Generic Name and Formulations:
Reteplase 10.4Units (18.1mg); per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Chiesi USA, Inc.
Indications for RETAVASE:
Management of acute myocardial infarction (AMI) to improve ventricular function and to reduce the incidence of congestive heart failure and mortality.
Start as soon as possible after onset of AMI symptoms. 10Units as IV bolus over 2 minutes; repeat dose 30 minutes after initiation of 1st bolus.
Active internal bleeding. History of cerebrovascular accident. Recent intracranial or intraspinal surgery or trauma. Intracranial neoplasm, arteriovenous malformation, or aneurysm. Bleeding diathesis. Severe uncontrolled hypertension.
Avoid noncompressible arterial puncture, internal jugular and subclavian venous punctures, IM inj, nonessential handling of patient to minimize risk of bleeding. Discontinue concomitant anticoagulant therapy if severe bleeding occurs. Recent major surgery. Cerebrovascular disease. GI or GU bleeding. Hypertension. Left heart thrombus. Acute pericarditis. Subacute bacterial endocarditis. Hemostatic defects. Severe hepatic or renal dysfunction. Hemorrhagic ophthalmic conditions. Septic thrombophlebitis. Occluded AV cannula. Elderly. Pregnancy (Cat.C). Nursing mothers.
Bleeding risks increased with heparin, vitamin K antagonists, aspirin, dipyridamole, abciximab. Coagulation tests may be unreliable during therapy.
Tissue plasminogen activator (tPA).
Bleeding, hypersensitivity reactions, GI upset, hypotension, fever; cardiogenic shock, arrhythmias, AV block, pulmonary edema, heart failure, cardiac arrest, ischemia, reinfarction, myocardial rupture, mitral regurgitation, pericardial effusion, pericarditis, cardiac tamponade, venous thrombosis, cholesterol embolism, electromechanical dissociation.
Kit—1 (2 vials w. diluents, supplies)
Half-Kit—1 (1 vial w. diluent)