Front Matter - The Journal of Bone & Joint Surgery

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Gets to the Site of the Bleeding Your Trusted Thrombin-on-the-Spot for Fast, Active Hemostasis •Hemostasis achieved within 3 minutes in 71% of patients undergoing spinal surgery who were treated with Thrombin-JMI ® -soaked Absorbable Gelatin Sponge, USP 1 •A biologically active agent that works directly at the end of the coagulation cascade 2 Multiple Delivery Options for Hemostasis— Where You Want It, When You Need It • Thrombin-JMI ® Pump Spray Kit to cover broad oozing areas • Thrombin-JMI ® Syringe Spray Kit for difficult-to-reach bleeding sites* •Thrombin-JMI ® Vials for direct application or use in conjunction with certain passive hemostatic agents Thrombin-JMI ® is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. In various types of surgery, solutions of Thrombin-JMI ® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis. Makes Contact. Takes Action. Thrombin-JMI is a registered trademark of King Pharmaceuticals Research and Development, Inc., a wholly owned subsidiary of King Pharmaceuticals ® , Inc. Copyright © 2006 King Pharmaceuticals ® , Inc. All rights reserved. JMI4276 12/2006 Downloaded From: http://jbjs.org/ on 01/27/2014
THROMBIN, TOPICAL U.S.P. (BOVINE ORIGIN) THROMBIN-JMI ® BRIEF SUMMARY of Full Prescribing Information Thrombin, Topical (Bovine) must not be injected! Apply on the surface of bleeding tissue. INDICATIONS AND USAGE THROMBIN-JMI ® is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. In various types of surgery, solutions of THROMBIN-JMI ® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis. CONTRAINDICATIONS THROMBIN-JMI ® is contraindicated in persons known to be sensitive to any of its components and/or to material of bovine origin. WARNING The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products. Because of its action in the clotting mechanism, THROM- BIN-JMI ® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result. PRECAUTIONS General — Consult the Absorbable Gelatin Sponge, USP labeling for complete information for use prior to utilizing the thrombin saturated sponge procedure. Pregnancy — Category C – Animal reproduction studies have not been conducted with THROMBIN-JMI ® . It is also not known whether THROMBIN-JMI ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBIN-JMI ® should be given to a pregnant woman only if clearly indicated. Pediatric Use — Safety and effectiveness in children have not been established. ADVERSE REACTIONS Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Inhibitory antibodies which interfere with hemostasis may develop in a small percentage of patients. See Warning. Distributed By: Jones Pharma Incorporated, Bristol, VA 24201 Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562 U.S. License No. 977 Rev. 5/05 Jones Pharma Incorporated and GenTrac, Incorporated Jones Pharma are Incorporated wholly owned subsidiaries and GenTrac, of King Incorporated Pharmaceuticals are wholly ® , Inc. owned subsidiaries of King Pharmaceuticals ® , Inc. References: 1. Renkens KL Jr, Payner TD, Leipzig TJ, et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001;26:1645- 1650. 2.Thrombin-JMI [package insert]. Middleton, Wis: GenTrac, Inc; 2005. Downloaded From: http://jbjs.org/ on 01/27/2014
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Front Matter - The Journal of Bone & Joint Surgery

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