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Ethicon, Inc Drugs
FOR TOPICAL USE ONLY. DO NOT INJECT.
The amount of EVITHROM required depends upon the area of tissue to be treated and the method of application.
2.1 Reconstitution Prior to Application
Reconstitute the lyophilized human thrombin powder.
Use aseptic technique when handling vials and syringes.Remove the flip-off plastic cap from the vial to expose the rubber stopper. Using a sterile needle and syringe, add 2 ml of Water for Injection, USP to the glass vial. Shake gently until the solution is clear.
Reconstituted solution is stable for up to 8 hours at room temperature and should be used within this time period.
2.2 Application Techniques
DO NOT INJECT. Use EVITHROM topically.
Apply only on the surface of bleeding tissue.
EVITHROM aloneSponge target surface (do not wipe) or suction free of blood before application. The surface may be flooded with EVITHROM using a sterile syringe and small gauge needle. After treatment, avoid sponging the clot to assure that it remains securely in place.
EVITHROM in conjunction with Absorbable Gelatin Sponge, USPTransfer EVITHROM into a sterile container using aseptic techniques. Immerse gelatin sponge of desired shape in the EVITHROM solution. Vigorously knead the sponge with moistened gloved fingers until all air is expelled and it can return to its original size and shape. Hold the saturated sponge in place with gauze or cotton pledget using moderate pressure until hemostasis is achieved.
The amount of EVITHROM required depends upon the area of tissue to be treated and the method of application. As an approximate guide, volumes up to 10 ml were used in clinical studies where EVITHROM was used in conjunction with Absorbable Gelatin Sponge, USP.
Vials are for single use only. Discard unused contents.
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