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Argentina

JUSTESA IMAGEN ARGENTINA, S.A.

Viamonte 1328, 9º piso
1053 Buenos Aires
(Argentina)

ph. +5411 4373-0629

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AJOVECO S.A.S.

Cl. 93b #31,
Bogotá
(Colombia)

ph. +57-1-2189-200

www.ajoveco.com.co

Mexico

Perù

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Perù

REIMED, SCRL

Pasaje Villaran 192-194 U-12
Urb. Los Sauces Surquillo
Lima 15076
(Peru)

ph. 511-448-1087

Fax 511-448-3447

United States

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Lifenir S.A.

Justicia 2069
C 11800 Montevideo
(Uruguay)

ph. +5982-400-3020

Fax +5982-4007320

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SUFOMECA

Torre Polar Oeste
Plaza Venezuela
Floor 7, Room 7C
Caracas
PO Box 1050
(Venezuela)

ph. +582-12-793-3222

Fax +582-12-781-1923

www.sufomeca.com/

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Bosnia-Herzegowina

MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

www.mark-medical.com

Bulgaria

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Bulgaria

EWOPHARMA AG

73 Persenk Street
App. 27 - Floor 8
1164 Sofia
(Bulgaria)

ph. +359 29624478

Fax +359 28683968

www.ewopharma.com

Croatia

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Croatia

MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

Greece

Local distributor

Greece

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/

Hungary

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Ungheria

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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Romania

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Romania

EWOPHARMA A.G. ROMANIA

B-dul Primaverii 19 -21
Sc. B - Et.1 - Sect. 1
011972 - Bucharest
(Romania)

ph. +40 212601344

Fax +40 212029327

www.ewopharma.com

Serbia

Local distributor

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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Slovenia

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MARK Srl

Via S. Michele 334
34170 Gorizia - Italy

ph. +39 0481 21711

Fax +39 0481 20719

Eastern Europe, Middle East & Africa

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Estonia

A.Medical

Varkalu Str. 13A, Riga,
LV-1067, Latvia

ph. + 371 67113760

Fax +372 665 18 07

www.amedical.eu

Ethiopia

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Ethiopia

Caroga Pharma PVT. Ltd

P.O.Box 12627
Addis Abeba
(Ethiopia)

ph. +251 11 4654944 / 11 4161090

Fax +251 11 4654595

Ghana

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Ghana

Cyndex Pharmacy

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

ph. +233 244 366622

Fax +233-244366622 / 21850072

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Israel

DEXCEL

Or-Akiva 30600
30600000 Israel
(Israel)

ph. +972-4-6364015

Fax +972-4-6364004

www.dexcel.com/

Jordan

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Jordan

THE ARAB DRUG STORE

Khaleel Al Salem street
Amman
(Jordan)

ph. +962 6 5502995

Fax +962 6 5502984

Kenya

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Kenya

Nairobi X-Rays Supplies Ltd.

P.O. Box 41669
Nairobi
(Kenya)

ph. +254 20446265-6-7-8

Fax +254 20 4448515/17

Lebanon

Local distributor

Lebanon

Unione Pharmaceutic. d'Orient

Rue du Musée Imm. Stephan QtrBadaro
Beyrouth
(Lebanon)

ph. +961 1 396085-6

Fax +961 1 396047

Lettonia

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Lettonia

A.Medical

Varkalu Str. 13A, Riga
LV-1067, Latvia

ph. +371 67113760

www.amedical.eu

Lithuania

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Lithuania

A.Medical

Varkalu Str. 13A, Riga
LV-1067, Latvia

ph. +371 67113760

www.amedical.eu

Mauritius

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Mauritius

The Mauritius Pharmacy

4, Louis Pasteur Str Forest Side
(Mauritius)

ph. +230 6762435

Fax +230 675 1387

Russia

Local distributor

Russia

Joint Stock Company R-Pharm

111, bld. 1, Leninsky Avenue,
119421, Moscow, Russia
Ph. +7 (495) 956-79-37
Fax +7 (495) 956-79-38

www.rpharm.ru

info@rpharm.ru

Saudi Arabia

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Saudi Arabia

SARABEEL COMMERCIAL EST.

