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Thrombin

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Thrombin-JMI

INDICATIONS

THROMBIN-JMI (thrombin topical bovine origin) ® 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 (thrombin topical bovine origin) ® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.

DOSAGE AND ADMINISTRATION

Solutions of Thrombin, Topical (Bovine Origin), USP, THROMBIN-JMI (thrombin topical bovine origin) ® 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 (thrombin topical bovine origin) ® container with an appropriate volume of sterile isotonic saline.

In many situations, it may be advantageous to use THROMBIN-JMI (thrombin topical bovine origin) ® in a dry form on oozing surfaces. THROMBIN-JMI (thrombin topical bovine origin) ® 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 (thrombin topical bovine origin) ® container with a sterile syringe or sterile transfer device. If the transfer device is used for reconstitution, transfer the diluent in the following manner.

  1. Remove the plastic cap off of the diluent vial.
  2. Remove the tyvek cover from the transfer device container. Do not remove the device from the package.
  3. 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.
  4. Flip the plastic cover off on the THROMBIN-JMI (thrombin topical bovine origin) ® container. DO NOT REMOVE THE ALUMINUM SEAL.
  5. Remove the plastic package from the transfer device, taking care to not touch the exposed end of the device.
  6. Invert the vial of diluent and insert the clear end of the transfer device into the diaphragm of the THROMBIN-JMI (thrombin topical bovine origin) ® container.

THROMBIN-JMI (thrombin topical bovine origin) ® PUMP SPRAY KIT

Each spray kit contains one vial of THROMBIN-JMI (thrombin topical bovine origin) ®, one vial of diluent and one spray pump and actuator.

  1. Remove the outer lid by pulling up at the indicated edge. The inner tray is sterile and suitable for introduction into any operating field.
  2. Remove the cover on inner tray to expose sterile contents.
  3. Reconstitute the THROMBIN-JMI (thrombin topical bovine origin) ® to desired potency by introducing sterile isotonic saline with a sterile syringe or a sterile transfer device. If the transfer device is used, follow the previously described procedure.
  4. When the THROMBIN-JMI (thrombin topical bovine origin) ® is completely dissolved, open vial by flipping up metal and tearing counter clockwise.
  5. Remove the rubber diaphragm from vial. Remove pump with protective cap from tray and snap onto vial. Remove protective cap and attach actuator.
  6. To spray, hold vial upright or at a slight angle. Several strokes of the pump will be required to expel the solution.
  7. Discard unused contents and pump: DO NOT TRANSFER SPRAY PUMP TO ANOTHER VIAL.

THROMBIN-JMI (thrombin topical bovine origin) ® SYRINGE SPRAY KIT

Each syringe kit contains one vial of THROMBIN-JMI (thrombin topical bovine origin) ®, one vial of diluent and one spray tip and syringe.

  1. Remove the outer lid by pulling up at the indicated edge. The inner tray is sterile and suitable for introduction into any operating field.
  2. Remove the cover on the inner tray to expose sterile contents.
  3. Using the sterile syringe equipped with a transfer device, draw the desired amount of saline diluent from the vial into the syringe.
  4. Inject the saline diluent into the THROMBIN-JMI (thrombin topical bovine origin) ® thrombin vial from the syringe to reconstitute the THROMBIN-JMI (thrombin topical bovine origin) ® thrombin powder.
  5. When the THROMBIN-JMI (thrombin topical bovine origin) ® powder is completely dissolved, draw the THROMBIN-JMI (thrombin topical bovine origin) ® Thrombin solution into the syringe.
  6. Remove the syringe from the transfer device by turning syringe counter clockwise.
  7. Affix spray tip by pushing down and turning clockwise until the spray tip locks in place.
  8. To spray, depress the syringe plunger in a normal fashion to dispense the THROMBIN-JMI (thrombin topical bovine origin) ® Thrombin solution through the tip in a fine spray.
  9. Discard unused contents and syringe.

THROMBIN-JMI (thrombin topical bovine origin) ® EPISTAXIS KIT

Each epistaxis kit contains one vial of THROMBIN-JMI (thrombin topical bovine origin) ®, one vial of diluent and one nasal drug delivery device.

