Generic name: thrombin, topical (bovine)
Dosage form: topical kit
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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 abraided 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 sterile isotonic saline diluent may be transferred into the THROMBIN-JMI® container with a sterile syringe or sterile transfer device. If the transfer device is used for reconstitution, transfer the diluent in the following manner.
- Remove the plastic cap off of the diluent vial.
- Remove the tyvek cover from the transfer device container. Do not remove the device from the package.
- Seat the blue end of the device on the diluent vial, pushing down until the spike penetrates the diaphragm and the device snaps in place.
- Flip the plastic cover off on the THROMBIN-JMI® container. DO NOT REMOVE THE ALUMINUM SEAL.
- Remove the plastic package from the transfer device, taking care to not touch the exposed end of the device.
- Invert the vial of diluent and insert the clear end of the transfer device into the diaphragm of the THROMBIN-JMI® container.
CAUTION: Solutions should be used promptly upon removal from the container. However, the solution may be refrigerated at 2°-8°C for up to 24 hours, or may be stored at room temperature for up to 8 hours after reconstitution.