Bracco’s MRI Innovations | The Max 3™ Syringeless Injector System Delivers Peak Performance in the MR Suite

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., is optimizing efficiency and workflow in the MR suite with the Max 3™ Rapid Exchange and Syringeless Injector System. The Max 3 is the first of its kind in the MRI space, empowering intuitive, efficient workflow to maximize staff time and elevate patient care.

“MRI is all about innovation, and the Max 3 brings a new way of delivering contrast during the scan,” said Pete Nardell, Associate Director of Device and Informatics Marketing at Bracco. “Traditionally, MRI requires hand injections for most MRI contrasted protocols. The Max 3 delivers contrast in a more efficient way, with a precise dose through an automated contrast delivery system.”

Delivering Workflow Efficiency

The syringeless Max 3 offers direct MR contrast injection, which is different from administering contrast via a handheld syringe filled with contrast media from a vial. This eliminates the need to fill syringes. It also allows for quick and easy operation to accommodate fast and simple patient changeover.

“For the first time, we have a patient-centric injector that's completely wireless and syringeless. From a technologist standpoint, the Max 3 expedites workflow,” said Omar Romero, Imaging Clinical Application Specialist at Bracco.

The intuitive user interface offers detailed directions through every phase of the contrast injection to streamline the contrast administration. “It gives staff step-by-step directions, so there is no questioning of what to do next. This helps increase workflow efficiency within the MRI suite, while allowing more table time and giving that time back to the patient,” said Amy Black, Bracco’s Marketing Manager for Devices and Informatics.

The Max 3 delivers peak performance and increases workflow efficiencies, allowing technologists to quickly and effectively manage contrast injections. “The Max 3 revolutionizes MR contrast,” said Lane Kidd, MSRS, RT(R), Senior Imaging Application Specialist at Bracco. “The system does a lot of thinking for you. The injector control unit displays what to do next, and the color coding helps you know when you can move on. It’s intuitive, easy to use and easy to store.”

Ergonomically Designed

The Max 3 has an all-in-one space saving design that is portable and easy to navigate. At only 40 kg, it’s ergonomically designed with a front roller handle that makes it easy to move around the MR suite. It’s wireless with no power cables while in use, so it can be positioned anywhere in the MRI room up to a maximum magnetic field strength of 50mT.

The injector also has a dedicated Wi-Fi connection for direct wireless communication and streamlined operations. Plus, it charges quickly and can run 18 hours of continuous use on a full charge. When the battery runs low, a message will display, indicating the remaining battery percentage before it should be recharged, which is done outside of the MRI suite.

Focusing on Patient Safety

The Max 3 includes advanced safety features to maximize patient safety. These include a built-in automatic air detection technology, pressure sensors and a proprietary particle filtration system. “The safety features on the Max 3 are very exciting for both technologists and patients. One of the great features is the multiple points of air detection and particle detection, along with it being a hygienic closed system,” said Black.

The Easy-Click-Cassette flex has a dedicated connector to the patient tubing with SafeConnect consumables that enable aseptic techniques. This provides contact protection and reliable protection against retrograde contamination. This set is designed to be used within 24 hours or up to a maximum of 96 injections, whichever comes first. This helps improve workflow for the technologist and gives them more time to focus on the patient during a procedure.

During contrast delivery, it’s critical to avoid introducing air into the vein. The Max 3 is designed to detect this issue and ensure patient safety throughout the injection. An adjustable KVO keeps the vein open for safe contrast delivery. “We can adjust the time to keep that vein open, which is important because all MRI scans vary on timing, and we don't want the concern for an occlusion during the scan,” said Black.

Supporting Sustainability in Imaging

The Max 3 represents Bracco’s commitment to caring for the patient, the medical ecosystem and the future of the planet. Nardell said this injector will strengthen green efforts in MRI suites because it contributes less plastic to a hospital's disposable processes and lowers the associated costs of managing this waste. It also helps optimize contrast utilization to reduce gadolinium contrast waste.

“One of Bracco's main initiatives is sustainability, not only from the way we develop products, but also the way we maintain them. With the Max 3 syringeless injector, we're reducing the amount of plastics by taking away the syringe,” said Nardell.

Optimizing Images with Precision Dosing

The Max 3 ensures precise and repeatable contrast delivery, contributing to uniform image quality across exams. “Precision dosing not only eliminates contrast waste, it maximizes image optimization. The Max 3 allows providers to administer a precise contrast dose to each patient based on their specific exam, delivering an optimal image at an optimal contrast volume,” said Nardell.

