Development of antibodies to one or more human prothrombin factors may occur rarely. Use associated with thrombosis and may be associated with increased risk of disseminated intravascular coagulation and thromboembolic complications including myocardial infarction, in acquired or congenital factor deficiency (use with caution in myocardial infarction, coronary artery disease, hepatic dysfunction, peri/postoperative patients and neonates). Severe hypersensitivity and anaphylactic reactions may rarely occur. Antithrombin levels should be monitored in patients being treated for bleeding as result of chronic liver disease or liver transplantation. Administration of prothrombin complex concentrate may exacerbate underlying hypercoagulable states in recipients of vitamin K antagonists. Formulation contains heparin. Product of human plasma (may potentially contain infectious agents which could transmit disease). Severe hepatic dysfunction, inadequate absorption of vitamin K (e.g. pancreatic disorders, diarrhea) or vitamin K antagonist therapy or overdose may lead to coagulation factor deficiencies.