|Manufacturer:||GE Healthcare Inc.|
Distributed byGE Healthcare Inc.Princeton, NJ 08540Manufactured byMallinckrodt Inc.St.Louis, MO 63042OPTISON™ is a trademark of GE Healthcare.GE and the GE Monogram are trademarks of General Electric Company.ALBUNEX® is a trademark of Mallinckrodt Inc.© 2008 General Electric Company - All rights reserved.Printed in USARevised May 2008OPT-1E
OPTISON is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.The safety and efficacy of OPTISON with exercise stress or pharmacologic stress testing have not been established.
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation).
In these patients, monitor vital signs, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after OPTISON administration.In the absence of these underlying conditions, observe patients closely during and following OPTISON administration.In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS).Always have cardiopulmonary resuscitation personnel and equipment readily available prior to OPTISON administration and monitor all patients for acute reactions.