Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1. Pharmacodynamic Properties

Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30    Mechanism of action
The fibrin adhesion system initiates 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 activated from Factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both, the conversion of fibrinogen and the crosslinking of fibrin. As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Clinical efficacy and safety
Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL,72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra-abdominal surgery.
The efficacy of EVICEL for suture line sealing in dura mater closure was demonstrated in 139 patients (89 treated with EVICEL and 50 controls) undergoing craniotomy/craniectomy procedures.


Paediatric population
Limited paediatric data are available to support efficacy and safety of EVICEL in this population. Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included in the controlled study of EVICEL, 4 paediatric patients were treated with EVICEL. Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years. In addition, a paediatric controlled clinical study evaluating the safety and effectiveness of EVICEL as an adjunct to haemostasis in soft tissue or parenchymal organ bleeding was conducted in 40 patients (20 treated with EVICEL and 20 controls). The patients age range was from 11 months to 17 years. Data from this study were consistent with results from the previous study in retroperitoneal and intra-abdominal surgery where non-inferior haemostatic efficacy of EVICEL was demonstrated.

Pharmacokinetic Properties