Eculizumab, a humanized monoclonal antibody against C5 that inhibits terminal complement activation, showed activity in a preliminary 12-week open-label trial in a small cohort of patients with paroxysmal nocturnal hemoglobinuria (PNH). The present study examined whether chronic eculizumab therapy could reduce intravascular hemolysis, stabilize hemoglobin levels, reduce transfusion requirements, and improve quality of life in a double-blind, randomized, placebo-controlled, multi-center global Phase III trial. It has been found that eculizumab stabilized hemoglobin levels, decreased the need for transfusions, and improved quality of life in PNH patients via reduced intravascular hemolysis. Chronic eculizumab treatment appears to be a safe and effective therapy for PNH.La presente invención se refiere a una composición farmacéutica para usarse en el tratamiento de un paciente afectado con Hemoglobinuria Paroxística Nocturna (PNH), en donde la composición es una forma de dosis de un solo uso de 300 mg de eculizumab que comprende 30 Ml de una solución estéril de 10 mg de eculizumab/ml, libre de conservadores.
