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Sistemas Medicos, LTDA.

Apartado Aereo 24456
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Lifenir S.A.

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

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ph. +582-12-793-3222
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EWOPHARMA AG

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ph. +359 29624478
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LERIVA IMAGING S.A.

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ph. +30 210-6199886
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EWOPHARMA REPRESENTATION OFFICE

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Caroga Pharma PVT. Ltd

P.O.Box 12627
Addis Abeba
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ph. +251 11 4654944 / 11 4161090
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Cyndex Pharmacy

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P.O. Box 41669
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Unione Pharmaceutic. d'Orient

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MANARA HEALTHCARE

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REGIONAL HEALTH CARE GROUP

3-11 Primrose Avenue Rosebery
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Imaging Products (India ) Ltd

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ph. +91 9819725471
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Jl. Panjang No. 10
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Jakarta 11530
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ph.  +62 215348644
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S. EJAZUDDIN & CO LTD

PO Box 5629 - Zia Plaza
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ph. +92 21212032
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NEW MARKETLINK INTERNATIONAL CORP

Tao Corporate Centre 2291
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Ext Makati City Metro
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ph. (632) 836-5838
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LF ASIA PHARMACEUTICAL DIVISION

Healthcare Distribution Centre
24 Penjuru Road (off Penjuru Close)
#03-04 CWT Commodity Hub
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ph. +65 65097629
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SUPER FORTUNE ENTERPRISE CO LTD

5 F-1 - 42 Sec.1 Ming
Sheng E. Road Jehovah Building
101 Taipei
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ph. +886 225673456
Fax +886 225319231
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Interpharmacare Co., Ltd.

90 Moo 13 Soi Mahacha
Bangpleeyai
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Samutprakarn 10540
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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
 

Select your country

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REGIONAL HEALTH CARE GROUP

3-11 Primrose Avenue Rosebery
NSW 2018 - Sydney
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ph. +61 296624144
Fax +61 296626040
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India

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
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ph. +64 94140040
Fax +64 94140041
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S. EJAZUDDIN & CO LTD

PO Box 5629 - Zia Plaza
Altaf Hussain Road
74000 Karachi
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ph. +92 21212032
Fax +92 212629716
Philippines

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Philippines

NEW MARKETLINK INTERNATIONAL CORP

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

ph. (632) 836-5838
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Singapore

LF ASIA PHARMACEUTICAL DIVISION

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

ph. +65 65097629
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

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HOANG GIA INVESCO, JSC

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

ph. +43 7846952

North & South America

Argentina

Local distributor

Argentina

JUSTESA IMAGEN ARGENTINA, S.A.

Viamonte 1328, 9º piso
1053 Buenos Aires
(Capital Federal)

ph. +5411 4373-0629
Colombia

Local distributor

Colombia

Sistemas Medicos, LTDA.

Apartado Aereo 24456
Calle 58 No. 35A61
Bogota
(Colombia)

ph. +571-221-9837
Fax +571-222-5310
Perù

Local distributor

Perù

REIMED, SCRL

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

ph. 511-448-1087
Fax 511-448-3447
Uruguay

Local distributor

Uruguay

Lifenir S.A.

Justicia 2069
C 11800 Montevideo
(Uruguay)

ph. +5982-400-3020
Fax +5982-4007320
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Venezuela

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

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Bosnia-Herzegowina

Bulgaria

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Bulgaria

EWOPHARMA AG

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

ph. +359 29624478
Fax +359 28683968
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Croatia

Greece

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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
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EWOPHARMA A.G. ROMANIA

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

ph. +40 212601344
Fax +40 212029327
Serbia

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Serbia

Slovenia

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Slovenia

Ungheria

Local distributor

Ungheria

EWOPHARMA REPRESENTATION OFFICE

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

ph. +36 12004650
Fax +36 13980316

Eastern Europe, Middle East & Africa

Ethiopia

Local distributor

Ethiopia

Caroga Pharma PVT. Ltd

P.O.Box 12627
Addis Abeba
(Ethiopia)

ph. +251 11 4654944 / 11 4161090
Fax +251 11 4654595
Ghana

Local distributor

Ghana

Cyndex Pharmacy

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

ph. +233 21553370
Fax +233-244366622 / 21850072
Israel

Local distributor

Israel

DEXCEL

Or-Akiva 30600
30600000 Israel
(Israel)

