Important Risk Information

Indications and Usage

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

Important Risk Information

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. Discontinue administration if symptoms of hypersensitivity/allergic reactions occur.

CEPROTIN 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.

Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.

CEPROTIN contains trace amounts of heparin, which may lead to Heparin-induced Thrombocytopenia.

Patients 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.

The most serious and common adverse reactions to CEPROTIN observed in clinical trials were hypersensitivity or allergic reaction (itching and rash) and lightheadedness.

The following adverse reactions have been identified during post approval use of CEPROTIN: hemothorax, hypotension, hyperhydrosis, fever and restlessness.

Please review the CEPROTIN Prescribing Information for full prescribing details.

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