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Human thrombin

Generic Name
Human thrombin
Brand Names
Artiss, Evarrest, Evicel, Evithrom, Tachosil, Tisseel, Vistaseal
Drug Type
Biotech
CAS Number
9002-04-4
Unique Ingredient Identifier
6K15ABL77G

Overview

Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues. In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line . Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride .

Background

Human thrombin is a sterile solution, pH 6.8-7.2, containing highly purified human thrombin for the activation of clotting. Thrombin is a highly specific serine protease encoded by the F2 gene that transforms soluble fibrinogen into insoluble fibrin. This transformation mimics the final coagulation cascade step which involves the clotting mass that adheres to the wound surface and achieves hemostasis and sealing of open tissues. In particular, while human thrombin products are made from pooled human source plasma, recombinant thrombin is a human coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line . Furthermore, human thrombin is manufactured by chromatographic purification of prothrombin from cryo-poor plasma followed by activation with calcium chloride .

Indication

Human thrombin is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules are accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In combination with fibrinogen, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Associated Conditions

  • Bleeding
  • Suture rupture

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-8701
TOPICAL
2.0 [USP'U] in 1 1
4/13/2022
Corza Medical GmbH
83078-704
TOPICAL
2.0 [USP'U] in 1 1
9/1/2023
Baxter Healthcare Corporation
0338-8702
TOPICAL
2.0 [USP'U] in 1 1
4/13/2022
Baxter Healthcare Corporation
0338-8704
TOPICAL
2.0 [USP'U] in 1 1
4/13/2022
Corza Medical GmbH
83078-701
TOPICAL
2.0 [USP'U] in 1 1
9/1/2023
Corza Medical GmbH
83078-702
TOPICAL
2.0 [USP'U] in 1 1
9/1/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Human Thrombin for External use,Freeze-dried
国药准字S20050092
生物制品
冻干粉
5/14/2020
Human Prothrombin Complex
国药准字S20190034
生物制品
注射剂
4/3/2024
Human Prothrombin Complex
国药准字S10970049
生物制品
注射剂(冻干粉针剂)
4/9/2020
Human Prothrombin Complex
国药准字S10970050
生物制品
注射剂(冻干粉针剂)
4/9/2020
Human Prothrombin Complex
国药准字S20233101
生物制品
注射剂
2/21/2023
Human Prothrombin Complex
国药准字S20083058
生物制品
注射剂
5/14/2020
Human Prothrombin Complex
国药准字S20240021
生物制品
注射剂
5/21/2024
Human Prothrombin Complex
国药准字S20240045
生物制品
注射剂
9/26/2024
Human Prothrombin Complex
国药准字S20233102
生物制品
注射剂
2/21/2023
Human Prothrombin Complex
国药准字S20190035
生物制品
注射剂
4/3/2024

PPB Drug Approvals

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