Tisseel Description

The frozen solutions are colorless to pale yellow, opalescent.
After thawing, they are colorless to pale yellow.
Component 1: Sealer protein solution: Human fibrinogen (as clottable protein) 91 mg¹/mL, Aprotinin (synthetic) 3000 KIU²/mL.
Excipient(s) with known effect: Polysorbate 80 0.6-1.9 mg/mL.
Component 2: Thrombin solution: Human thrombin 500 IU³/mL, Calcium chloride dihydrate 40 μmol/mL.
1, 2 or 5 mL sealer protein solution (with synthetic aprotinin) and 1, 2 or 5 mL thrombin solution (with calcium chloride dihydrate) combine to make 2, 4 or 10 mL ready-to-use fibrin sealant solution. (See Table 1.)

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TISSEEL Fibrin Sealant with Synthetic Aprotinin contains Human Factor XIII co-purified with Human Fibrinogen in a range of 0.6-5 IU/mL.
¹ Contained in a total protein concentration of 96-125 mg/mL.
² 1 EPU (European Pharmacopoeia Unit) corresponds to 1800 KIU (Kallidinogenase Inactivator Unit).
³ Thrombin activity was determined using the current WHO Standard for thrombin.
Excipients/Inactive Ingredients: Component 1: Sealer protein solution: Human albumin, L-histidine, Niacinamide, Sodium citrate dihydrate, Polysorbate 80 (Tween 80), Water for Injections.
Component 2: Thrombin solution: Human albumin, Sodium chloride, Water for Injections.