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THROMBIN-JMI® (thrombin, topical, bovine origin)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
THROMBIN-JMI® Quick Finder
Highlights
Boxed Warning
WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS
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- THROMBIN-JMI® can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies...
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Indications and Usage
1 INDICATIONS AND USAGE
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For topical use on the surface of bleeding tissue only. Do not inject.
2.1 Reconstitution
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- ...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
THROMBIN-JMI (Thrombin, Topical (Bovine) U.S.P.), Solution for topical use is supplied in the following packages:
Vial: 5,000 IU vial with 5 mL diluent.
Vial: 20,000 IU vial with 20...
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Contraindications
4 CONTRAINDICATIONS
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- Do not inject directly into the circulatory system. Because of its action in the clotting mechanism, THROMBIN-JMI can cause extensive intravascular clotting or death.
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- Do not re-expose...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
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- Allergic reactions, including anaphylactic/...
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Adverse Reactions
6 ADVERSE REACTIONS
The most common adverse reactions (incidence greater than or equal to 2%) following administration of THROMBIN-JMI were: hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Animal reproduction studies have not been...
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Description
11 DESCRIPTION
THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
THROMBIN-JMI requires no intermediate physiological agent for its action. It activates...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been undertaken examining...
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Clinical Studies
14 CLINICAL STUDIES
Observational Study
A total of 554 subjects were enrolled, in a multicenter, open-label,...
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References
15 REFERENCES
- 1.
- Morse DC, Silva E, Bartrom J, et al: Improved bleeding scores using Gelfoam Powder with incremental concentrations of bovine thrombin in a swine liver lesion model. J Throm Thrombolysis...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Not made with natural rubber latex.
THROMBIN-JMI® is supplied in the following packages:
- NDC 60793-215-05
Vial: 5,000 IU vial...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Because THROMBIN-JMI may cause the formation of clots in blood vessels if absorbed systemically, advise patients to consult their physician if they experience leg tenderness or swelling,...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.