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Optison (Albumin Human) - Summary

 
 



WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration (see WARNINGS and PRECAUTIONS).

  • Assess all patients for the presence of any condition that precludes OPTISON administration (see CONTRAINDICATIONS).
  • Always have resuscitation equipment and trained personnel readily available.
 

OPTISON SUMMARY

OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is a sterile non-pyrogenic suspension of microspheres of human serum albumin with perflutren for contrast enhancement during the indicated ultrasound imaging procedures. The vial contains a clear liquid lower layer and a white upper layer that, after resuspension by gentle mixing, provides a homogeneous, opaque, milky-white suspension for intravenous injection.

OPTISON is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.


See all Optison indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Optison (Albumin Human)

FDA Panel Divided Over Diagnostic HbA1c Test
Source: MedPageToday.com - medical news plus CME for physicians [2016.07.22]
(MedPage Today) -- Called generally safe and accurate, but panel questions future of use

Medical News Today: 'Smart thread' enables 3-D tissue embedding for medical diagnostics
Source: Featured Health News from Medical News Today [2016.07.21]
Researchers have embedded thread-based microfluidic networks with sensors inside 3-D tissue to measure tissue properties and transmit them wirelessly.

'Smart thread' enables 3-D tissue embedding for medical diagnostics
Source: Medical Devices / Diagnostics News From Medical News Today [2016.07.21]
Researchers have embedded thread-based microfluidic networks with sensors inside 3-D tissue to measure tissue properties and transmit them wirelessly.

Zika virus: Antibodies identified with therapeutic and diagnostic potential
Source: Immune System / Vaccines News From Medical News Today [2016.07.18]
A team of researchers from the Institute for Research in Biomedicine (IRB, USI UniversitĂ  della Svizzera italiana) and the Swiss biotech company Humabs BioMed SA has identified novel therapeutic...

5th Semi-Annual Medical Device & Diagnostic Labeling Conference, September 29-30, 2016, Phoenix
Source: Conferences News From Medical News Today [2016.07.05]
As medical device and diagnostic manufacturers continue to develop life enhancing products for patients across the globe, medical product labels hold an increasingly important position in providing...

more news >>

Published Studies Related to Optison (Albumin Human)

Glycated albumin predicts the effect of dual and single antiplatelet therapy on recurrent stroke. [2015]
recurrence of stroke in patients on either dual or single antiplatelet therapy... CONCLUSIONS: GA could be a potential biomarker to predict the effects of dual and

Effects of combined lipoic acid and pyridoxine on albuminuria, advanced glycation end-products, and blood pressure in diabetic nephropathy. [2013]
This study was designed to investigate the effects of combined administration of lipoic acid and pyridoxine on albuminuria, oxidative stress, blood pressure, serum advanced glycation end-products, nitric oxide (NO), and endothelin-1 in patients with diabetic nephropathy.

High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. [2013]
proportion of patients with a favourable outcome... INTERPRETATION: Our findings show no clinical benefit of 25% albumin in patients

Albumin resuscitation for traumatic brain injury: is intracranial hypertension the cause of increased mortality? [2013]
Mortality is higher in patients with traumatic brain injury (TBI) resuscitated with albumin compared with saline, but the mechanism for increased mortality is unknown...

Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. [2011.07]
CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatinine ratio is independently associated with HbA1c and NT-proBNP, even in non-diabetic patients.

more studies >>

Clinical Trials Related to Optison (Albumin Human)

CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children [Recruiting]
In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. [Completed]
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Regadenoson Real Time Perfusion Imaging Trial-Optison [Recruiting]
The purpose if this study is to examine how effective Regadenoson is in detecting coronary artery disease during a stress echocardiogram when Optison is administered. Optison is a contrast agent that improves the images of the heart on the echocardiogram (echo) machine. Optison is approved by the Food and Drug Administration (FDA) to use during stress echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is used to chemically increase the heart rate and is approved for nuclear imaging tests. Regadenoson is a FDA approved drug but not for the intended use in this study.

Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease [Terminated]

The purpose of this study is to find the optimal dose from 3 different dose levels - 0. 15

mL, 0. 5 mL and 1. 5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.

Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). [Completed]

more trials >>


Page last updated: 2016-07-22

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