THROMBIN HUMAN and FIBRINOGEN

FDA Drug Profile — TachoSil

Drug Details

Generic Name
THROMBIN HUMAN and FIBRINOGEN
Brand Names
TachoSil
Application Number
BLA125351
Sponsor
Corza Medical GmbH
NDC Codes
3
Dosage Forms
PATCH
Routes
TOPICAL
Active Ingredients
FIBRINOGEN HUMAN, HUMAN THROMBIN

Indications and Usage

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 )