Application Nr Approved Date Route Status External Links
BLA125351 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tachosil Is A Fibrin Sealant Patch Indicated For Use With Manual Compression In Adult And Pediatric Patients As An Adjunct To Hemostasis In Cardiovascular And Hepatic Surgery When Control Of Bleeding By Standard Surgical Techniques (Such As Suture, Ligature Or Cautery) Is Ineffective Or Impractical. Limitations For Use • Tachosil Cannot Safely Or Effectively Be Used In Place Of Sutures Or Other Form Of Mechanical Ligation For The Treatment Of Major Arterial Or Venous Bleeding. • Not For Use In Children Under One Month Of Age. Tachosil Is A Fibrin Sealant Patch Indicated For Use With Manual Compression In Adult And Pediatric Patients As An Adjunct To Hemostasis In Cardiovascular And Hepatic Surgery, When Control Of Bleeding By Standard Surgical Techniques (Such As Suture, Ligature Or Cautery) Is Ineffective Or Impractical. ( 1 ) Limitations For Use Not For Use In Place Of Sutures Or Other Forms Of Mechanical Ligation In Treatment Of Major Arterial Or Venous Bleeding. ( 1 ) Not For Use In Children Under One Month Of Age. ( 8.4 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Fibrinogen Human
2. Human Thrombin

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