DEFINITY® is an injectable cardiovascular ultrasound enhancement agent comprised of lipid-coated echogenic microbubbles filled with octafluoropropane gas. Administration of DEFINITY® enhances clinicians’ view of the left ventricle of the heart during an echocardiogram to aid with diagnosis.
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DEFINITY® is an ultrasound enhancing agent that improves diagnostic outcomes, patient management and cost-effectiveness2
Used in multiple clinical settings, DEFINITY® has a proven safety profile1,3 and has been used in more than 14 million studies.4
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Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are 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® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG).
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® and DEFINITY® RT administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available.
In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions and/or with pre-existing PEG hypersensitivity [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying conditions.
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.
- 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.
- Data on file, Lantheus Medical Imaging, Inc.,
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