KCENTRA PACKAGE INSERT PDF

This document is provided in portable document format PDF. If you do not have Adobe Reader, download it from the Adobe website. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events.

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The relationship between this or other INR values and clinical hemostasis in patients has not been established [see Clinical Studies 14 ]. Do not use Kcentra beyond the expiration date on the vial label and carton.

Kcentra is for single use only. Contains no preservatives. Discard partially used vials. Table 2: Kcentra Reconstitution Instructions 1. Ensure that the Kcentra vial and diluent vial are at room temperature. Remove flip caps from the Kcentra and diluent vials. Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial package.

Open the Mix2Vial package by peeling off the lid Fig. Do not remove the Mix2Vial from the blister package. Place the diluent vial on an even, clean surface and hold the vial tight.

Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the diluent vial stopper Fig. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.

Make sure that you only pull away the blister package and not the Mix2Vial set Fig. Place the Kcentra vial on an even and firm surface. Invert the diluent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the Kcentra vial stopper Fig. The diluent will automatically flow into the Kcentra vial. In this case, separate the set into two pieces as illustrated in Fig. Place the Kcentra vial aside on a flat surface.

Remove the blue adapter end from the diluent vial of the Mix2Vial set Fig. For reconstitution: Using a separate sterile needle and syringe, withdraw the remaining diluent. Remove the needle from the syringe. Attach the syringe to the transparent adapter of the Kcentra vial as illustrated in Fig. Remove syringe. Gently swirl the Kcentra vial to ensure the product is fully dissolved.

Do not shake. Proceed to step With one hand, grasp the Kcentra -side of the Mix2Vial set and with the other hand grasp the diluent-side and unscrew the set carefully counterclockwise into two pieces Fig. Discard the diluent vial with the blue Mix2Vial adapter attached. Gently swirl the Kcentra vial with the transparent adapter attached until the substance is fully dissolved Fig.

Draw air into an empty, sterile syringe. Inject air into the Kcentra vial Fig. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly Fig. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe keeping the syringe plunger facing down and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise Fig.

Attach the syringe to a suitable intravenous administration set. If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial transfer set for each product vial. Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration whenever solution and container permit.

Reconstituted Kcentra solution should be colorless, clear to slightly opalescent, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates. Use aseptic technique when administering Kcentra. Administer at room temperature.

Administer by intravenous infusion at a rate of 0. No blood should enter the syringe, as there is a possibility of fibrin clot formation. Kcentra potency units is defined by Factor IX content. The actual content of Factor IX as measured in units of potency for the vial before reconstitution is stated by the expiration date.

Patients with disseminated intravascular coagulation DIC. Patients with known heparin-induced thrombocytopenia HIT. Kcentra contains heparin [see Description 11 ]. If severe allergic reaction or anaphylactic type reactions occur, immediately discontinue administration, and institute appropriate treatment. Patients being treated with VKA therapy have underlying disease states that predispose them to thromboembolic events.

Reversing VKA therapy exposes patients to the thromboembolic risk of their underlying disease. Resumption of anticoagulation should be carefully considered following administration of Kcentra and Vitamin K once the risk of thromboembolic events outweighs the risk of bleeding. Thromboembolic events occurred more frequently following Kcentra compared to plasma in a randomized, plasma controlled trial in subjects requiring urgent reversal of VKA anticoagulation due to acute major bleeding, and the excess in thromboembolic events was more pronounced among subjects who had a history of prior thromboembolic event, although these differences were not statistically significant [see Adverse Reactions 6.

Potential benefits of treatment with Kcentra should be weighed against the potential risks of thromboembolic events [ see Adverse Reactions 6 ]. Patients with a history of thrombotic events, myocardial infarction, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, severe peripheral vascular disease, or disseminated intravascular coagulation, within the previous 3 months were excluded from participating in the plasma-controlled RCT.

Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. Because of the risk of thromboembolism associated with reversal of VKA, closely monitor patients for signs and symptoms of thromboembolism during and after administration of Kcentra [see 17 Patient Counseling Information ].

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Kcentra: Package Insert and Label Information

The relationship between this or other INR values and clinical hemostasis in patients has not been established [see Clinical Studies 14 ]. Do not use Kcentra beyond the expiration date on the vial label and carton. Kcentra is for single use only. Contains no preservatives.

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Kcentra: Package Insert and Label Information (Page 5 of 5)

For intravenous use only. PDR Search 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: Therefore, if a patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is established. 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. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. After reconstitution, administration should begin promptly or within 4 hours.

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