Plasma Safety

CEPROTIN [Protein C Concentrate (Human)] is made from human plasma (the liquid part of blood) which is subjected to many safety steps to reduce the risk of viral infection. CEPROTIN therapy 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.

Donor Selection

Human plasma is collected from carefully selected donors at FDA-approved blood establishments and screened for certain viral infections.

Processing

The risk of transmission of an infectious agent has been reduced by the following processing steps:

Learn more about plasma safety from the Plasma Protein Therapeutics Association

Indications and Usage

CEPROTIN [Protein C Concentrate (Human)] is used for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis (blood clot in the vein), and purpura fulminans (blood spots, bruising and discoloring to skin as a result of clotting of small blood vessels in the skin). CEPROTIN is indicated as a replacement therapy for pediatric and adult patients.

Important Risk Information

CEPROTIN contains small amounts of heparin and/or mouse protein as a result of the manufacturing process. If you are known to have allergic-type reactions (rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and low blood pressure) to mouse protein or to heparin, you should talk to your doctor before using this product. If you experience a severe allergic reaction, including difficulty breathing and (near) fainting while being treated with CEPROTIN, you should stop administration of CEPROTIN and quickly seek emergency treatment.

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.

CEPROTIN contains trace amounts of heparin that may lead to Heparin-induced Thrombocytopenia (a low platelet count which could result in increased bleeding).

Patients on a low salt diet or who have kidney problems should be aware that the quantity of salt in the maximum daily dose of CEPROTIN exceeds 200 mg.

The most serious and common side effects to CEPROTIN observed in clinical trials were rash, itching and lightheadedness.

There have also been individual reports, after the drug was approved, of bleeding into the chest, very low blood pressure, fever, restlessness and increased sweating.

Please review the CEPROTIN Prescribing Information for full prescribing details.

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