Thrombin-JMI (Thrombin Topical) - Indications and Dosage

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, or any medical device approved by FDA for an indicated use with a specified, approved dosage of Thrombin, Topical (Bovine Origin).

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 U.S. units/mL. Where bleeding is profuse, as from abraided surfaces of liver or spleen, concentrations of 1,000 U.S. units per mL may be required. For general use in plastic surgery, dental extractions, skin grafting, etc. solutions containing approximately 100 U.S. 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.

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 needle. If the transfer needle is used for reconstitution, transfer the diluent in the following manner.

1. Remove the plastic cap off of the diluent vial.
2. Twist the clear plastic cover on the transfer needle and remove.
3. Insert the exposed needle into the diaphragm of the diluent vial.
4. Flip the plastic cover up on the THROMBIN-JMI® container. DO NOT REMOVE THE COVER AND ALUMINUM SEAL.
5. Remove the pink plastic cap from the transfer needle exposing the needle.
6. Invert the vial of diluent and insert the exposed needle into the diaphragm of the THROMBIN-JMI® container.

THROMBIN-JMI® SPRAY KIT

Each spray kit contains one vial of THROMBIN-JMI® 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® to desired potency by introducing sterile isotonic saline with a sterile syringe or a sterile transfer needle. If the transfer needle is used, follow the previously described procedure.
4. When the THROMBIN-JMI® is completely dissolved, open vial by flipping up metal and tearing counterclockwise.
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® SYRINGE SPRAY KIT

Each syringe kit contains one vial of THROMBIN-JMI® 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 needle, draw the desired amount of saline diluent from the vial into the syringe.
4. Inject the saline diluent into the THROMBIN-JMI® thrombin vial from the syringe to reconstitute the THROMBIN-JMI® thrombin powder.
5. When the THROMBIN-JMI® powder is completely dissolved, draw the THROMBIN-JMI® Thrombin solution into the syringe.
6. Replace the needle guard.
7. Turn needle guard counterclockwise and remove and discard the needle.
8. Affix spray tip by pushing down and turning clockwise until the spray tip locks in place.
9. To spray, depress the syringe plunger in a normal fashion to dispense the THROMBIN-JMI® Thrombin solution through the tip in a fine spray.
10. Discard unused contents 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®.

1. The recipient surface should be sponged (not wiped) free of blood before THROMBIN-JMI® 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® 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® may be used in conjunction with Absorbable Gelatin Sponge, USP as follows:

1. Prepare THROMBIN-JMI® solution to desired strength.
2. Immerse sponge strips of the desired size in THROMBIN-JMI® 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® is supplied in the following packages:

NDC 052604-7100-1

1,000 U.S. unit vial.

NDC 052604-7102-1

5,000 U.S. unit vial with 5 mL diluent.

NDC 052604-7104-3

10,000 U.S. unit vial with 10 mL diluent.

NDC 052604-7105-3

20,000 U.S. unit vial with 20 mL diluent.

NDC 052604-7106-1

50,000 U.S. unit vial.

THROMBIN-JMI® Spray Kit is supplied in the following packages:

NDC 052604-7102-2

5,000 U.S. unit vial with 5 mL diluent, spray pump and actuator.

NDC 052604-7104-2

10,000 U.S. unit vial with 10 mL diluent, spray pump and actuator.

NDC 052604-7105-2

20,000 U.S. unit vial with 20 mL diluent, spray pump and actuator.

THROMBIN-JMI® Syringe Spray Kit is supplied in the following packages:

NDC 052604-7354-2

10,000 U.S. unit vial with 10 mL diluent, spray tip and syringe.

NDC 052604-7355-2

20,000 U.S. unit vial with 20 mL diluent, spray tip and syringe.

STORAGE

Store 1,000 unit vial THROMBIN, TOPICAL (Bovine) THROMBIN-JMI® at 2-8°C (36-46°F). Store 5,000, 10,000, 20,000 and 50,000 unit/vial sizes of THROMBIN-JMI® at 2-25°C (36-77°F).

Distributed By:

JONES PHARMA INCORPORATED

(a wholly owned subsidiary of King Pharmaceuticals, Inc.)

St. Louis, MO

Manufactured by:

GenTrac, Incorporated

Middleton, Wisconsin 53562

U.S. License No. 977

Rev. 9/00