Ultravist® (iopromide) injection 300|370 mg Iodine/mL

Experience and Versatility for Today’s Radiology Practice

An integral part of our Computed Tomography (CT) portfolio, Ultravist is an FDA-approved contrast agent with over 30 years of experience in the US (See full and complete indications below).

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A Commitment to Contrast Supply Availability

Ultravist supply is supported by ongoing manufacturing investment and infrastructure to help ensure consistent product availability.

24/7 manufacturing of Bayer contrast agents at German production facilities
Established alternative manufacturing networks to support availability

Learn more about Bayer’s commitment to Ultravist supply in our Customer Supply Letter.

Ordering Information

Ultravist is available through a broad network of suppliers that also distribute our other imaging products for a full listing please click here.
How to Order from our 3PL partner directly:
Contact Bayer’s Pharmaceuticals primary distributor:
McKesson Specialty Distribution
1-877-259-4624 (Option #1)
mshbayercustomerservice@mckesson.com
Or contract your local distributor.
Benefits of Purchasing Through McKesson Specialty

Avoid additional shipping charges
Receive a 2% prompt-pay discount when invoices are paid within 30 days

Reimbursement information can be found here, or by contacting the reimbursement helpline at 1-800-423-7539.

Additional Ordering Information

Indications

Intravenous Procedures*:

Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older
Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound
Excretory urography in adults and pediatric patients aged 2 years and older.

Intra‐arterial Procedures*:

Cerebral arteriography and peripheral arteriography in adults
Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults
Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older.

*Specific concentrations and presentations of Ultravist are recommended for each type of imaging procedure (see Dosage and Administration 2.2, 2.3, 2.4 in the Full Prescribing Information).

Portfolio Flexibility and Versatility

Ultravist is offered in two concentrations and multiple presentations, single-dose vials and Imaging Bulk Packages, allowing facilities to choose the presentation that best fits their operational needs.

Ultravist 370 offers one of the most concentrated forms of iodine per mL, allowing the administration of lower contrast volume while maintaining iodine load.

Explore the full range of Ultravist presentations and concentrations in the provided chart.

Ultravist Concentrations and Presentations

Concentration Options	Single-Dose Vial Presentation Options	Imaging Bulk Package (IBP) Presentation Options
300 mg Iodine/mL	50 mL 100 mL 150 mL	200 mL 500 mL
370 mg Iodine/mL	50 mL 100 mL 150 mL	200 mL 500 mL

The Power of Imaging Bulk Package (IBP)*

Streamlined Workflow

One multi-dose set up in the CT scan room eliminates the need to reach for several single-dose vials throughout the day

Reduced Waste

Compared to single-dose vials, the Imaging Bulk Package may enable more complete contrast usage

Customized Patient Dosing

Technologist and nurse staff can prepare and administer weight-based doses for patients directly in the scan room

Ultravist Imaging Bulk Package is intended to be used in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
*Ultravist IBP is indicated for CT and CEM only.

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Ultravist is Part of the Bayer CT Portfolio of Solutions

A complete CT portfolio designed to support patient-centered care with integrated contrast, injection and software solutions.

MEDRAD® Stellant FLEX Injection System

MEDRAD® Centargo Injection System

Quality Syringes and Disposables

Software and Services for Workflow Efficiency and Performance

Bayer Radiology contrast and device products should be used in accordance with the prescribing information and instructions for use, respectively.

Safety Profile in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.

The common adverse reactions reported in >1% of patients in clinical studies with Ultravist are shown in the table below.

Adverse reactions reported in >1% of patients receiving Ultravist in clinical trials

System Organ Class	Adverse Reaction	Ultravist N=1,142 (%)
Nervous system disorders	Headache Dysgeusia	46 (4) 15 (1.3)
Eye disorders	Abnormal vision	12 (1.1)
Cardiac disorders	Chest pain	18 (1.6)
Vascular disorders	Vasodilation	30 (2.6)
Gastrointestinal disorders	Nausea Vomiting	42 (3.7) 22 (1.9)
Musculoskeletal and connective tissue disorders	Back pain	22 (1.9)
Renal and urinary disorders	Urinary urgency	21 (1.8)
General disorders and administration site conditions	Injection site and infusion site reactions (hemorrhage, hematoma, pain, edema, erythema, rash) Pain	41 (3.7) 13 (1.4)

Recommended Dosage for Intravenous Procedures in Adults

The recommended doses for Intravenous procedures in adults are shown in the tables below.

