MultiHance^® (gadobenate dimeglumine) injection, 529 mg/mL

INDICATIONS:

The EmpowerMR^® Injector System is indicated for vascular administration of contrast media and flushing media in conjunction with magnetic resonance imaging (MRI).

Protocols have been independently developed and are not intended as medical advice and Bracco shall not be responsible for any physicians' reliance on these or any other protocols.

Bracco Injeneering S.A. reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation.

Not all products available in all global markets.

EmpowerMR is distributed by Bracco Diagnostics Inc.; 259 Prospect Plains Road, Bldg. H Monroe Township, NJ 08831 USA; Phone: (800) 631-5245, Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269).
Professional Services: 1-800-257-5181 (Option 2)
EmpowerMR Email: BRACCO@diag.bracco.com
Websites: imaging.bracco.com/us-en

EmpowerMR is manufactured by Bracco Injeneering S.A., Avenue de Sevelin 46 CH – 1004 Lausanne, Switzerland. https://imaging.bracco.com

About Bracco Injeneering S.A.
Bracco Injeneering S.A., located in Lausanne, Switzerland, is the most recently added Business Unit of Bracco Imaging. Bracco Injeneering is committed to develop the best-in-class integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging’s expertise.

Thanks to this strengthened product portfolio, including the CT Exprès^® 3D Contrast Media Delivery System, EmpowerCTA^®+ Injector System, EmpowerMR^® Injector System, NEXO Contrast Management System and NEXO [DOSE]^® Multi-Modality Radiation Informatics, Bracco Imaging will be able to focus on constant innovation, not only for devices, but also for software development and data management.

CT Exprès, EmpowerCTA, EmpowerMR, IRiSMR, NEXO and NEXO [DOSE] are registered trademarks of Bracco Injeneering S.A., registered in the U.S.

Microsoft and Windows are registered trademarks of Microsoft Corporation.

Indications and Usage:
CENTRAL NERVOUS SYSTEM
ProHance^® (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

EXTRACRANIAL/EXTRASPINAL HEAD AND NECK
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

CONTRAINDICATIONS
Contraindicated in patients with known allergic or hypersensitivity reactions to ProHance.

WARNINGS AND PRECAUTIONS
Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.
Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment. Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Consider these risks, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function.
Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.

ADVERSE REACTIONS
The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9%.

USE IN SPECIFIC POPULATIONS
Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.
Lactation: There are no data on the presence in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
Pediatric Use: The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.

Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding ProHance (Gadoteridol) Injection, 279.3 mg/mL including boxed WARNING by clicking here.

Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding ProHance Multipack^TM products 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.

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.