DEFINITY® is an injectable cardiovascular ultrasound contrast agent comprised of lipid-coated echogenic microbubbles filled with octafluoropropane gas that enhances clinicians’ view of the left ventricle of the heart during an echocardiogram to aid with diagnosis.
As a fully synthetic ultrasound contrast agent, DEFINITY® has a proven safety profile1,2 and has been used in more than 7 million echocardiography patients in multiple clinical settings.
DEFINITY® offers a proven diagnostic advantage that optimizes patient management, outcomes and cost-effectiveness4 through:
- small and consistently-sized durable microbubbles1
- extensive safety experience2
- several administration options to meet patient- and practice-specific needs1
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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.
Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes of administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].
- Always have resuscitation equipment and trained personnel readily available.
In postmarketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
|Catalog Number||Product Description|
|DE4||4-Vial Kit US|
|DE16||16-Vial Kit US|
|Accessory Equipment and Materials|
- DEFINITY® [package insert]. N.Billerica, MA. Lantheus Medical Imaging, Inc.,2013.
- Data on file, Lantheus Medical Imaging, Inc.,
- ©2016 Decision Resources, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.
- Kurt M. et al. Impact of Contrast Echocardiography on Evaluation of Ventricular Function and Clinical Management in a Large Prospective Cohort. J Am Coll Cardiol. 2009:53 (19):802-810.