TISSEEL, [Fibrin Sealant] Frozen Solution

Manufacturer
Takeda Manufacturing Austria AG(AUSTRIA)

Registraction Number
MAL15045084AZ

Content:

• Sealer Protein Solution: Contains 91 mg/ml Human Fibrinogen (as clottable protein), 0.6-5 IU/ml Human Factor XIII, and 3000 KIU/ml Aprotinin.
• Thrombin Solution: Contains 500 IU/ml Human Thrombin and 40 μmol/ml Calcium Chloride.

• Hemostasis: Used as an adjunct to control bleeding during surgery when conventional techniques are ineffective.
• Sealing: Used to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
• Surgical Applications: Used in various surgical procedures, including plastic surgery, orthopedic surgery, traumatic surgery, and dental surgery.

• Dosage: The amount of TISSEEL used depends on the indication, application method, and number of applications. Typically, 1 ml of Sealer Protein Solution and 1 ml of Thrombin Solution are used per 10 cm² of tissue.
• Administration: Apply topically as a thin layer by dripping or spraying using a cannula or spray set. Ensure the tissue surface is as dry as possible before application.
• Precautions: Do not inject TISSEEL directly into the circulatory system or highly vascularized tissue. Avoid using in individuals with known hypersensitivity to aprotinin. Apply with care in coronary artery bypass surgery due to the risk of inadvertent intravascular application.
• Storage: Store below -18°C (0°F) until ready for use.