Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
BIVALIRUDIN AS TRIFLUOROACETATE
A.L. MEDI-MARKET LTD.
B01AE06
POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION
BIVALIRUDIN AS TRIFLUOROACETATE 250 MG/VIAL
I.V
Required
HAINAN POLY PHARM CO., LTD., , PEOPLE’S REPUBLIC OF CHINA
BIVALIRUDIN
Bivalirudin Medi-Market 250 mg is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
2023-01-12
NAME OF THE MEDICINAL PRODUCT Bivalirudin Medi-Market 250 mg Powder for concentrate for solution for injection/infusion (I.V.) QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg bivalirudin (as trifluoroacetate). For the full list of excipients, see section 11. 1 THERAPEUTIC INDICATIONS Bivalirudin Medi-Market 250 mg is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose Bivalirudin Medi-Market 250 mg has been studied only in patients receiving concomitant aspirin. The recommended dose of bivalirudin Medi-Market 250 mg is an intravenous bolus dose of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h for the duration of the procedure. Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed. Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI). 2.2 Dose Adjustment in Renal Impairment Bolus Dose No reduction in the bolus dose is needed for any degree of renal impairment. Maintenance Infusion In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h. Monitor anticoagulant status in patients with renal impairment. In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h _[see Use in Specific Populations (8.6), Clinical _ _Pharmacology (12.3)]_ . 2.3 Instructions for Preparation and Administration Bivalirudin Medi-Market 250 mg is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. Preparation Instructions for Bolus Injection and Continuous Infusion • To each 250 mg vial, add 5 mL of Sterile Water for Injection. • Pročitajte cijeli dokument