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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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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
Warning: Severe Bleeding and Thrombosis Complications
5.1 Hypersensitivity Reactions
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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
Animal reproduction studies have not been conducted with THROMBIN-JMI. It is also not known whether THROMBIN-JMI can cause...
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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 platelets and catalyzes the...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.2 Animal Toxicology and/or Pharmacology
Thrombin Concentration...
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Clinical Studies
14 CLINICAL STUDIES
Observational Study
A total of 554 subjects were enrolled, in a multicenter, open-label, observational study (MOSAIC...
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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 Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.