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

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Thrombin
国药准字H62020504
化学药品
冻干粉
6/22/2020
Thrombin
国药准字H62020506
化学药品
冻干粉
6/22/2020
Thrombin
国药准字H53021113
化学药品
冻干粉
9/14/2020
Thrombin
国药准字H62020505
化学药品
冻干粉
6/22/2020
Thrombin
国药准字H62020503
化学药品
冻干粉
6/22/2020
Thrombin
国药准字H36021149
化学药品
冻干粉
7/19/2022
Thrombin
国药准字H53021112
化学药品
冻干粉
9/14/2020
Lyophilizing Thrombin Powder
国药准字H36021562
化学药品
冻干粉
7/18/2022
Lyophilizing Thrombin Powder
国药准字H21024035
化学药品
散剂
6/15/2020
Lyophilizing Thrombin Powder
国药准字H21024034
化学药品
散剂
6/15/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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

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