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THROMBIN-JMI®(thrombin, topical, bovine origin)

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THROMBIN-JMI® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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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...
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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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2 DOSAGE AND ADMINISTRATION

For topical use on the surface of bleeding tissue only. Do not inject.

2.1 Reconstitution

  • For routine...
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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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4 CONTRAINDICATIONS

  • 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.
  • Do not re-expose patients to THROMBIN-...
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5 WARNINGS AND PRECAUTIONS

Warning: Severe Bleeding and Thrombosis Complications

5.1 Hypersensitivity Reactions

  • Allergic...
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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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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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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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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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13 NONCLINICAL TOXICOLOGY

13.2 Animal Toxicology and/or Pharmacology

Thrombin Concentration...

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14 CLINICAL STUDIES

In a randomized, double-blinded, controlled trial that compared recombinant human thrombin to THROMBIN-JMI, 206 patients received THROMBIN-JMI and 205 patients received recombinant human thrombin as...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Not made with natural rubber latex.

THROMBIN-JMI® is supplied in the following packages:

 
NDC 60793-215-05...
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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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