Prothrombin complex concentrate (Beriplex P/N).

Beriplex P/N, a prothrombin complex concentrate derived from pooled human plasma, contains the vitamin K-dependent coagulation factors II, VII, IX and X, and the vitamin K-dependent coagulation inhibition proteins C and S. Intravenous Beriplex P/N provided rapid and sustained normalization of elevated international normalized ratios and controlled bleeding in adult patients participating in several prospective, noncomparative clinical studies (n = 8-43), with these data supported by clinical experience during its use over more than a decade. Based on extensive clinical experience, Beriplex P/N is also effective in the treatment of congenital deficiency of any of the vitamin K-dependent coagulation factors when purified specific coagulation factor products are not available. Over a decade of clinical experience and more limited data from clinical studies have shown that intravenous infusions of Beriplex P/N were generally well tolerated in adult patients with acquired or congenital deficiencies of the vitamin K-dependent coagulation factors. To date, there have been no proven cases of viral transmission reported in any published studies.