Thrombin Human
Dosage form: powder, for solution
Drug class:Miscellaneous coagulation modifiers
Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Indications and Usage for Thrombin Human
EVITHROM® Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
EVITHROM® Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Thrombin Human Dosage and Administration
Dose
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. 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.
Preparation
- Use aseptic technique when handling vials and syringes.
- Remove the flip-off plastic cap from the vial to expose the rubber stopper.
- Reconstitute the lyophilized human thrombin powder with 2 ml of sterile Water for Injection, USP using the provided reconstitution device.
- 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.
Application Techniques
Apply only on the surface of bleeding tissue.
EVITHROM® Use alone
- Sponge target surface (do not wipe) or suction free of blood before application.
- Flood the surface with EVITHROM® using a sterile syringe and small gauge needle.
- Avoid sponging after treatment, to ensure that the clot remains securely in place.
EVITHROM® in conjunction with Absorbable Gelatin Sponge, USP
- Prepare the desired sh...