Lumason® (sulfur hexafluoride lipid-type A microspheres)

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JUSTESA IMAGEN ARGENTINA, S.A.

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Sistemas Medicos, LTDA.

Apartado Aereo 24456
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Fax +571-222-5310

www.sistemasmedicos.com.co

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REIMED, SCRL

Pasaje Villaran 192-194 U-12
Urb. Los Sauces Surquillo
Lima 15076
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ph. 511-448-1087

Fax 511-448-3447

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Lifenir S.A.

Justicia 2069
C 11800 Montevideo
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ph. +5982-400-3020

Fax +5982-4007320

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SUFOMECA

Torre Polar Oeste
Plaza Venezuela
Floor 7, Room 7C
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PO Box 1050
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ph. +582-12-793-3222

Fax +582-12-781-1923

www.sufomeca.com/

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MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

www.mark-medical.com

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EWOPHARMA AG

73 Persenk Street
App. 27 - Floor 8
1164 Sofia
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ph. +359 29624478

Fax +359 28683968

www.ewopharma.com

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MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

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LERIVA IMAGING S.A.

33 Pigis Avenue &
6 Anapiron Polemou Street
151 27 Melissia
Athens (Greece)

ph. +30 210-6199886

Fax +30 210 61 78 733

www.leriva.com/

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EWOPHARMA REPRESENTATION OFFICE

Budakeszi ut 73/F
H-1021 Budapest
(Hungary)

ph. +36 12004650

Fax +36 13980316

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Suratek Ltd

Concordia Place
Triq Il-Halel
Bugibba SPB2529
Malta

ph. +356 2713 1624

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EWOPHARMA A.G. ROMANIA

B-dul Primaverii 19 -21
Sc. B - Et.1 - Sect. 1
011972 - Bucharest
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ph. +40 212601344

Fax +40 212029327

www.ewopharma.com

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Serbia

MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

www.mark-medical.com

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MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

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Caroga Pharma PVT. Ltd

P.O.Box 12627
Addis Abeba
(Ethiopia)

ph. +251 11 4654944 / 11 4161090

Fax +251 11 4654595

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Cyndex Pharmacy

P.O.Box DS 1165 Dansoman
Accra
(Ghana)

ph. +233 21553370

Fax +233-244366622 / 21850072

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DEXCEL

Or-Akiva 30600
30600000 Israel
(Israel)

ph. +972-4-6364015

Fax +972-4-6364004

www.dexcel.com/

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THE ARAB DRUG STORE

Khaleel Al Salem street
Amman
(Jordan)

ph. +962 6 5502995

Fax +962 6 5502984

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Nairobi X-Rays Supplies Ltd.

P.O. Box 41669
Nairobi
(Kenya)

ph. +254 20446265-6-7-8

Fax +254 20 4448515/17

Lebanon

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Lebanon

Unione Pharmaceutic. d'Orient

Rue du Musée Imm. Stephan QtrBadaro
Beyrouth
(Lebanon)

ph. +961 1 396085-6

Fax +961 1 396047

Mauritius

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Mauritius

The Mauritius Pharmacy

4, Louis Pasteur Str Forest Side
(Mauritius)

ph. +230 6762435

Fax +230 675 1387

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Saudi Arabia

SARABEEL COMMERCIAL EST.

Medical Division
P.O. BOX 14795
21434 Jeddah
(Saudi Arabia)

ph. +966 12657 2246

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AXIM - Head Office Midrand

63 Old Pretoria Road
Halfway House Ext 2
Midrand
1685
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ph. +27 113140140

Fax +27 113140141

Uganda

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Uganda

Kampala X-Rays Suppliers

Plot 181 Bombo Rd (KuBbiri)
P.O. Box 9519
Kampala
(Uganda)

ph. +256 41 534313

Fax +256 41 349919

Ukraine

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Ukraine

DELTA MEDlCAL

Delta Medical Promotions AG Representative Office
43 Chernovola Street
08132 Vyshneve, Kyiv region
Ukraine

ph. +38 445933355

http://www.deltamedical.com.ua

United Arab Emirates

Local distributor

United Arab Emirates

MANARA HEALTHCARE

Concord Tower, 6th Floor
Dubai Media City
PO Box 213593, Dubai
United Arab Emirates

ph. +971 4 454 9712

Fax 971 4 454 2310

info@manarahc.com

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Australia

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Australia

REGIONAL HEALTH CARE GROUP

3-11 Primrose Avenue Rosebery
NSW 2018 - Sydney
(Australia)

ph. +61 296624144

Fax +61 296626040

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Hong Kong

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Imaging Products (India ) Ltd

Mumbai
(India)

ph. +91 9819725471

Fax +91 2228320208

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PT DIPA PHARMALAB INTERSAINS

Jl. Panjang No. 10
Kebon Jeruk
Jakarta 11530
(Indonesia)

ph. +62 215348644

Fax +62 2153676066

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REGIONAL HEALTH LIMITED

19C Orbit Drive
Mairangi Bay
(New Zealand)

ph. +64 94140040

Fax +64 94140041

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Pakistan

S. EJAZUDDIN & CO LTD

PO Box 5629 - Zia Plaza
Altaf Hussain Road
74000 Karachi
(Pakistan)

ph. +92 21212032

Fax +92 212629716

Philippines

Local distributor

Philippines

NEW MARKETLINK INTERNATIONAL CORP

Tao Corporate Centre 2291
Don Chino Roches Ave
Ext Makati City Metro
Manila (Philippines)

ph. (632) 836-5838

Singapore

Local distributor

Singapore

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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Taiwan

Local distributor

Taiwan

SUPER FORTUNE ENTERPRISE CO LTD

5 F-1 - 42 Sec.1 Ming
Sheng E. Road Jehovah Building
101 Taipei
(Taiwan)

ph. +886 225673456

Fax +886 225319231

Thailand

Local distributor

Thailand

Interpharmacare Co., Ltd.

90 Moo 13 Soi Mahacha
Bangpleeyai
Bangplee
Samutprakarn 10540
(Thailand)

ph. + 66 2 675 9140-2

Fax + 66 2 325 0265

Vietnam

Local distributor

Vietnam

HOANG GIA INVESCO, JSC

No 74-76 Hoa Bang Str
Cau Giay
Dist Ha Noi Hanoi
(Viet Nam)

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