Cardiovascular Business - November/December 2008 - (Page 10)

WARNING: Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutrencontaining microsphere administration. • Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS). • In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS). • Always have resuscitation equipment and trained personnel readily available. INDICATIONS AND USAGE Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established. IMPORTANT SAFETY INFORMATION Do not administer DEFINITY® to patients with known or suspected cardiac shunts (right-to-left, bi-directional or transient right-to-left), or hypersensitivity to perflutren. Do not administer DEFINITY® by intra-arterial injection. 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). 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 the absence of these underlying conditions, observe patients closely during and following DEFINITY® administration. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY® administration and monitor all patients for acute reactions. Please See Brief Summary Including Boxed WARNING Regarding Serious Cardiopulmonary Reactions on the next page. DEFINITY and VIALMIX are registered trademarks of Lantheus Medical Imaging, Inc. © 2008 Lantheus Medical Imaging, Inc. All rights reserved. Printed in USA. T6-K0022 June 2008

Table of Contents Feed for the Digital Edition of Cardiovascular Business - November/December 2008

Cardiovascular Business - November/December 2008 Contents First Word Cover Story: Practice Management Software Moves Beyond Bean Counting The Death of CME as We Know It? Clinical Study Digets: Triple-Antiplatelet Therapy; Ex-Vioxx Users Beware Shockwaves Subside from the FDA's Echo Contract Warning Burning Question: Does Laser Heart Therapy for Angina Really Work? Advanced Visualization Adds New Practive Dimension Coronary Calcium Scoring Program Reaps Dividends Interventionalists Get Pumped Up About Mechanical Chest Compression Trials Force Physicians to Re-Examine Oral Anti-Diabetic Drug Protocols News & Views Calendar Reader Resources The ACC Corner

Cardiovascular Business - November/December 2008

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