Description
Manufacturer
Takeda Manufacturing Austria AG(AUSTRIA)
Registraction Number
MAL15045084AZ
Here’s a detailed overview of TISSEEL [Fibrin Sealant] Frozen Solution:
Content
Active Ingredients:
Fibrinogen (human origin).
Thrombin (human origin).
Aprotinin (synthetic protease inhibitor).
Calcium chloride.
Excipients: Includes stabilizing agents like albumin (human), sodium chloride, and water for injections.
Indications
Hemostasis: Used as an adjunct to control bleeding during surgery when conventional techniques (e.g., sutures, ligatures) are ineffective or impractical.
Sealing: Helps prevent leakage from surgical sites, such as colonic anastomoses, following specific procedures.
Instructions
Dosage:
The amount applied depends on the size of the surgical area and the extent of bleeding.
Administration:
For topical use only; do not inject.
The solution is applied using a spray or dripping method, ensuring a thin, even layer over the target area.
The frozen solution must be thawed and warmed to 37°C before use.
Precautions:
Avoid use in patients with known hypersensitivity to aprotinin.
Not suitable for treating severe arterial or venous bleeding.
Ensure proper application distance to avoid complications like gas embolism.
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