. Administer Vitamin K concurrently to patients receiving Kcentra. 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. By clicking Subscribe, I agree to the Drugs. Major Use factor X cautiously with other plasma products that may contain factor X e.

Your Name Your name is required. Potential risk of transmission of viruses e. Los Angeles, CA; Aug. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Inswrt in clinical trials and post marketing surveillance.

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Kcentra is for single use only. National Institutes of Health, U.

Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months.

Send the page ” ” to a friend, relative, colleague or yourself. The product contents are shown in Table 7 and listed as ranges for the blood coagulation factors. Prothrombin complex concentrate PCC is administered intravenously. Repeat dosing is not recommended.

Open the Mix2Vial transfer set package by peeling away the lid. Your email has been sent. Administer vitamin K concurrently to maintain vitamin K-dependent clotting factor concentrations once the effects of prothrombin complex concentrate have diminished. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk packags an untreated or inadequately treated condition.

Administer inxert room temperature. If the same patient is to receive more than one vial, you may pool the contents of multiple vials.

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Available for Android and iOS devices. Food and Drug Administration. Ensure that the Kcentra vial and diluent vial are at room temperature.

Keep plunger pressed, and invert the system upside down; draw the concentrate into the syringe by pulling back slowly on the plunger. 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 Importance of informing patients that because Kcentra is made from human blood, it may carry a paclage of transmitting infectious agents.

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Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. Draw air into an empty, sterile syringe.

Factor II had the longest elimination half-life Rockville, MD; [June 6, ]. Monitor for signs and symptoms of thromboembolism during and after administration of PCC.

While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. The range of Factor IX units per vial is units for the U kit and units for the U kit.

Kcentra Monograph for Professionals –

Make sure that you pull up only the clear package, not the Mix2Vial transfer set. Place the diluent vial on a flat surface and hold the vial tightly.

Perioperative hemostatic management of patients treated with vitamin K antagonists. According to the manufacturer, administer PCC to a pregnant woman only if clearly needed. No clinically important age-related differences in safety observed. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Table 8 shows the virus clearance during the manufacturing process for Kcentra, indert as the mean log10 reduction factor. Carefully remove the clear package from the Mix2Vial transfer set. Administer at room temperature using aseptic technique. Clinical pharmacology Mechanism of Action: Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe keeping the plunger facing down and unscrew the syringe from the Mix2Vial transfer set.

Prothrombin complex concentrate contains heparin and is therefore contraindicated in patients with known heparin-induced inserr HIT.

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