Thrombin-JMI
Generic name:thrombin, topical (bovine)
Dosage form: topical kit
Drug class:Miscellaneous coagulation modifiers
Medically reviewed by Drugs.com. Last updated on May 1, 2022.
On This Page
- Boxed Warning
- 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
WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS
- Thrombin-JMI® can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency.
- Do not re-expose patients to Thrombin-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V.
- Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
Indications and Usage for Thrombin-JMI
Thrombin-JMI is topical bovine thrombin indicated to aid 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.
In various types of surgeries, solutions of Thrombin-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.
Thrombin-JMI Dosage and Administration
For topical use on the surface of bleeding tissue only. Do not inject.
Reconstitution
- For routine use, reconstitute Thrombin-JMI with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units per mL.
- Where bleeding is profuse, as from abraded 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 per mL are frequently used. Prepare intermediate strengths to suit the n...
