Thrombinjmi thrombin, topical, bovine origin dosage and. Thrombinjmi fda prescribing information, side effects. Powerful testing performance with a compact footprint. Postoperative hemorrhage control is managed in several ways, and more. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Tell all of your health care providers that you take thrombin jmi thrombin. Factor iia, fiia, fibrinogenase, thrombase, tropostasin, activated bloodcoagulation factor ii expasyswissprot p00734 product description thrombin is an endolytic serine protease that. Antithrombin recombinant us package insert atryn for injection february 3, 2009 3 dosage forms and strengths atryn is a sterile lyophilized formulation. Thrombin from human plasma catalog number t6884 storage temperature 20 c cas rn 9002044 ec 3. Apply powder thrombin jmi directly to the bleeding area or on oozing surfaces may soak in up to 10 ml of absorbable gelatin sponge evithrom applied on bleeding surface wet product with up to 3 ml, 10 ml, or 20 ml of thrombigel 10, 40, 100, respectively, of 0. Thrombinjmi pump spray kit topical coagulant thrombin. Tell your doctor if you are pregnant, plan on getting pregnant, or are breastfeeding. Clinical use of topical thrombin as a surgical hemostat.
Also contained in the preparation are mannitol and sodium chloride. If the transfer device is used for reconstitution, transfer the diluent in the following manner. The inner tray is sterile and suitable for introduction into any operating field. Mar 02, 2018 thrombin jmi, thrombin, topical, is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. Previously, human thrombin was only used in fda approved combination products, namely floseal baxter. Thrombinjmi aka thrombin, topical bovine is a human prescription drug.
Thrombin is a coagulant drug that works by encouraging your blood to clot. Mar 19, 2020 thrombinjmi pump spray kit is supplied in the following package. For routine use, reconstitute thrombinjmi with sterile isotonic saline at a. A multidisciplinary expert group consensus article pdf available in clinical and applied thrombosishemostasis 171. Pfizer rxpathways connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, copay help, and medicines for free or at a savings. These highlights do not include all the information. In instances where a concentration of approximately 1,000 unitsml is desired, the contents of the vial of sterile isotonic saline diluent may be transferred into the thrombinjmi container with a sterile syringe or. Thrombin jmi thrombin solution according to the directions for use in the gelflow nt package insert. Recothrom, thrombin topical recombinant package insert. If you have any questions about thrombinjmi thrombin, please talk with your doctor, nurse, pharmacist, or other health care provider.
After reconstituted, the final solution contains 8001200 unitsml of human thrombin. Calibration plasma 0020000000 0008467300 normal control 0020003120 0020003110 low abnormal control 0020003220 0020003210. Thrombinjmi thrombin bovine origin dose, indications. Pfizer laboratories div pfizer inc thrombinjmi thrombin. Oct 20, 2008 this study is intended to observe the effects of possible repeat exposure to topical thrombinjmi on aptt. Hemosil thrombin time 0009758515 english insert revision. Reconstituted product is stable for up to 8 hours at room temperature 77 degrees f reconstituted product may be stored for 24 hours under refrigeration 41 degrees f and used within 4 hours after removal from refrigeration store between 36 to 77 degrees f thrombipad. For use with gelflow nt, reconstitute thrombinjmi 5,000 iu powder with 5 ml sterile isotonic saline and use thrombinjmi thrombin solution according to the directions for use in the gelflow nt package insert. Thrombin jmi thrombin, bovine is used to help surgeons stop bleeding that occurs during surgery. Mar 02, 2018 thrombinjmi may also be used with floseal nt according to the directions for use in the floseal nt package insert.
Thrombinjmi epistaxis kit is available as 5,000 iu vial with 5 ml diluent, nasal drug delivery device and syringe. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. After cardiovascular suric aln terv o s, bmd occurs in 3% to 14% of cases. You will need to talk about the benefits and risks to you and the baby. May 22, 2019 thrombinjmi may also be used with floseal nt according to the directions for use in the floseal nt package insert. Thrombinjmi, thrombin, topical bovine, is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. Thrombinjmi pump spray kit is supplied in the following package. Thrombin topical bovine originthrombin jmi generic is hematologic agent, prescribed for hemostasis and for temporary control of moderately to severely bleeding wounds. Human thrombin, thrombinatiii complex, thrombinppack. Adult men and women who are scheduled to undergo qualified surgeries defined as surgeries likely to require the use of an active topical hemostatic agent, but not likely to require transfusion of plasma, and who complete the informed consent process, and who meet all of. Pdf clinical use of topical thrombin as a surgical hemostat. Deerfield, il, usa, and the fibrin glues to be discussed in greater detail later. Tct is a blood test that measures the time it takes for a clot to form in the plasma of a blood sample containing anticoagulant, after an excess of thrombin has been added.
Chapman wc, singla n, genyk y, mcneil jw, renkens kl jr, reynolds tc, murphy a, weaver fa. Medicines company 65293000641 mckesson medicalsurgical. Hemostat thromboplastin liquid is a highly sensitive reagent intended for the manual and automated determination of prothrombin time pt in liquid format. Recognizes murine thrombin western blot applications. The thrombin activity was assessed by time to clot formation, using a fibrinogen concentrate as substrate, after 2, 4, and 6 hours of storage.
Refer to thrombinjmi pump spray kit instructions for spray pump assembly and use. Find patient medical information for thrombinjmi topical on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Aug 05, 2015 register now and get a free online msds binder. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Stability of human thrombin produced from 11 ml of plasma. Results from an unpublished clinical trial of evithrom versus bovine thrombin can be found in the packet insert for evithrom.
