Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
PROTEIN C (UNII: 3Z6S89TXPW) (PROTEIN C - UNII:3Z6S89TXPW)
Baxalta US Inc
PROTEIN C
PROTEIN C 100 [iU] in 1 mL
PRESCRIPTION DRUG
Biologic Licensing Application
CEPROTIN- PROTEIN C CONCENTRATE HUMAN BAXALTA US INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEPROTIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPROTIN. CEPROTIN [PROTEIN C CONCENTRATE (HUMAN)] LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION INITIAL U.S. APPROVAL: 2010 INDICATIONS AND USAGE CEPROTIN 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. _(1.1)_ DOSAGE AND ADMINISTRATION INITIATE TREATMENT UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN USING COAGULATION FACTORS/INHIBITORS WHERE MONITORING OF PROTEIN C ACTIVITY IS FEASIBLE. _(2.1)_ NA = Not applicable; Q = every. * † ‡ CEPROTIN DOSING SCHEDULE FOR ACUTE EPISODES, SHORT-TERM PROPHYLAXIS AND LONG-TERM PROPHYLAXIS INITIAL DOSE SUBSEQUENT 3 DO SE S MAINTENANCE DO SE Acute Episode / Short-term Prophylaxis 100-120 IU/kg 60 - 80 IU/kg Q 6 hours 45 - 60 IU/kg Q 6 or 12 hours Long-term Prophylaxis NA NA 45 - 60 IU/kg Q 12 hours Store at 2°C – 8°C (36°F-46°F) and protect from light. Avoid freezing. Administer via intravenous injection within 3 hours of reconstitution. _(16)_ DOSAGE FORMS AND STRENGTHS Blue Bar: Approximately 500 IU/vial _(3)_ Green Bar: Approximately 1000 IU/vial _(3)_ Each single-dose vial contains the following excipients: 8 mg/mL human albumin, 4.4 mg/mL trisodium citrate dihydrate and 8.8 mg/mL sodium chloride when reconstituted with the appropriate amount of diluent. _(3)_ CONTRAINDICATIONS None. _(4)_ 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 hepa Olvassa el a teljes dokumentumot