Generic Name and Formulations:
Protein C concentrate (human) 500 IU, 1000 IU; per vial; lyophilized pwd for IV inj after reconstitution; contains albumin; preservative-free.
Shire US, Inc.
Indications for CEPROTIN:
Prevention and treatment of venous thrombosis and purpura fulminans. Replacement therapy for pediatric and adult patients.
Adults and Children:
<10kg: max infusion rate 0.2mL/kg/min; ≥10kg: max infusion rate 2mL/min. Individualize. Acute episodes/short term prophylaxis: initially 100–120 IU/kg, then 60–80 IU/kg every 6 hours for 3 doses (adjust dose to maintain target peak protein C activity of 100%); maintenance: 45–60 IU/kg every 6 or every 12 hours (maintain trough protein C level above 25% for duration of therapy); continue until desired anticoagulation achieved. Long-term prophylaxis: 45–60 IU/kg every 12 hours (maintain trough protein C level above 25%). Switching to oral anticoagulants: start with low dose; continue protein C replacement until stable anticoagulation obtained.
Measure protein C activity before and during treatment; if acute thrombotic event occurs, obtain protein C activity measurement before the next injection until patient is stable. Contains human plasma; monitor for possible infection transmission. Mouse protein allergy. Contains heparin; if heparin-induced thrombocytopenia suspected, check platelet counts immediately, consider discontinuing. Renal impairment and/or sodium-restricted (max daily dose contains sodium >200mg). Pregnancy (Cat.C). Nursing mothers.
Increased risk of bleeding with concurrent anticoagulants, tissue plasminogen activator.
Rash, itching, lightheadedness; hypersensitivity reactions (discontinue if occurs); hemothorax, hypotension.
Report all infections suspected to be transmitted by Ceprotin to (866) 888-2472.
Single-use vial—1 (w. diluent, supplies)
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