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.

Author: Tezil Kesho
Country: Great Britain
Language: English (Spanish)
Genre: History
Published (Last): 19 May 2006
Pages: 92
PDF File Size: 4.92 Mb
ePub File Size: 4.18 Mb
ISBN: 571-3-47715-717-5
Downloads: 21008
Price: Free* [*Free Regsitration Required]
Uploader: Akinom

Prepare and administer using aseptic technique. 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. We comply with the HONcode standard for trustworthy health information – verify here. The safety and effectiveness of repeat dosing have not been established and is not recommended. With one hand, grasp the Kcentra side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces.

Kcentra Monograph for Professionals –

Aminocaproic acid has been used concurrently with human factor IX complexes or anti-inhibitor coagulant complex perioperatively in hemophiliac patients. Do not use solutions that are cloudy or have deposits. Patients with a thromboembolic event, myocardial infarction, DIC, stroke, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the previous 3 months were excluded from clinical trials of PCC.

Use in conjunction with vitamin K phytonadione inseert maintain adequate levels of coagulation factors once the effects of prothrombin complex concentrate human have diminished. Only plasma that passed virus screening is used for production.

inxert Weigh the benefits of reversing VKA therapy against the potential risks of thromboembolism, especially in patients with a history of thromboembolic disease. Subscribe to receive email notifications whenever new articles are published. Studies using human parvovirus B19, which are considered experimental in nature, have packkage a virus reduction factor of 3.

  BUILDING SERVICES ENGINEERING DAVID V CHADDERTON PDF

If more than one vial is required for a dose, may pool reconstituted contents of multiple vials; however, use separate transfer filter sets to reconstitute each vial.

Maximum dose units in patients with baseline INR 4—6.

Because of the increased risk of thromboembolic events, PCC may not be suitable for use in patients with a thromboembolic disease event in the previous 3 months. Prior to reconstitution, allow injection concentrate and sterile water for injection diluent to warm to room temperature.

Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: The relationship between this or other INR values and clinical hemostasis in patients has not been established Preparation and Reconstitution: Table jnsert shows the virus clearance during the manufacturing process pxckage Kcentra, expressed as the mean log10 reduction factor.

Ensure that the Kcentra vial and diluent vial are at room temperature. 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.

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. Send the page ” ” to a friend, relative, colleague or yourself. Vitamin K is administered to lackage Vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished. To administer, attach the lackage to a suitable intravenous administration set.

Use only if clearly needed.

PDR Search

Place diluent vial on a flat surface and hold tightly. Measurement of INR prior to treatment and close to the time of dosing is important because coagulation factors may be unstable in patients with acute major bleeding or an urgent need for surgery and other invasive procedures.

Administer by IV infusion as a single dose. Monitor for signs and symptoms of thromboembolism during and after administration of PCC. Use aseptic technique when administering Kcentra. After reconstitution, administration should begin promptly or within 4 hours. Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Am J Health Syst Pharm.

  GASTON BELIER TOCCATA PDF

Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

The procedures provided in Table 2 are general guidelines for the preparation and reconstitution of Kcentra. This transient effect may occur because protein C also is a vitamin K-dependent plasma inserg with a much shorter half-life than other vitamin K-dependent proteins such as Factor II, IX and X. Ultomiris Ultomiris ravulizumab-cwvz is a long-acting C5 complement inhibitor for the Using prothrombin complex concentrates to rapidly reverse oral anticoagulant effects. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit.

If the kcentar patient is to receive more than one vial, you may pool the contents of multiple vials. In a trial of 98 anticoagulated patients with acute major bleeding, the median INR was 3.

Pharmacologic interventions for reversing the effects of oral anticoagulants. Patients being treated with Vitamin K antagonists VKA therapy have underlying disease kcentfa that predispose them to thromboembolic events.

Prothrombin Complex Concentrate, human | – A Hematology Oncology Wiki

Prothrombin complex concentrate is contraindicated in patients with known anaphylactic or severe systemic reactions to prothrombin complex concentrate, heparin hypersensitivity, plasma protein hypersensitivity i.

Kcentra is contraindicated in: 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.

In healthy subjects, a single intravenous infusion of prothrombin complex concentrate resulted in a rapid and sustained increase in the plasma concentrations of Factors II, VII, IX, and X as well as kdentra C and S.

Administer by intravenous infusion at a rate of 0. Kcentra potency units is defined by Factor IX content. Risk of serious, and potentially fatal arterial and venous thromboembolic events e.