Lumason® (sulfur hexafluoride lipid-type A microspheres)

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EWOPHARMA A.G. ROMANIA

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Caroga Pharma PVT. Ltd

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Unione Pharmaceutic. d'Orient

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A.Medical

Varkalu Str. 13A, Riga
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A.Medical

Varkalu Str. 13A, Riga
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The Mauritius Pharmacy

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AXIM - Head Office Midrand

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Kampala X-Rays Suppliers

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MANARA HEALTHCARE

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REGIONAL HEALTH CARE GROUP

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SUPER FORTUNE ENTERPRISE CO LTD

5 F-1 - 42 Sec.1 Ming
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Fax +886 225319231

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Imaging Products (India) Ltd

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PT DIPA PHARMALAB INTERSAINS

Jl. Panjang No. 10
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REGIONAL HEALTH LIMITED

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S. EJAZUDDIN & CO LTD

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NEW MARKETLINK INTERNATIONAL CORP

Tao Corporate Centre 2291
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LF ASIA PHARMACEUTICAL DIVISION

Healthcare Distribution Centre
24 Penjuru Road (off Penjuru Close)
#03-04 CWT Commodity Hub
(Singapore 609128)

ph. +65 65097629

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Interpharmacare Co., Ltd.

90 Moo 13 Soi Mahacha
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Bangplee
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ph. + 66 2 675 9140-2

Fax + 66 2 325 0265

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HOANG GIA INVESCO, JSC

No 74-76 Hoa Bang Str
Cau Giay
Dist Ha Noi Hanoi
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ph. +43 7846952

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LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use

LUMASON Press Releases:

Bracco Diagnostics Inc.'s LUMASON^® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, receives U.S. Food and Drug Administration approval for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux

The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON^®
(sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, in patients with cardiac shunts

The Centers for Medicare & Medicaid Services (CMS) Approved Coverage and Coding for Abdominal Ultrasound with Contrast Under the Hospital Outpatient Prospective Payment System (HOPPS) Effective October 1, 2016

Bracco Diagnostics Inc. Receives Innovative Technology Designation from Vizient for LUMASON^® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension for Contrast Echocardiography Designation recognizes the development of new solutions that benefit the healthcare industry

First Approval by U.S. Food and Drug Administration for Contrast Enhanced Ultrasonography of the Liver Received by Bracco Diagnostics Inc. for LUMASON^® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use

The Centers for Medicare & Medicaid Approved Bracco Diagnostics Inc Ultrasound Contrast Agent, Lumason^® (Sulfur Hexafluoride Lipid-Type A microspheres) for injectable Suspension, for Reimbursement, Under the Hospital Outpatient Prospective Payment System

Bracco Diagnostics Inc. and Amerinet announce Group Purchasing Agreement to include LUMASON^TM (sulfur hexafluoride lipid-type A microspheres) for injectable suspension for contrast echocardiography

Bracco Imaging Announces the First Echocardiography Imaging Procedure in U.S. with Lumason^TM (sulfur hexafluoride lipid-type A microspheres) for injectable suspension

Bracco Diagnostics Inc. receives U.S. FDA Approval for new Ultrasound Contrast Agent

LUMASON^® Prescribing Information (PDF)

Download LUMASON^® Safety Data Sheet (PDF)

INDICATIONS AND USAGE ¹
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

CONTRAINDICATIONS ¹
LUMASON is contraindicated in patients with:

history of hypersensitivity reactions of sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

IMPORTANT SAFETY INFORMATION ¹

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)].

Please see full Prescribing Information for LUMASON including boxed WARNING by clicking here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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 is a registered trademark of Bracco Diagnostics Inc.
SonoVue is a registered trademark of Bracco Suisse S.A.

^1. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Monroe Township, NJ: Bracco Diagnostics Inc., December 2016.

Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Phone: 609-514-2200
Toll Free: 1-877-272-2269 (U.S. only)
Fax: 609-514-2446