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1 Indications And Usage Bivalirudin For Injection Is A Direct Thrombin Inhibitor Indicated For Use As An Anticoagulant In Patients: With Unstable Angina Undergoing Percutaneous Transluminal Coronary Angioplasty (Ptca). ( 1.1 ) Undergoing Percutaneous Coronary Intervention (Pci) With Provisional Use Of Glycoprotein Iib/iiia Inhibitor (Gpi) As In The Replace-2 Study. ( 1.2 ) With, Or At Risk Of, Heparin-Induced Thrombocytopenia (Hit) Or Heparin-Induced Thrombocytopenia And Thrombosis Syndrome (Hitts), Undergoing Pci. ( 1.2 ) Bivalirudin For Injection Is Intended For Use With Aspirin. ( 1.3 ) Limitation Of Use Safety And Effectiveness Not Established In Patients With Acute Coronary Syndromes Who Are Not Undergoing Ptca Or Pci. ( 1.4 ) 1.1 Percutaneous Transluminal Coronary Angioplasty (Ptca) Bivalirudin For Injection Is Indicated For Use As An Anticoagulant In Patients With Unstable Angina Undergoing Percutaneous Transluminal Coronary Angioplasty (Ptca). 1.2 Percutaneous Coronary Intervention (Pci) Bivalirudin For Injection With Provisional Use Of Glycoprotein Iib/iiia Inhibitor (Gpi) As Listed In The Replace-2 Trial [See Clinical Studies (14.1) ] Is Indicated For Use As An Anticoagulant In Patients Undergoing Percutaneous Coronary Intervention (Pci). Bivalirudin For Injection Is Indicated For Patients With, Or At Risk Of, Heparin Induced Thrombocytopenia (Hit) Or Heparin Induced Thrombocytopenia And Thrombosis Syndrome (Hitts) Undergoing Pci. 1.3 Use With Aspirin Bivalirudin For Injection In These Indications Is Intended For Use With Aspirin And Has Been Studied Only In Patients Receiving Concomitant Aspirin [See Dosage And Administration (2.1) And Clinical Studies (14.1) ] . 1.4 Limitation Of Use The Safety And Effectiveness Of Bivalirudin For Injection Have Not Been Established In Patients With Acute Coronary Syndromes Who Are Not Undergoing Ptca Or Pci.
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