BeneFIX® (coagulation factor IX) Product Monograph Page 1 of 29 PRODUCT MONOGRAPH BeneFIX® Coagulation Factor IX (Recombinant) INN= Nonacog alfa BeneFIX Coagulation Factor IX (Recombinant), is prepared in six lyophilized powder dosage forms nominally containing 250, 500, 1000, 1500, 2000 and Müller MC, Straat M, Meijers JC, et al.Fresh frozen plasma transfusion fails to influence the hemostatic balance in critically ill patients with a coagulopathy. Feiba. Utilizing an NMEA 2000 CAN bus network, system reliability and safety are achieved through a redundant architecture that eliminates single point failures. Take care not to touch the exposed end of the device.  Turn the water vial upside down and insert the clear end into the powdered octaplex vial, pushing down until the spike penetrates the stopper and the device snaps into place.  The water will automatically flow into the octaplex vial. Octaplas TM is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP). Octaplex and FEIBA significantly reduced ECT prolongation versus dabigatran alone at 5 min only . 1000 IU powder and solvent for solution for infusion . DOSE (Refer to Product Insert): Dose is patient and indication specific. On April 23rd 2013, the FDA approved CSL Behring’s product Kcentra as the first 4-Factor Prothrombin Complex Concentrate (PCC) available in the United States for the use in treatment of anti-coagulated patients with acute hemorrhage. The Sign of Four…. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. 2015.Vienna, Austria. Human prothrombin complex . STN: 125416. Indications and Usage. Please consult your physician or pharmacist or product package for this information. Since that first recommendation document, two national audits of octaplex® and licensure of a second product, Beriplex® P/N has occurred. octanine®F. 500 IU powder and solvent for solution for infusion . Turn the water vial upside down and insert the clear end into the powdered octaplex vial, pushing down until the spike penetrates the stopper and the device snaps into place. Cited Here; 28. • Remove box labelled as Emergency Octaplex 1000 iu PCC • Scan out the product using the barcode on the box label On Ward: • Reconstitute using Package Insert instructions • Administer using BloodTrack Tx system via the PDA at the bedside After Administration: • Reversal of warfarin ensure to take repeat INR after 10 minutes Who we are . About us . The infusion should start at a speed of 1ml per minute, followed by 2-3 ml per minute using an aseptic technique. One package contains: OctoPlex® G2-Series. Prothrombin Complex Concentrates - Octaplex / Beriplex. The Carling Technologies’ Octoplex™ system puts the user in complete control of all AC and DC components within the vessel. April;2013. In Meyler's Side Effects of Drugs (Sixteenth Edition), 2016. Octaplex PIL . One package contains: - Powder in a vial (type I glass) with a stopper (halobutyl rubber) and a flip off cap (aluminium) - 20 mL of Water for Injections in a vial (type I glass) with a stopper (halobutyl rubber) and a flip off cap (aluminium) - 1 Nextaro ® transfer device. Human prothrombin complex . About us . The 4F-PCC data are recalculated from Table 7 in the Kcentra (CSL Behring, Kankakee, Illinois) prescribing information package insert (1) and from an unlabeled table in the Octaplex (Octapharma AG, Lachen, Switzerland) prescribing information package insert. PCC required Review indications for use to determine the need for Prothrombin Complex Concentrates (PCCs): Indications INR 1.5 or greater (caused by Warfarin therapy) AND need for immediate Warfarin reversal due to: Major bleeding, and/or Need for an unplanned surgical procedure which cannot be delayed a minimum of 6 hours 1 However, practical considerations seem to preclude such specific calculations in daily practice. 10 mL. prothrombin complex concentrate (PCC) available in Canada, octaplex . What can we help you find? See package insert. Nadir was measured between 5 minutes after bolus until the end of the infusion 1; Rate of excellent or good hemostatic efficacy 12 hours after infusion. Octaplex ® should be stored at 2 -25 oC. Tradename: Octaplas. Our locations. The package insert states that prothrombin complex concentrate is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation, because giving clotting factors would only further fuel this process. Primary efficacy measures. Factor IX is used to determine the concentration of the product. have a 7- to 10-fold higher risk of spontaneous ICH compared