  1. Remove the outer lid by pulling up at the indicated edge. The inner tray is sterile and suitable for introduction into any operating field.
  2. Remove the cover on the inner tray to expose sterile contents.
  3. Using the sterile syringe equipped with a transfer device, draw the desired amount of saline diluent from the vial into the syringe.
  4. Inject the saline diluent into the THROMBIN-JMI (thrombin topical bovine origin) ® thrombin vial from the syringe to reconstitute the THROMBIN-JMI (thrombin topical bovine origin) ® thrombin powder.
  5. When the THROMBIN-JMI (thrombin topical bovine origin) ® powder is completely dissolved, draw the THROMBIN-JMI (thrombin topical bovine origin) ® Thrombin solution into the syringe.
  6. Remove the syringe from the transfer device by turning syringe counter clockwise.
  7. Affix the nasal drug delivery device on to the syringe by pushing the device down onto the THROMBIN-JMI (thrombin topical bovine origin) ® thrombin solution filled syringe and turn clockwise until the nasal drug delivery device locks in place.
  8. Insert the nasal drug delivery device into the naris and spray the Thrombin-JMI (thrombin topical bovine origin) ® thrombin solution onto the nasal mucosa through the nasal drug delivery device by depressing the syringe plunger using mild or moderate pressure on the syringe plunger. If feasible, the bleeding site on the patient's nasal mucosa may be placed in a dependent position during administration of Thrombin-JMI (thrombin topical bovine origin) ®.
  9. After administration of Thrombin-JMI (thrombin topical bovine origin) ®, the device may be removed immediately or briefly held in the nasal passage.
  10. Discard the unused contents, nasal drug delivery device, and the 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 24 hours, or may be stored at room temperature for up to 8 hours after reconstitution.

The following techniques are suggested for the topical application of THROMBIN-JMI (thrombin topical bovine origin) ®.

  1. The recipient surface should be sponged (not wiped) free of blood before THROMBIN-JMI (thrombin topical bovine origin) ® is applied.
  2. A spray may be used or the surface may be flooded using a sterile syringe and small gauge needle. The most effective hemostasis results occur when the THROMBIN-JMI (thrombin topical bovine origin) ® mixes freely with the blood as soon as it reaches the surface.
  3. Sponging of the treated surfaces should be avoided to assure that the clot remains securely in place.

THROMBIN-JMI (thrombin topical bovine origin) ® may be used in conjunction with Absorbable Gelatin Sponge, USP as follows:

  1. Prepare THROMBIN-JMI (thrombin topical bovine origin) ® solution to desired strength.
  2. Immerse sponge strips of the desired size in THROMBIN-JMI (thrombin topical bovine origin) ® solution. Knead the sponge strips vigorously with moistened, gloved fingers to remove trapped air, thereby facilitating saturation of the sponge.
  3. Apply saturated sponge to bleeding area. Hold in place with a pledget of cotton or a small gauze sponge until hemostasis occurs.

HOW SUPPLIED

THROMBIN-JMI (thrombin topical bovine origin) ® is supplied in the following packages:

NDC 52604-7102-1
Vial: 5,000 IU vial with 5 mL diluent.

NDC 52604-7105-3
Vial: 20,000 IU vial with 20 mL diluent.

THROMBIN-JMI (thrombin topical bovine origin) ® Pump Spray Kit is supplied in the following packages:

NDC 52604-7105-2
Pump Spray Kit: 20,000 IU vial with 20 mL diluent, spray pump and actuator.

THROMBIN-JMI (thrombin topical bovine origin) ® Syringe Spray Kit is supplied in the following packages:

NDC 52604-7355-2
Syringe Spray Kit: 20,000 IU vial with 20 mL diluent, spray tip and syringe.

THROMBIN-JMI (thrombin topical bovine origin) ® Epistaxis Kit is supplied in the following packages:

NDC 60793-205-05
5,000 IU vial with 5 mL diluent, nasal drug delivery device and syringe.

Storage

Store THROMBIN-JMI (thrombin topical bovine origin) ® at 2°–25°C (36°–77°F).

Distributed By: Jones Pharma Incorporated, Bristol, TN 37620. Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562. FDA Rev date: n/a

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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