The saes reported were associated with postsurgical complications e. See full prescribing information for complete boxed warning. Avitene microfibrillar collagen hemostat bard has joined bd. Use of topical thrombin bovine can stimulate antibody formation against bovine thrombin. The amount of thrombin, temperature and length of incubation must be calibrated for each system. Apply powder thrombinjmi directly to the bleeding area or on oozing surfaces may soak in up to 10 ml of absorbable gelatin sponge evithrom applied on bleeding surface wet product with up to 3 ml, 10 ml, or 20 ml of thrombigel 10, 40, 100, respectively, of 0. The proven solution for controlling bleeding in all surgical.
Prothrombin coagulation factor ii is proteolytically cleaved to form thrombin in the clotting process. Adult men and women who are scheduled to undergo qualified surgeries defined as surgeries likely to require the use of an active topical hemostatic agent, but not likely to require transfusion of plasma, and who complete the informed consent process, and who meet all of the inclusion. The b chain of bovine thrombin includes a carbohydrate portion of mw 2. In many cases the cleavage can be performed using the free intact fusion, or in same cases with the fusion protein bound to a matrix. Thrombinjmi thrombin, topical, bovine origin pfizer. Recothrom, thrombin topical recombinant package insert fda.
Thrombin jmi has been shown to produce a lesser immunogenic response in comparison to a less pure bovine thrombin as a result of an enhanced purification process using membrane filtration to remove most of the antigens found in crude thrombin in an in vitro study. Thrombin definition of thrombin by medical dictionary. Thrombinjmi aka thrombin, topical bovine is a human prescription drug product labeled by pfizer laboratories div pfizer inc. For more information, please call 844 9897284 or visit eligible patients can register for valuable savings offers for nearly 40 brand name medications. Thrombin time 0009758515 english insert revision 032005 additional reagents and control plasmas the following are not supplied with the kit and must be purchased separately. Thrombinjmi thrombin topical bovine origin patient. Potency, expressed in units, is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the world heal. Observational study assessing the impact of exposure to. Thrombinjmi may also be used with floseal nt according to the directions for use in the floseal nt package insert. Feb 14, 2019 at least one serious adverse event sae was reported for 26153 17% subjects treated with human thrombin and 17152 11% subjects treated with bovine thrombin. Solutions of thrombin, topical bovine origin, usp, thrombinjmi.
Remove the outer lid by pulling up at the indicated edge. Thrombin from bovine plasma t75 product description. Thrombin jmi, thrombin, topical bovine, is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. Thrombinjmi information, side effects, warnings and recalls. Thrombinjmi thrombin, bovine is used to help surgeons stop bleeding that occurs during surgery. Due to its factor sensitivity it can be used to assay the activity of coagulation factors in the extrinsic and common pathway of. If the transfer device is used for reconstitution, transfer. Be ready to tell or show what was taken, how much, and.
Thrombinjmi fda prescribing information, side effects and uses. Western blot does not blot human, murine, rat, bovine elisa. This web page contains comprehensive information about ndc code 6079321505. Store between 36 to 77 degrees f thrombin jmi epistaxis. Solutions of thrombinjmi may be reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 u. The use of bovine thrombin has been an effective approach to aiding hemostasis during surgery for over 60 years. Thrombinjmi thrombin, topical, bovine origin dosage. Package insert thrombin, topical bovine origin thrombin jmi. Bovine thrombin is an enzyme that activates factor xiii and converts fibrogen into fibrin. Thrombinjmi thrombin, topical, bovine origin other. Recothrom, thrombogen thrombin dosing, indications. Thrombinjmi thrombin, topical, bovine origin this product information is intended only for residents of the united states. Due to its factor sensitivity it can be used to assay the activity of coagulation factors in the extrinsic and common pathway of coagulation factors ii, v, vii, and x.
Avitene effectively enhances platelet aggregation and the release of proteins to form fibrin, resulting in hemostasis. It is supplied as a sterile powder that has been freezedried in the final container. Oct 27, 2005 chapman wc, singla n, genyk y, mcneil jw, renkens kl jr, reynolds tc, murphy a, weaver fa. For topical use on the surface of bleeding tissue only. Biofac thrombin can be used for measuring the thrombin clotting time. A phase 3, randomized, doubleblind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. Thrombinjmi is a topical thrombin indicated to aid hemostasis wheneve thrombinjmi may be used in conjunction with an absorbable gelatin spo thrombinjmi syringe spray kit is available as 5,000 iu vial with 5 ml. Store between 36 to 77 degrees f thrombinjmi epistaxis. Thrombinjmi syringe spray kit is supplied in the following packages. Bovine thrombin is composed of a light chain a chain, mw 5 kda and a heavy chain b chain, mw 33 kda. If you think there has been an overdose, call your poison control center or get medical care right away. Thrombinjmi is available in the gelfoamjmi powder kit gelfoam absorbable gelatin powder and thrombin, topical bovine u. Antihuman thrombin monoclonal antibody haematologic.
In instances where a concentration of approximately 1,000 unitsml is desired, the contents of the vial of sterile isotonic saline diluent may be transferred into the thrombin jmi. Avitene microfibrillar collagen hemostat is an active absorbable collagen hemostat, proven to accelerate clot formation. Postoperative hemorrhage control is managed in several ways, and more than one method may be used to achieve hemostasis. Therefore its primary use is in the defibrination of plasma to produce serum matrixes to be used as controls and standards. Recothrom, thrombin topical recombinant, is a topical thrombin indicated o aid t hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is. Thrombinjmi, thrombin, topical, is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. Remove the tyvek cover from the transfer device container. Supporting documents older than three years thrombin jmi. Bovine thrombin from rmbio is produced as a lyophilized powder that is activated from highly purified prothrombin. Study of recombinant human thrombin for bleeding during. These highlights do not include all the information needed to use thrombinjmi safely and effectively.
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