THROMBIN HUMAN and FIBRINOGEN
THROMBIN HUMAN and FIBRINOGEN is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including TachoSil. Available dosage form: patch.
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
- HUMAN THROMBIN, FIBRINOGEN HUMAN
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 )