It’s designed to work seamlessly with Bracco’s VUEWAY® (gadopiclenol) solution for injection. VUEWAY provides effective contrast enhancement at half the gadolinium (Gd) dose (0.05 mmol/kg) vs. a macrocyclic GBCA at a dose of 0.1 mmol/kg of other similar contrast media for approved indications in the U.S.¹ Together, VUEWAY and the Max 3 injector system enable precision dosing for a variety of patients.

“With the Max 3, we can do fractional dosing, which is great. You can dial in small volume injections for pediatric patients or anybody who requires minimizing that injection as much as possible. Anytime you can minimize the effective dose, you're benefiting everybody,” said Romero.

Driving Innovation in MRI

The Max 3 represents Bracco’s commitment to innovation and purpose-driven progress, underscoring the company's ongoing dedication to advancing diagnostic imaging while keeping both patients and healthcare providers at the center of its mission. As a significant addition to Bracco’s growing MRI portfolio, the Max 3 showcases the company’s investment in cutting-edge technology that enhances clinical performance.

The system was developed through a partnership between Bracco Imaging and ulrich GmbH Co. KG, a German medical device manufacturer specializing in the design of contrast media injectors and spinal implants. This strategic collaboration brings Max 3 to the United States under an exclusive private label arrangement.

“The Max 3 shows our commitment to our customers and innovation itself. Bracco is dedicated to bringing innovation and the best products to MR, and the Max 3 brings something new that the U.S. market has not seen yet,” said Black.

With Max 3 and VUEWAY, Bracco is not only expanding its product line — it’s reinforcing its leadership in MRI contrast agent innovation and advancing its role as a trusted partner in radiology. “Bracco is very purpose-driven in terms of what we provide for patients and providers,” said Romero. “The Max 3 and VUEWAY minimize dose for patients and allows us to be a patient-focused and purpose-driven partner to our customers.”

References

1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL. Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.

ulricheasyINJECT Max 3™ (the Bracco-branded Max 3™, a Rapid Exchange and Syringeless MR Injector System) is distributed by Bracco Diagnostics Inc.

Indications for use

ulricheasyINJECT Max 3 is a contrast media (CM) management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY® (gadopiclenol) solution for injection – Bracco Diagnostics Inc., MultiHance® (gadobenate dimeglumine) injection – Bracco Diagnostics Inc., Clariscan™ (gadoterate meglumine) injection – GE Healthcare Inc., DOTAREM® (gadoterate meglumine) Injection – Guerbet, LLC, Gadavist® (gadobutrol) injection – Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection – Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist (gadobutrol) Injection – Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection – Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

The ulricheasyINJECT Max 3 is not intended for injection of contrast media for high-pressure angiography.

Easy-Click-Cassette – flex Max 3 is used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.

Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Use time expiration per IBP contrast media container is a maximum of twenty-four (24) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

Contraindications

ulricheasyINJECT Max 3 injectors are not intended for the administration of contrast medium during high-pressure angiography or other applications that do not comply with the intended use.

The injector is not protected against the effects of defibrillation. Before a defibrillator is used, the patient must be disconnected from the ulricheasyINJECT Max 3 injector.

Do not add any disposables (i.e. connector tubing or valves) to the ulricheasyINJECT Max 3 with the patient tubing that are not provided by ulrich medical. No valves or other connectors may be placed

in-line between the patient tubing and the patient cannula. The disposables identified in this IFU are designed, manufactured, and tested for connection with cannulas for pressure injections.

Do not use ulricheasyINJECT Max 3 injectors with any other contrast media (other than those described in the IFU). Any other contrast media are inappropriate and should not be used. Do not operate the injector and terminal, including any accessories, in potentially explosive atmospheres or in the vicinity of combustible materials (especially anesthetic drugs, detergents, and oxygen-enriched environments).

ulricheasyINJECT Max 3 is manufactured by ulrich GmbH & Co. KG.

ulrich medical is a registered trademark of ulrich GmbH & Co. KG.

ulricheasyINJECT Max 3 is a trademark of ulrich GmbH & Co. KG.

ulricheasyINJECT Max 3 is distributed as the Bracco-branded Max 3, a Rapid Exchange and Syringeless MR Injector System, by Bracco Diagnostics Inc.; 510 Carnegie Center, Suite 300, Princeton, NJ 08540 USA; Phone: (800) 631- 5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Scientific Information: 1-800-257-5181 (Option 2); Website:https://smartinject.com/max3/

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

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

VUEWAY® (gadopiclenol) solution for injection

Indications

VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

• the central nervous system (brain, spine, and associated tissues),
• the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. VUEWAY is not approved for intrathecal use.