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

ph. +966 12657 2246

South Africa

Local distributor

South Africa

AXIM - Head Office Midrand

63 Old Pretoria Road
Halfway House Ext 2
Midrand
1685
South Africa

ph. +27 113140140

Fax +27 113140141

Uganda

Local distributor

Uganda

Kampala X-Rays Suppliers

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

ph. +256 41 534313

Fax +256 41 349919

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

Asia Pacific

Australia

Local distributor

Australia

REGIONAL HEALTH CARE GROUP

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

ph. +61 296624144

Fax +61 296626040

China

Hong Kong - China

Taiwan - China

Local distributor

Taiwan - China

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

India

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India

Imaging Products (India) Ltd

Mumbai
(India)

ph. +91 9819725471

Fax +91 2228320208

Indonesia

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Indonesia

PT DIPA PHARMALAB INTERSAINS

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

ph. +62 215348644

Fax +62 2153676066

Japan

New Zealand

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New Zealand

REGIONAL HEALTH LIMITED

19C Orbit Drive
Mairangi Bay
(New Zealand)

ph. +64 94140040

Fax +64 94140041

Pakistan

Local distributor

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

South Korea

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

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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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SDS

ISOVUE^{^®} (IOPAMIDOL INJECTION) for Cardiac Cath

accordion

Overview

For more than three decades, ISOVUE^® (Iopamidol Injection) has been a market-leading nonionic, low osmolar iodinated contrast agent, chosen by major institutions around the world for use in their cardiac catheterization and interventional radiology procedures.

ISOVUE (Iopamidol Injection) is available in a selection of four concentrations:

ISOVUE-200 (Iopamidol Injection 41%)
ISOVUE-250 (Iopamidol Injection 51%)
ISOVUE-300 (Iopamidol Injection 61%)
ISOVUE-370 (Iopamidol injection 76%)

ISOVUE (Iopamidol Injection) is also available in multiple fill sizes, and in single-dose or bulk packaging options.

ISOVUE^®-250 (Iopamidol Injection 51%) Pharmacy Bulk Package (PBP) offers multi-dosing efficiency in 200 mL and 500 mL volumes for angiography.

With its wide range of iodine concentrations, which includes the highest concentration approved for use in the U.S. (370 mgI/mL), and lower concentrations more suitable for use with modern digital subtraction angiography (DSA) equipment, ISOVUE contrast represents a versatile imaging solution for the angiography suite.

Multiple studies worldwide confirm the safety of ISOVUE contrast, including in patients at risk for contrast-induced nephropathy (CIN). The most notable of these is the CARE Study.

The CARE Study

The Cardiac Angiography in Renally Impaired Patients (CARE) Study shows that there isn’t just one contrast agent for at-risk patients. Imagine that. Click here to review the data and results of this landmark clinical trial.

Ordering Information

ISOVUE^® (Iopamidol Injection)

Product / NDC Number	Description
ISOVUE^®-200 (Iopamidol Injection 41%)
0270-1314-30	Ten 50 mL vials
0270-1314-15	Ten 200 mL bottles

ISOVUE^®-250 (Iopamidol Injection 51%)
0270-1317-05	Ten 50 mL vials
0270-1317-02	Ten 100 mL bottles
0270-1317-09	Ten 150 mL bottles

ISOVUE^®-300 (Iopamidol Injection 61%)
0270-1315-25	Ten 30 mL vials
0270-1315-30	Ten 50 mL bottles
0270-1315-47	Ten 75 mL bottles
0270-1315-35	Ten 100 mL bottles
0270-1315-50	Ten 150 mL bottles

ISOVUE^®-370 (Iopamidol Injection 76%)
0270-1316-01	Ten 50 mL bottles
0270-1316-52	Ten 75 mL bottles
0270-1316-35	Ten 100 mL bottles
0270-1316-04	Ten 125 mL bottles
0270-1316-37	Ten 150 mL bottles

ISOVUE^®-250 (iopamidol injection 51%) Pharmacy Bulk Package
0270-1317-41	Ten 200 mL bottles

Questions?