ph. +972-4-6364015
Fax +972-4-6364004
Jordan

Local distributor

Jordan

THE ARAB DRUG STORE

Khaleel Al Salem street
Amman
(Jordan)

ph. +962 6 5502995
Fax +962 6 5502984
Kenya

Local distributor

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
Mauritius

Local distributor

Mauritius

The Mauritius Pharmacy

4, Louis Pasteur Str Forest Side
(Mauritius)

ph. +230 6762435
Fax +230 675 1387
Saudi Arabia

Local distributor

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

121 Gazelle Avenue
Corporate Park South
Midrand Johannesburg 2000
(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
Ukraine

Local distributor

Ukraine

DELTA MEDlCAL

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

ph. +38 445933355

RESP product logo

ProHance® (Gadoteridol) injection, 279.3 mg/mL is the first macrocyclic gadolinium MRI contrast agent approved in the United States for CNS MRI.1

1. ProHance® (Gadoteridol) injection full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; Nov 2013.

Thumbnails

RESP product logo

SDS

For more information about the safety of the ProHance products Download the Safety Data Sheet (PDF)

ProHance® (Gadoteridol) injection, 279.3 mg/mL

accordion

ProHance® (Gadoteridol) injection, 279.3 mg/mL is one of the most stable macrocyclic gadolinium-based contrast agents (GBCAs), with a molecular structure that "cages" gadolinium inside.1,2 Out of 9 GBCAs in the marketplace, ProHance is the only agent approved for a cumulative dose of 0.3 mmol/kg.1

ProHance (Gadoteridol) injection, 279.3 mg/mL provides macrocyclic GBCA stability, along with proven efficacy. The TRUTH study showed no significant difference in detection and characterization of central nervous system (CNS) lesions with ProHance® (Gadoteridol) when compared to Gadavist®. In addition, no difference was found by any reader for any of the 5 qualitative image evaluation endpoints:3

  • Global diagnostic preference
  • Lesion border delineation
  • Definition of disease extent
  • Visualization of lesion internal morphology
  • Lesion contrast enhancement

ProHance provided improved delineation and enhancement of primary and secondary neoplastic lesions of the brain and spine in children.4 In a multicenter clinical trial of 103 children, 60% of scans were enhanced, and 30-95% of scans resulted in additional diagnostic information.1

All trademarks and registered trademarks are the property of their respective owners.

1. ProHance (Gadoteridol) injection full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; Nov 2014. 2. Idée JM, Port M, Robic C, Medina C, Sabatou M, Corot C. Role of thermodynamic and kinetic parameters in gadolinium chelate stability. J Magn Reson Imaging. 2009;30(6):1249–1258. 3. Maravilla KR, Smith MP, Vymazal J, et al. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015;36(1):14–23. 4. Byrd SE, Darling CF, Wilczynski MA. Magnetic resonance imaging of the central nervous system in children with a new nonionic gadolinium contrast agent—gadoteridol injection (ProHance). J Natl Med Assoc. 1993; 85(5):361-366.

ProHance products are available in 5, 10, 15, and 20 mL single dose vials, 50 mL Multipack (Pharmacy Bulk Packages*), and prefilled syringes.

SINGLE-DOSE VIALS NDC Number
5 mL Vials 0270-1111-04
10 mL Vials 0270-1111-01
15 mL Vials 0270-1111-02
20 mL Vials 0270-1111-03

 

PHARMACY BULK PACKAGES NDC Number
50 mL Multipack 0270-1111-70
*Not for Direct Infusion

 

PRE-FILLED SYRINGS NDC Number
10 mL Prefilled Syringe 0270-1111-16
17 mL Prefilled Syringe 0270-1111-45

 

Questions?

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

For more information on prescribing ProHance single dose vials and prefilled syringes

For more information on prescribing the ProHance® MultipackTM products

For more information about the safety of the ProHance product line

Reimbursement coding information for the ProHance product line. Please see important disclaimer information below.

