Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1     Pharmacodynamic properties
Pharmacotherapeutic group: local hemostatics combinations, ATC code: B02BC30; tissue adhesives, ATC code: V03AK

The fibrin adhesion system imitates the last phase of physiological blood coagulation.
Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides. The fibrin monomers aggregate and form a fibrin clot. Factor XIIIa, which is generated from Factor XIII by the concerted action of thrombin and calcium ions, stabilizes the clot by the cross-linking of fibrin fibers.

As wound healing progresses increased fibrinolytic activity is induced by plasmin, and decomposition of fibrin to fibrin degradation products is initiated. Proteolytic degradation of fibrin is inhibited by anti-fibrinolytics. Aprotinin is present in TISSEEL FROZEN as an antifibrinolytic to prevent premature degradation of the clot.

To prove the efficacy, in vivo studies with four animal models which imitated the patient situation as closely as possible, were carried out. TISSEEL FROZEN was effective with regard to primary and secondary hemostasis as well as wound healing.

Clinical studies demonstrating hemostasis and suture support were conducted in a total of 213 patients (120 with TISSEEL FROZEN, 93 with control) undergoing vascular surgery with ePTFE conduits, in a total of 70 patients (35 with TISSEEL FROZEN, 35 with control) undergoing partial hepatic resection and in a total of 317 patients (157 with TISSEEL FROZEN, 160 with a predecessor single virus inactivated form of the product as control) undergoing cardiac surgery with a cardiopulmonary bypass and median sternotomy.

Efficacy of TISSEEL FROZEN as an adjunct to conventional surgical methods in sealing colonic anastomoses in trauma patients undergoing closure of temporary colostomies has been demonstrated in a randomized, controlled, prospective, single-center study conducted in 1986 in a total of 120 patients (61 with TISSEEL FROZEN, 59 with control).

Pharmacokinetic Properties

5.2    Pharmacokinetic properties

TISSEEL FROZEN is intended for epilesional use only. Intravascular administration is contraindicated. As a consequence, intravascular pharmacokinetic studies were not performed in man.

Pharmacokinetic studies in different species of laboratory animals were not conducted.

Fibrin sealants/hemostatics are metabolized in the same way as endogenous fibrin by fibrinolysis and phagocytosis.