The present application generally relates to methods for preventing or treating bleeding and / or coagulation in individuals in need of preventing or treating bleeding and / or coagulation, and compositions for use in such methods. Such methods include FVa, preferably APC resistant FVa (such as Super FVa), alone or FVIIa, preferably rhFVIIa (NovoSeven® or another FVIIa with increased activity or increased half-life, etc. ) In combination with. When administered in combination, FVa and FVIIa may be used in subjects in need of treating or preventing bleeding or hypocoagulability, such as genetic disorders such as hemophilia or acquired bleeding disorders or hemorrhagic stroke or bleeding Subjects suffering from bleeding or other conditions related to hypocoagulability such as sexual shock, trauma, surgery or dysmenorrhea, or individuals who produce inhibitory antibodies against a procoagulant such as FVIII or FIX, or directly In individuals who have been administered excessive amounts of anticoagulants such as Xa or direct thrombin inhibitors or novel oral anticoagulants (NOACs), or individuals who have demonstrated unexplained bleeding Inducing synergistic benefits when used to treat or prevent bleeding or coagulation. The invention also relates to APC and other anticoagulant therapy as a result of, for example, overproduction of APC (such as through severe injury and / or hemorrhagic shock) or APC or other anticoagulant therapy in the treatment of inflammatory disorders or septic diseases. It relates to super FVa alone or in combination with FVIIa or other coagulants or hemostatic support agents to prevent, treat or reverse the associated bleeding. [Selection] Figure 1本出願は概して、出血及び／または凝固性低下を予防または治療する必要のある個体における出血及び／または凝固性低下の予防方法または治療方法、ならびにこのような方法における使用のための組成物に関する。当該方法は、ＦＶａ、好ましくはＡＰＣ耐性ＦＶａ（スーパーＦＶａなど）の、単独でのまたはＦＶＩＩａ、好ましくはｒｈＦＶＩＩａ（ＮｏｖｏＳｅｖｅｎ（登録商標）または活性の高くなったもしくは半減期の長くなった別のＦＶＩＩａなど）との併用での投与を含む。併用投与する場合、ＦＶａ及びＦＶＩＩａは、出血または凝固性低下を治療または予防することを必要とする対象、例えば、血友病のような遺伝的障害あるいは後天性出血性障害あるい
