News | November 03, 2011

Lantheus Announces Labeling Changes for Definity Ultrasound Contrast

lantheus definity

November 3, 2011 – Lantheus Medical Imaging announced important changes to the U.S. product label for Definity Vial for (perflutren lipid microsphere) Injectable Suspension. The contrast agent 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.

 After a review of Lantheus’ 2010 application for proposed label changes submitted to the U.S. Food and Drug Administration (FDA), the following revisions have been made to the prescribing information for Definity:

·         Removal of the statement from the boxed warning: “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.” Similar language was also removed from the warning section of the label.

·         Addition of the statement to the boxed warning: Most serious reactions occur within 30 minutes of administration,” which is consistent with the current information in the warning section.

·         Removal of the statement from the product indications and usage section of the label: “The safety and efficacy of Definity with exercise stress or pharmacologic stress testing have not been established.”

·         Addition of the further qualifier in the statement in the warning section: “Serious cardiopulmonary reactions, including fatalities, have occurred ‘uncommonly’ during or following perflutren-containing microsphere administration.”

·         Inclusion of summary data from post-approval CaRES (Contrast echocardiography Registry for Safety Surveillance) safety registry in the post-marketing experience section and from post-approval pulmonary hypertension study in the clinical trials experience section.

For more information: www.definityimaging.com

 

Related Content

Philips Lumify Earns U.S. Army Airworthiness Certification
News | Ultrasound Imaging | May 22, 2019
Philips announced that Philips Lumify, a point-of-care ultrasound device, has earned the U.S. Army Airworthiness...
Clarius Releases Clarius Live Ultrasound Telemedicine Solution
Technology | Ultrasound Imaging | May 15, 2019
Clarius Mobile Health released a telemedicine solution called Clarius Live. The simple-to-use feature allows any...
Ultrasonic Device Safe and Effective for Lung Vessel Sealing in Minimally Invasive Lobectomy
News | Interventional Radiology | May 06, 2019
According to a new study, an ultrasonic vessel-sealing device can improve patient outcomes by reducing the incidence of...
Hong Kong Polytechnic University Develops Palm-sized 3-D Scoliosis Ultrasound Imaging System
News | Ultrasound Imaging | May 03, 2019
The Hong Kong Polytechnic University (PolyU) announced the development of a palm-sized 3-D ultrasound imaging system...
New Guideline Published for Evaluation of Valvular Regurgitation After Catheter-based Valve Interventions
News | Cardiovascular Ultrasound | April 30, 2019
A new document compiled by four cardiac imaging professional societies provides a resource to guide clinicians in best...
Six Predictions on How the Ultrasound Systems Market Will Expand Through 2022
News | Ultrasound Imaging | April 26, 2019
With healthcare costs continuing to rise, affordable and accurate imaging and diagnosis achieved through ultrasound...
ITN Wins Jesse H. Neal Award for Best Technical Content
News | Radiology Business | April 24, 2019
April 24, 2019 — Imaging Technology News (ITN) was recently named the 2019 Jesse H.
Ebit and DiA Imaging Analysis Partner on AI-based Cardiac Ultrasound Analysis
News | Cardiovascular Ultrasound | April 16, 2019
DiA Imaging Analysis has partnered with the Italian healthcare IT company Ebit (Esaote Group), to offer DiA’s LVivo...
360 Photos | 360 View Photos | April 12, 2019
This 360 degree view shows staff at the ...
Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...