Discontinue use in occurrence of early symptoms & signs of hypersensitivity reaction, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia & anaphylaxis. Closely monitor previously untreated patients between 10th & 12th exposure day for possible anaphylaxis. Closely observe for signs & symptoms of acute hypersensitivity in patients known to have major deletion mutations of factor IX gene. Not for treatment of factor II, VII & X deficiencies; reversal of coumarin anticoagulant-induced hemorrhage; hemophilia A patients w/ factor VIII inhibitors. Made from pooled human plasma; may carry a risk of transmitting infectious agents, eg, viruses & Creutzfeldt-Jakob disease agent. Closely observe for signs or symptoms of potential disseminated intravascular coagulation in surgery patients & individuals w/ known liver disease. Do not administer at an infusion rate >10 mL/min. Sero-negative pregnant women, or immunocompromised individuals may be seriously affected by parvovirus B19 or HAV. Pregnancy. Childn ≤16 yr.
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