1. 藥品名稱： 組織修復凝合劑 第二代

1 1. ( ) / tisseel Solution for sealant : 000925 2. 1. tisseel tisseel Human fibrinogen (as Clottable Protein) 72-110 mg1 Human Factor XIII 10 IU Aprotinin (bovine) 3000 KIU2 (Excipient): Polysorbate 80 mg/ml 2: Thrombin Human thrombin 500 IU3 Calcium chloride 40 mol ( mg) 1.

2 Protein 96-125mg/ml 2. 1 EPU 1800 KIU (Kallidogenase Inactivator Units) 3. Thrombin WHO Thrombin 3. 4. ( ) tisseel tisseel 4 20 (ml) 2ml ISSEEL 10 ( 1 tisseel 1 Thrombin ) tisseel tisseel (CABG)

3 FIBRIN SEALANT VH S/D tisseel tisseel (fibrin clot) (aprotinin) (aprotinin) (aprotinin) (aprotinin) (aprotinin) 80 (Polysorbate 80) ( ) tisseel Thrombin / (HIV) B (HBV) C (HCV) A (HAV) Parvovirus B19 Parvovirus B19 ( ) ( ) (.)

4 / (aprotinin) ( ) (aprotinin) (DIC) ( ) 157 tisseel 2 (fibrin D-dimer) D-dimers 79 tisseel (13 ) (4 ) ( ) tisseel ( ) (post-procedural pain)

5 2 1 53 tisseel / 2/157 1/79 1/79 2/79 1/79 4/79 2/79 13/79 1/79 1/79 2/79 1/79 1/79 5. (ATC Code) B02BC (ATC Code) V03AK (fibrinogen) (fibrin) (monomer) (fibrinopeptides) (fibrinogen) (fibrin) XIIIa (thrombin) (concerted action) XIII XIIIa (plasmin) (fibrinolytic activity) (aprotinin) tisseel 317 tisseel ( )

6 5 tisseel ( ) ( ) 5 tisseel ( ) Fibrin sealant ( ) 127/144( ) 129/144( ) 108/123( ) 122/135( ) tisseel tisseel tisseel (fibrinolysis) (phagocytosis) tisseel ( ) ( ) tisseel tisseel (Mutagenicity) tisseel (positive) (sealer protein solution) (in vitro)

7 S/D (Solvent/Detergent) tisseel 6. tisseel (Human albumin) (Histidine) (Niacinamide) (sodium citrate dihydrate) 80 polysorbate 80 (Tween 80) (water for injections) Thrombin (Human albumin) (sodium chloride) (water for injections) tisseel ( 25 C) 72 72 ( -18 C ) tisseel thrombin polypropylene 1ml 2ml 5ml tisseel 1ml 2ml 5ml Thrombin (=DUO set) ( )

8 tisseel 2 4 10 tisseel tisseel OP tisseel Thrombin 33-37 C 37 C 33-37 C 37 C tisseel . (incubator) 33 C 37 C (incubator).

9 33 C 37 C 72 33 C 37 C . 33 C 37 C ( ) 33 C 37 C( ) 2 ml 60 15 4 ml 110 25 10 ml 160 35 tisseel Thrombin tisseel tisseel tisseel Fibrin 72 tisseel ( ) ( ) 2 ml 5 4 ml 5 10 ml 12 ( )

10 2 ml 40 4 ml 85 10 ml 105 tisseel Thrombin (joining piece) (joining piece) tisseel -Thrombin Thrombin (500 IU/ml) 3-5 collagen fleece 7.