Call Bracco Customer Service at 1-877-BRACCO-9 (1-877-272-2269), Option 2.

Brochure

For a brief introduction to ISOVUE products for Cardiac Catheterization

Download the ISOVUE Cardiac Catheterization brochure (PDF)

Prescribing Information

For more information on prescribing the ISOVUE product line to help determine which product best suits your needs:

Download the ISOVUE full Prescribing Information (PDF)

Download the ISOVUE Pharmacy Bulk Package full Prescribing Information (PDF)

For more information about the safety of ISOVUE products

Download the ISOVUE Safety Data Sheet (PDF)

Reimbursement

Reimbursement coding information for ISOVUE products for use in Cardiac Catheterization and Angiographic procedures. Please see important disclaimer information below.

Injectable Contrast Agents

X-ray – Nonionic Products	HCPCS Codes	Short Description	Product SKU	NDC:	Unit Size:	HCPCS Dosage:	HCPCS Billing Units:
ISOVUE^®-200 (iopamidol injection 41%)	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1314-30	0270-1314-30	10 x 50 mL vials/case	1 mL	50
ISOVUE^®-200 (iopamidol injection 41%)	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1314-15	0270-1314-15	10 x 200 mL vials /case	1 mL	200
ISOVUE^®-250 (iopamidol injection 51%)	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1317-05	0270-1317-05	10 x 50 mL vials / case	1 mL	50
ISOVUE^®-250 (iopamidol injection 51%)	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1317-02	0270-1317-02	10 x 100 mL bottles / case	1 mL	100
ISOVUE^®-250 (iopamidol injection 51%)	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1317-09	0270-1317-09	10 x 150 mL bottles / case	1 mL	150
ISOVUE^®-300 (iopamidol injection 61%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-25	0270-1315-25	10 x 30 mL vials / case	1 mL	30
ISOVUE^®-300 (iopamidol injection 61%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-30	0270-1315-30	10 x 50 mL vials /case	1 mL	50
ISOVUE^®-300 (iopamidol injection 61%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-47	0270-1315-47	10 x 75 mL bottles /case	1 mL	75
ISOVUE^®-300 (iopamidol injection 61%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-35	0270-1315-35	10 x 100 mL bottles /case	1 mL	100
ISOVUE^®-300 (iopamidol injection 61%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-50	0270-1315-50	10 x 150 mL bottles / case	1 mL	150
ISOVUE^®-370 (iopamidol injection 76%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-30	0270-1316-30	10 x 50 mL vials / case	1 mL	50
ISOVUE^®-370 (iopamidol injection 76%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-52	0270-1316-52	10 x 75 mL bottles / case	1 mL	75
ISOVUE^®-370 (iopamidol injection 76%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-35	0270-1316-35	10 x 100 mL bottles /case	1 mL	100
ISOVUE^®-370 (iopamidol injection 76%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-04	0270-1316-04	10 x 125 mL bottles / case	1 mL	125
ISOVUE^®-370 (iopamidol injection 76%)	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-37	0270-1316-37	10 x 150 mL bottles / case	1 mL	150
ISOVUE^®-250 (iopamidol injection 51%) Pharmacy Bulk Package	Q9966	LOCM 200-299mg/mL iodine, 1 mL	1317-41	0270-1317-41	10 x 200 mL bottles / case	1 mL	200
ISOVUE^®-300 (iopamidol injection 61%) Pharmacy Bulk Package	Q9667	LOCM 300-399mg/mL iodine, 1 mL	1315-41	0270-1315-41	10 x 200 mL bottles / case	1 mL	200
ISOVUE^®-300 (iopamidol injection 61%) Pharmacy Bulk Package	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1315-98	0270-1315-98	6 x 500 mL bottles / case	1 mL	200
ISOVUE^®-370 (iopamidol injection 76%) Pharmacy Bulk Package	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-41	0270-1316-41	10 x 200 mL bottles / case	1 mL	200
ISOVUE^®-370 (iopamidol injection 76%) Pharmacy Bulk Package	Q9967	LOCM 300-399mg/mL iodine, 1 mL	1316-98	0270-1316-98	6 x 500 mL bottles / case	1 mL	200

