MedPath

Thrombin

Generic Name
Thrombin
Brand Names
Thrombin-jmi
Drug Type
Biotech
Unique Ingredient Identifier
25ADE2236L

Overview

Also known as coagulation factor II, thrombin is a serine protease that plays a physiological role in regulating hemostasis and maintaining blood coagulation. Once converted from prothrombin, thrombin converts fibrinogen to fibrin, which, in combination with platelets from the blood, forms a clot. Medical thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin in the presence of calcium chloride. Thrombin requires no intermediate physiological agent for its action. It clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself. Bovine thrombin however, is capable of causing fatal severe bleeding or thrombosis . This thrombosis may result from the development of antibodies against bovine thrombin . Bleeding may result from the development of antibodies against bovine factor V . These antibodies may subsequently cross-react with endogenous human factor V and lead to its deficiency . Patients who are know or suspected to have antibodies to bovine thrombin and/or bovine factor V should not be re-exposed to the product . Patients who are administered bovine thrombin should be monitored for abnormal coagulation laboratory values, bleeding, or indeed, thrombosis . A variety of human thrombin and recombinant thrombin (ie. thrombin alfa) products are available as alternatives to using bovine thrombin.

Indication

Bovine thrombin is a topical 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 (like suture, ligature, or cautery) is ineffective or impractical . Additionally, topical bovine thrombin can also be used in combination with an absorbable gelatin sponge, USP .

Associated Conditions

  • Refractory to surgical techniques Bleeding

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
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Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
THROMBOSTAT 5000UNITS
00023094
Powder For Solution - Topical
5000 UNIT / VIAL
12/31/1951
THROMBOSTAT 1000UNITS
parke-davis division, warner-lambert canada inc.
00023086
Powder - Topical
1000 UNIT / VIAL
12/31/1960
THROMBINAR PWS 5000UNIT/VIAL
Armour Pharmaceutical Co.
00608696
Powder For Solution - Topical
5000 UNIT / VIAL
12/31/1984
THROMBOSTAT 10000UNITS
00023108
Powder - Topical
10000 UNIT / VIAL
12/31/1954

CIMA AEMPS Drug Approvals

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Registration Number
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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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License Number
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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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