Injectable Contrast Agents

MRI Products 2017 HCPCS Codes Short Description Product SKU NDC: Unit Size: HCPCS Dosage: HCPCS Billing Units:
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-04 0270-1111-04 5x5 mL vials/box 1 mL 5
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-01 0270-1111-01 5x10 mL vials/box 1 mL 10
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-02 0270-1111-02 5x15 mL vials/box 1 mL 15
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-03 0270-1111-03 5x20 mL vials/box 1 mL 20
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-16 0270-1111-16 5x10 mL prefilled hand held syringes/box 1 mL 10
ProHance® (Gadoteridol) Injection, 279.3 mg/mL A9579 Gad-base MR Contrast NOS, 1 mL 1111-45 0270-1111-45 5x17 mL prefilled hand held syringes/box 1 mL 17
ProHance® MultipackTM (Gadoteridol) Injection, 279.3 mg/mL A9576 Inj. ProHance Multipack 1111-70 0270-1111-70 5x50 mL bottles/box 1 mL 50

The information provided above is general reimbursement information for ProHance products. It is not legal 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:

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.

Millions of doses, safety profile comparable to other CNS MRI contrast agents.2

Bracco Diagnostics Inc. maintains an ongoing commitment to patient safety. ProHance (Gadoteridol) injection, 279.3 mg/mL is safe for use in children (> 2 years) or those with renal insufficiency.2 It is the only agent still FDA approved for a cumulative dose of 0.3 mmol/kg. The ACR categorizes ProHance (Gadoteridol) injection, 279.3 mg/mL as a group 2 agent.3 In fact, there are no unconfounded cases of nephrogenic systemic fibrosis (NSF) with ProHance (Gadoteridol) injection, 279.3 mg/mL in published, peer reviewed literature.4

With more than 22 million doses administered worldwide, ProHance (Gadoteridol) injection, 279.3 mg/mL has a comparable safety profile to other CNS MRI gadolinium-based contrast agents.1 In clinical trials, the majority of observed adverse events or reactions were transient, self-limiting, and mild in intensity. The most frequently reported adverse events were taste perversion (1.4%) and nausea (1.4%).2

Click here for the FDA NSF Safety Update

1. MultiHance global dosing from 2004 to 2015 and ProHance global dosing from 1992 to 2015. (Data on file at Bracco Diagnostics Inc.) September 2015. 2. ProHance (Gadoteridol) injection full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; July 2014. 3. ACR Manual on Contrast Media, Version 10.2, 2016. 4. Shellock FG, Crues JV III, editors. MRI: Bioeffects, Safety, and Patient Management. © 2014 by Biomedical Research Publishing Group, Los Angeles, CA.

Detection and characterization of CNS lesions with ProHance (Gadoteridol) injection, 279.3 mg/mL was not significantly different when compared to Gadavist®.

  • Gadavist does not demonstrate the clinical benefits for diagnostic performance associated with high relaxivity
  • Minimal differences in relaxivity between ProHance (Gadoteridol) injection, 279.3 mg/mL and Gadavist do not demonstrate clinical differences in routine neuroradiological applications of CNS MRI

Figure 1: No significant difference in lesion enhancement or morphology

In the TRUTH study,1 a multicenter, double-blind, randomized, intraindividual cross-over study of 209 patients, ProHance (Gadoteridol) injection, 279.3 mg/mL showed comparative enhancement compared with Gadavist. In the image above, a 61-year-old man with brain metastases fom primary lung cancer underwent MR imaging. T1 GRE images show no differences in contrast enhancement or in the size of lesions.

All trademarks and registered trademarks are the property of their respective owners.

1. Maravilla KR, Smith MP, Vymazal J, et al. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015;36(1):14–23.

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Find your local rep

Contacts

Customer Service 1-877-BRACCO-9
(1-877-272-2269), Option 2

Drug Safety

1-800-257-5181, Option 1

Professional Services

1-800-257-5181, Option 2

Indications and Usage

Indications and Usage:
Central Nervous System
ProHance® (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues
ProHance (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY INFORMATION:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
    • acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration (see WARNINGS).

As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.

Please see full Prescribing Information for ProHance (Gadoteridol) Injection, 279.3 mg/mL including boxed WARNING by clicking here .

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

ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).

ProHance is a registered trademark of Bracco Diagnostics Inc.

ProHance Multipack is a trademark of Bracco Diagnostics Inc.

All trademarks and registered trademarks are the property of their respective owners.