The information provided above is general reimbursement information for ISOVUE products. It is not legal advice, nor is it advice about how to code, complete or submit any particular claim for payment. Although we supply this information based on our current knowledge, it is always the provider’s responsibility to determine and submit appropriate codes, charges, modifiers and bills for the services that were rendered. This coding and reimbursement information is subject to change without notice. Payers or their local branches may have their own coding and reimbursement requirements and policies. Before filing any claims, providers should verify current requirements and policies with the payer.

Our reimbursement experts can assist you in finding answers to coding and reimbursement questions.

Contact the Bracco Reimbursement Hotline at:

1-800-349-1388
askbracco@reimbursement.bracco.com
Monday through Friday 9:00 AM – 6:00 PM (EST)

Ask coding and billing questions regarding Bracco Diagnostics products and procedures related to those products.

Coding for products and procedures
Medicare payment

Bracco Diagnostics Inc. is pleased to provide customers with reimbursement support for products manufactured by the company and for medical procedures related to those products based on Medicare reimbursement policies. Because private payer coverage policies and benefit plans greatly differ, the information offered in this guide may not be applicable for billing and reporting to private payers. The treating provider is responsible for determining the medical necessity for each specific patient case. Claims submitted to payers should reflect the medical decisions made by the treating provider, current applicable state and federal regulations, and the provisions of the patient benefit plan. Bracco Diagnostics Inc. adheres to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provisions and other applicable state and federal laws concerning the disclosure of protected health information (PHI). Our Reimbursement Services department does not enter into Business Associate Agreements (BAA) with customers. Therefore your institution should not disclose PHI to Bracco reimbursement representatives during the course of receiving reimbursement support.

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Reimbursement >

Find your local rep

Find Your Local Bracco Rep. >

Contacts

Customer Service

1-877-272-2269

Drug Safety

1-800-257-5181, Option 1

Professional Services

1-800-257-5181, Option 2

Indications and Usage

ISOVUE^® (Iopamidol Injection)
Indications and Usage:
ISOVUE^®-200, 250, 300, 370
ISOVUE^® (Iopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging. Please consult full prescribing information for detailed product usage.

ISOVUE^®-250 (Iopamidol Injection 51%) Pharmacy Bulk Package*
ISOVUE^® (Iopamidol Injection) Pharmacy Bulk Package (PBP) is indicated for adult and pediatric intravenous excretory urography.

*The ISOVUE (Iopamidol Injection) Pharmacy Bulk Package is Not for Direct Infusion.

IMPORTANT SAFETY INFORMATION:
ISOVUE (Iopamidol Injection) IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as ISOVUE-M 200 (Iopamidol Injection 41%), and ISOVUE-M 300 (Iopamidol Injection 61%) for intrathecal administration.

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.

As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.

Please see full Prescribing Information for ISOVUE (Iopamidol Injection) by clicking here.

Please see full Prescribing Information for ISOVUE (Iopamidol Injection) Pharmacy Bulk Package 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.

ISOVUE and ISOVUE-M are currently manufactured for Bracco Diagnostics Inc. at three locations: BIPSO GmbH, Singen (Germany), Patheon Italia S.p.A., Ferentino (Italy) and S. M. Farmaceutici SRL, Tito (Italy).

ISOVUE and ISOVUE-M are registered trademarks of Bracco Diagnostics Inc.