Indication and Important Safety Information

WARNINGS and PRECAUTIONS
  • Hypersensitivity/Allergic reactionsCEPROTIN® [Protein C Concentrate (Human)] may contain trace amounts 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. In case of hypersensitivity/allergic reaction, discontinue CEPROTIN administration immediately and institute appropriate treatment.
  • Transmission of infectious agentsCEPROTIN is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Bleeding episodesSeveral bleeding episodes have been observed in clinical studies. Concurrent anticoagulant medication may have been responsible for these bleeding episodes. CEPROTIN administration may have further contributed to these bleeding events. Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.
  • Heparin-induced thrombocytopenia (HIT)CEPROTIN contains trace amounts of heparin that may lead to HIT, which can be associated with a rapid decrease of thrombocytes. If HIT is suspected, determine the platelet count immediately and discontinue CEPROTIN administration.
  • Low sodium diet/Renal impairmentPatients on a low sodium diet or who have renal impairment should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Monitor patients with renal impairment closely for sodium overload.
ADVERSE REACTIONS

The common adverse reactions related to CEPROTIN treatment observed in clinical trials were the following hypersensitivity or allergic reactions: lightheadedness, itching and rash.

Indication

CEPROTIN® [Protein C Concentrate (Human)] is indicated for pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans

Please review the CEPROTIN Prescribing Information for full prescribing details.

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