Hemostasis in patients suffering from hemophilia with inhibitor has been managed with activated prothrombin complex concentrates (APCCs) or recombinant activated blood coagulation factor VII (rFVIIa). However, neither of these agents are satisfactory in view of safety for the former agents and in view of efficacy for the latter agents. To obviate these disadvantages, the present inventors disclosed in Japanese Patent Publication No. 2001-181204 (Japanese Patent Application No. 368122/1999) that a pharmaceutical composition comprising FVIIa and FX is useful as a hemostatic.
A pharmaceutical composition comprising as an active ingredient proteins for hemostatic management is most suitably administered intravenously in a dosage form appropriate for application via a container such as an ampoule, a syringe or a vial in which the composition is contained. More generally, a set of two containers has been used, one containing lyophilized proteins and the other containing a solution for dissolving said lyophilized proteins. A concentrate of proteins relating to blood coagulation factors, said proteins being prepared from plasma or by using the genetic recombination technique, has been formulated to a pharmaceutical preparation wherein most of said preparation has been provided as a set of lyophilized powder of proteins and a dissolving solution.