INDICATIONS AND USAGE3
LUMASON® is an ultrasound contrast agent indicated for use:
in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients
CONTRAINDICATIONS3
LUMASON® is contraindicated in patients with:
history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON
IMPORTANT SAFETY INFORMATION3
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)].
• Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)].
• Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].
The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].3
LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).
LUMASON and SONOVUE are registered trademarks of Bracco Diagnostics Inc. and its affiliated entities.
All other trademarks and registered trademarks are the property of their respective owners.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
