FDA label 926914a9-78b2-40ea-b37d-2a55c09bf275

5 WARNINGS AND PRECAUTIONS Discontinue administration if symptoms of hypersensitivity/allergic reactions occur. ( 2.1 , 5.1 , 6.1 ) Made from pooled human plasma. The possibility of transmitting infectious agents cannot be ruled out. ( 5.2 , 11 ) Simultaneous administration with tPA and/or anticoagulants may increase risk of bleeding. ( 5.3 ) Contains heparin. If heparin-induced thrombocytopenia is suspected, check platelet counts immediately and discontinue administration. ( 5.4 ) Contains sodium >200 mg. Patients on a low sodium diet and/or patients with renal impairment should be informed. ( 5.5 ) 5.1 Hypersensitivity / Allergic Reactions CEPROTIN may contain traces of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, discontinue the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment are to be observed. 5.2 Transmission of Infectious Agents CEPROTIN is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing a broad range of viruses during manufacture. See DESCRIPTION (11) . Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at 1-866-888-2472. The physician should discuss the risks and benefits of this product with the patient. Some viruses, such as Human Parvovirus B19 (B19V) or Hepatitis A, are particularly difficult to remove or inactivate. B19V most seriously affects pregnant women (fetal infection), or immune-compromised individuals. Symptoms of B19V infection include fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of Hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear. Appropriate vaccination (hepatitis A and B) should be considered for patients in regular and/or repeated receipt of human plasma-derived Protein C. 5.3 Bleeding Episodes Several bleeding episodes have been observed in clinical studies. Concurrent anticoagulant medication may have been responsible for these bleeding episodes. However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events. Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA. 5.4 Heparin-induced Thrombocytopenia (HIT) CEPROTIN contains trace amounts of heparin which may lead to Heparin-induced Thrombocytopenia. The platelet count should be determined immediately and discontinuation of CEPROTIN should be considered. 5.5 Low Sodium Diet / Renal Impairment Patients on a low sodium diet should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Patients with renal impairment should be monitored more closely for sodium overload.

6 ADVERSE REACTIONS The most serious and common adverse reactions observed in clinical trials were rash, itching and lightheadedness. ( 2.1 , 5.1 , 6.1 ) The most serious adverse reactions postmarketing were hemothorax and hypotension. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience The most serious and common adverse reactions related to CEPROTIN treatment observed were hypersensitivity or allergic reactions (itching and rash) and lightheadedness . Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in one clinical study of a drug cannot be directly compared with rates in the clinical studies of the same drug or another drug and may not reflect the rates observed in practice. The safety profile of CEPROTIN was based on 121 patients from clinical studies and compassionate use in severe congenital Protein C deficiency. Duration of exposure ranged from 1 day to 8 years. One patient experienced hypersensitivity/allergic reactions (itching and rash) and lightheadedness which were determined by the investigator to be related to CEPROTIN. No inhibiting antibodies to CEPROTIN have been observed in clinical studies. However, the potential for developing antibodies cannot be ruled out. 6.2 Post-marketing Experience The following adverse reactions have been identified during postapproval use of CEPROTIN: hemothorax, hypotension, hyperhydrosis, fever and restlessness. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.