with those not receiving treatment Octaplex® is a human four factor prothrombin complex concentrate (4F-PCC) containing Factors II, VII, IX and X, as well as inhibitor protein C and its cofactor protein S. In a prospective, open-label study in 56 patients who required VKA reversal to control bleeding during surgical procedures, PCC treatment (Octaplex) reduced INR to <1.4 within 1 hr after dosing in 93% of patients, with a median decline of INR values from 2.8 to 1.1 within 10 min after dosing . The single dose should not exceed 3000 units for Factor IX (120mls of Octaplex). About us . * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). Octaplex 1000 IU. Consult the Product Monograph or Package Insert for complete details Monitoring (43) The FFP quantities are recalculated from data in Table 1 of Scott et al. Read all of this leaflet carefully before you start using this medicinebecause it NovoSeven had no effect on any of the coagulation assays, despite reducing the prolonged bleeding time at the higher 500 μg/kg dose. Research and Development. (44) Octapharma Canada Inc. (201 7) Octaplex… Corporate responsibility. Human Coagulation Factor VIII (rDNA) (simoctocog alfa) Immunotherapy. Utilizing an NMEA 2000® CAN bus network, system reliability and safety are achieved through a redundant architecture that eliminates single point failures. 2015;13:989–997. Octaplex should be administered intravenously. Prothrombin complex concentrate (PCC) is used for the rapid reversal of vitamin K antagonist (VKA) anticoagulation. Lyophilized Powder for Solution for. 5.1 Hypersensitivity Reactions Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with ELOXATIN within minutes of administration and during any cycle. Rx only. Proper Name: Pooled Plasma (Human), Solvent/Detergent Treated. Octaplas. The Carling Technologies® OctoPlex® system puts the user in complete control of all AC and DC loads within the vessel. Do not use past expiry date . Protocol for the use of OCTAPLEX This is a plasma derived, virally inactivated concentrate of clotting factors II, VII, IX and X. What can we help you find? …Factors that is. Gently swirl the vial to make sure the octaplex is thoroughly mixed. (Octaplex, Beriplex) Reversal of acute major bleeding due to warfarin Activated PCC - 4 Factor Feiba Hemophilia A and B PCC – 3 Factor Profilnine® SD Hemophilia B with factor IX deficiency Recombinant Factor VIIa NovoSeven® RT Patients with factor VII deficiency or with hemophilia A or B Kcentra Package Insert. PCC is also applicable in situations requiring rapid reversal of anticoagulation by non-vitamin K antagonist direct thrombin and factor Xa inhibitor oral anticoagulants (NOACs), thereby making PCC a general antidote for oral anticoagulation. PACKAGE LEAFLET: INFORMATION FOR THE USER . Octaplex 500 (Protein C Human) Concentrate (Human) Octaplex 500 (Protein C Human) Single-dose Vial. Determination of the patient’s fibrinogen level before and during treatment is recommended. Do not store outside of Transfusion Services (Blood bank). This is in part due to the fact the package insert recommendations will correct factor levels to normal despite the fact that normal hemostasis does not require 100% factor levels. Percent change in anti-FXa activity, from baseline to nadir. Octaplex ® 500 IU [package insert, B261007UK]. ‡8 hours for Urgent Surgery/Invasive Procedures trial and 12 hours for Acute Major Bleeding trial. HOBOKEN, NJ, USA I April 29, 2013 I The U.S. Food and Drug Administration (FDA) has accepted Octapharma USA’s Biological License Application (BLA) for octaplex ®.. The TT assay was significantly increased with Octaplex at 5 min and Bebulin at all time points . This is in part due to the fact the package insert recommendations w ill correct factor levels to normal despite the fact that normal hemostasis Who we are octanate®. Resumption of J Thromb Haemost. Faster INR reduction (to ≤1.3 at 30 minutes after end of infusion) in both head-to-head trials. May 20, 2013 by Rory Spiegel 4 Comments. Protocol for the use of OCTAPLEX. This is a plasma derived, virally inactivated concentrate of clotting factors II, VII, IX and X. It also contains the naturally occurring anticoagulants Protein C and Protein S plus Heparin. Octaplex . Also contains heparin and sodium citrate Diluent (sterile water for injection) vial size is 20 mL for 500IU, and 40 mL for 1000IU dose ... end of octaplex® infusion to ensure entire dose has been administered. The package insert for Kcentra dictates that a specific volume-based dose should be calculated and titrated for each patient (specific to the actual factor IX potency of each vial—this information provided with each package of the product). The water will automatically flow into the octaplex vial. Octaplex . About us . RiaSTAP ®, Fibrinogen Concentrate (Human), is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.. Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. However, if the PCC is given because factor levels are low, it can restore normal coagulation. Sterile Water for Injection, USP. Thromboembolic events in relation to activated prothrombin complex products include deep venous thrombosis and pulmonary embolism [3–5].So far, the exact mechanism of how thromboembolic events are stimulated by prothrombin complex products is not known. Human plasma-derived coagulation factor VIII concentrate, naturally stabilised with von Willebrand factor (VWF) Haematology. The working group would also like to highlight that 50% of patients in the audit responded to the previously recommended standardized dose of 1000 IU (40 mL octaplex®). Consult with TM Physician / Pathologist on call for bleeding patients Side-effects . Administer vitamin K concurrently to patients receiving Kcentra. Haematology. For assistance, please send an e- mail to: CSL. Safety Octaplex is a virally inactivated product. NDC 52919-005-05. This is in part due to the fact the package insert recommendations will correct factor levels to normal despite the fact that normal hemostasis does not require 100% factor levels. See product insert for actual amounts. for reconstitution of accompanying product. Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H. MISCELLANEOUS No interaction of Octaplex ® with other medicinal products has been established. octaplex®(Human Prothrombin Complex Concentrate) This site is intended for UK & Ireland members of the public, patients and healthcare professionals. Latex Free REFERENCES 1. 20200331 1/9. 91 mL octaplex / 20 mL per vial = 4.55 vials octaplex (2275 IU octaplex) One vial of octaplex is 20 mL and contains 500 IU FIX . WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Each package includes: lyophilized PCC , diluent (sterile water), transfer set with integrated filter, package insert AVAILABILITY of PRODUCT Supplied by the CBS UH and VH both stock Octaplex ® (manufactured by Octapharma) or Beriplex (manufactured by CSL Behring) and either product will be issued depending on available inventory octagam®. Intravenous Human Normal Immunoglobulin. DESCRIPTION OF PRODUCT:  octaplex ® is a manufactured prothrombin complex concentrate (PCC) that is derived from human plasma Anticoagulation therapy aggravates the risk of intracerebral hemorrhage but, on the other hand, patients take anticoagulants because of an underlying prothrombotic risk, and this could be increased following trauma. Detailed information related to Octaplex Powder's uses, composition, dosage, side effects and reviews is listed below. Individuals using assistive technology may not be able to fully access the information contained in this file. Passive immunization of exposed patients For dose, refer to package insert Prothrombin Complex Concentrates (Octaplex® and Beriplex®) Treatment of major bleeding or in anticipation of urgent surgery in acquired deficiency of the prothrombin complex coagulation factors due to vitamin K antagonists or deficiency (for use in Uses. Important Safety Information. Indications Urgent reversal of Warfarin or another coumarin anticoagulant such as Nicoumalone or Phenindione e.g. Package sizes: Octaplex 500 IU. Organs and systems Cardiovascular. Do not use unless clear. The FDA will evaluate the octaplex ® BLA for the proposed indication of reversal of anticoagulation therapy in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures. Beriplex®/Octaplex® (Prothrombin Complex Concentrates(PCC)): A summary of information, including a link to the Product Monograph, may be found in the Laboratory Service Manual, Product Catalogue: Prothrombin Complex Concentrate. There is a high degree of uncertainty regarding optimum care of patients with potential or known intake of oral anticoagulants and traumatic brain injury (TBI). Injection. For Intravenous Administration Only. Measures taken are Please consult your physician or pharmacist or product package for this information. It also contains the naturally occurring anticoagulants Protein C and Protein S plus Heparin.

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