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 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/1.73 m²), 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, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
• For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindications

VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY.

Warnings and Precautions

There are risks associated with intrathecal use of GBCAs that can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of VUEWAY have not been established with intrathecal use and VUEWAY is not approved for intrathecal use.

Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.

Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration.

Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.

Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent.

Extravasation and injection site reactions can occur with administration of VUEWAY. Ensure catheter and venous patency before the injection of VUEWAY.

VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan.

The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%).

POST-MARKETING EVENTS

The following adverse reactions have been identified during postmarketing use of GBCAs. Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration.

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.

Please click herefor full Prescribing Information for VUEWAY (gadopiclenol) solution for injection including BOXED WARNING on Nephrogenic Systemic Fibrosis.

Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616. VUEWAY is a registered trademark of Bracco Imaging S.p.A.

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

ProHance® (Gadoteridol) Injection, 279.3 mg/mL
and
ProHance® Multipack™ (Gadoteridol) Injection, 279.3 mg/mL

Indications and Usage:

CENTRAL NERVOUS SYSTEM

ProHance 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 TISSUES

ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. ProHance is not approved for intrathecal use.

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.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ProHance have not been established with intrathecal use and ProHance is not approved for intrathecal use.

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%.

POST-MARKETING EVENTS

The following adverse reactions have been identified during post approval use of Prohance or other GBCAs: Acute pancreatitis within 48 hours of GBCA administration has been reported.

Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.

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.

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.

Please click here for full Prescribing Information and Patient Medication Guide for additional safety information for ProHance (Gadoteridol) Injection, 279.3 mg/mL.

Please click herefor full Prescribing Information and Patient Medication Guide for additional safety information for ProHance Multipack.

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.

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

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

and

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

Indications and Usage:

MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL is a gadolinium-based contrast agent indicated for intravenous use in:

• Magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates) to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues
• Magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio- femoral occlusive vascular disease

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. MultiHance is not approved for intrathecal use.

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 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/1.73 m²), 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, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
• For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

CONTRAINDICATIONS

MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents.

WARNINGS AND PRECAUTIONS

Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of MultiHance have not been established with intrathecal use and MultiHance is not approved for intrathecal use.

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 MultiHance administration and resolved with prompt emergency treatment. Consider the risk for hypersensitivity reactions, 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. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the 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. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.

Acute Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred with the use of GBCAs. The risk of renal failure may increase with increasing dose of the contrast agent. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.

Extravasation and Injection Site Reactions: Extravasation of MultiHance may lead to injection site reactions, characterized by local pain or burning sensation, swelling, blistering, and necrosis. Exercise caution to avoid local extravasation during intravenous administration of MultiHance.

Cardiac Arrhythmias: Cardiac arrhythmias have been observed in patients receiving MultiHance in clinical trials. Assess patients for underlying conditions or medications that predispose to arrhythmias. The effects on QTc by MultiHance dose, other drugs, and medical conditions were not systematically studied.

Interference with Visualization of Certain Lesions: Certain lesions seen on non-contrast images may not be seen on contrast images. Exercise caution when interpreting contrast MR images in the absence of companion non-contrast MR images.

ADVERSE REACTIONS

The most commonly reported adverse reactions are nausea (1.3%) and headache (1.2%).

POST-MARKETING EVENTS

The following adverse reactions have been identified during post approval use of MultiHance or other GBCAs: Acute pancreatitis within 48 hours of GBCA administration has been reported.
Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.

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 is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, limited literature reports that breastfeeding after MultiHance administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose.

Pediatric Use: MultiHance is approved for intravenous use for MRI of the CNS 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 less than 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No dose adjustment according to age is necessary in pediatric patients two years of age and older. For pediatric patients, less than 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg. The safety of MultiHance has not been established in preterm neonates.

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

Please click here for Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance (gadobenate dimeglumine) injection, 529 mg/mL.

Please click here for Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance Multipack.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia S.p.A., Ferentino, Italy.

MultiHance is a registered trademark of Bracco International B.V. MultiHance Multipack is a trademark of Bracco International B.V.

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

US-MAX3-2500020 07/25