|DRUGS INDEX | MANUFACTURERS INDEX | ANATOMY | GEOGRAPHY | USA STATISTICS | CHINA STATISTICS | RELIGION | JOBS|
- Drugs index
Thrombin, Topical (Bovine) must not be injected! Apply on the surface of bleeding tissue.
The thrombin in Thrombin, Topical (Bovine Origin) THROMBIN-JMI® 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. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product fri-able and more readily soluble. The material contains no preservative.
THROMBIN-JMI® has been chromatographically purified.
THROMBIN-JMI® requires no intermediate physiological agent for its action. It clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself. The speed with which thrombin clots blood is dependent upon the concentration of both thrombin and fibrinogen.
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.
THROMBIN-JMI® is contraindicated in persons known to be sensitive to any of its components and/or to material of bovine origin.
Because of its action in the clotting mechanism, THROMBIN-JMI® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
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.
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 .
DOSAGE AND ADMINISTRATION
Solutions of Thrombin, Topical (Bovine Origin), USP, THROMBIN-JMI® may be reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units/mL. Where bleeding is profuse, as from abraded surfaces of liver or spleen, concentrations of 1,000 International Units per mL may be required. For general use in plastic surgery, dental extractions, skin grafting, etc. solutions containing approximately 100 International Units/mL are frequently used. Intermediate strengths to suit the needs of the case may be prepared by diluting the contents of the THROMBIN-JMI® container with an appropriate volume of sterile isotonic saline. In many situations, it may be advantageous to use THROMBIN-JMI® in a dry form on oozing surfaces. THROMBIN-JMI® may also be used with FloSeal NT according to the directions for use in the FloSeal NT package insert.
In instances where a concentration of approximately 1,000 units/mL is desired, the contents of the vial of ster-ile isotonic saline diluent may be transferred into the THROMBIN-JMI® container with a sterile syringe or sterile transfer needle. If the transfer needle is used for reconstitution, transfer the diluent in the following manner.
THROMBIN-JMI® SPRAY KIT
Each spray kit contains one vial of THROMBIN-JMI®, one vial of diluent and one spray pump and actuator.
THROMBIN-JMI® SYRINGE SPRAY KIT
Each syringe kit contains one vial of THROMBIN-JMI®, one vial of diluent and one spray tip and syringe.
CAUTION: Solutions should be used promptly upon removal from the container. However, the solution may be refrigerated at 2-8°C for up to three hours.
The following techniques are suggested for the topical application of THROMBIN-JMI®.
THROMBIN-JMI® may be used in conjunction with Absorbable Gelatin Sponge, USP as follows:
THROMBIN-JMI® is supplied in the following packages:
NDC 052604-7102-1...5,000 International Unit vial with 5 mL diluent.
NDC 052604-7105-320,000 International Unit vial with 20 mL diluent.
THROMBIN-JMI® Spray Kit is supplied in the following packages:
NDC 052604-7105-220,000 International Unit vial with 20 mL diluent, spray pump and actuator.
THROMBIN-JMI® Syringe Spray Kit is supplied in the following packages:
NDC 052604-7355-220,000 International Unit vial with 20 mL diluent, spray tip and syringe.
Store THROMBIN-JMI® at 2°-25°C (36°-77°F).
Prescribing Information as of May 2005.
Jones Pharma Incorporated
Bristol, VA 24201
Middleton, Wisconsin 53562
U.S. License No. 977