Recommended concentration and volume of Ultravist for intravenous procedures in adults

Imaging Procedure	Contrast Computed Tomography
Concentration (mg Iodine per mL)	300 (use single-dose vials)	370 (use single-dose vials)
CT of Head	50 mL to 200 mL	41 mL to 162 mL
CT of Body - Single Phase Contrast Bolus Injection Rapid Infusion	50 mL to 200 mL 100 mL to 200 mL	41 mL to 162 mL 81 mL to 162 mL
CT of Body - Multiple Phase Contrast	50 mL to 200 mL total volume Phase 1: 100% contrast Phase 2: 20% to 60% contrast, using a power injector suitable for simultaneous injection of contrast and 0.9% Sodium Chloride Injection	41 mL to 162 mL total volume Phase 1: 100% contrast Phase 2: 20% to 60% contrast, using a power injector suitable for simultaneous injection of contrast and 0.9% Sodium Chloride Injection
Maximum Total Dose	200 mL	162 mL

Imaging Procedure	Contrast Mammography
Concentration (mg Iodine per mL)	300 or 370 (use single-dose vials or imaging bulk package)
Contrast Mammography	1.5 mL/kg body weight using a power injector at 2 mL/second to 4 mL/second
Maximum Total Dose	150 mL

Imaging Procedure	Excretory Urography
Concentration (mg Iodine per mL)	300 (use single-dose vials)
Excretory Urography	1 mL/kg body weight
Maximum Total Dose	100 mL

Recommended Dosage for Intra-Arterial Procedures in Adults

The recommended doses for intra-arterial procedures in adults are shown in the tables below.
Inject at rates approximately equal to the flow rate in the vessel being injected.

Recommended concentrations and volume of Ultravist to administer per single injection for selected injection site of intra-arterial procedure in adults

Imaging Procedure	Cerebral Arteriography
Concentration (mg Iodine per mL)	300 (use single-dose vials)
Intra-Arterial Injection Sites
Carotid Arteries	3 mL to 12 mL
Vertebral Arteries	4 mL to 12 mL
Aortic Arch Injection (four vessel study)	20 mL to 50 mL
Maximum Total Dose	150 mL

Imaging Procedure	Peripheral Arteriography
Concentration (mg Iodine per mL)	300 (use single-dose vials)
Intra-Arterial Injection Sites
Subclavian or Femoral Artery	5 mL to 40 mL
Aortic Bifurcation (distal runoff)	25 mL to 50 mL
Maximum Total Dose	250 mL

Imaging Procedure	Coronary Arteriography and Left Ventriculography
Concentration (mg Iodine per mL)	370 (use single-dose vials)
Intra-Arterial Injection Sites
Right Coronary Artery	3 mL to 14 mL
Left Coronary Artery	3 mL to 14 mL
Left Ventricle	30 mL to 60 mL
Maximum Total Dose	225 mL

Imaging Procedure	Visceral Angiography and Aortography
Concentration (mg Iodine per mL)	370 (use single-dose vials)
Intra-Arterial Injection Sites
Aorta and Major Abdominal Branches	Individualize a volume approximately equal to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied
Maximum Total Dose	225 mL

Recommended Dosage in Pediatric Patients Aged 2 Years and Older

The recommended doses in pediatric patients aged 2 years and older are shown in the table below.
Safety and effectiveness of Ultravist have not been established in pediatric patients younger than 2 years for radiographic evaluation of cardiac chambers and related arteries, excretory urography, and contrast computed tomography of head and body.
Safety and effectiveness of Ultravist for cerebral arteriography, peripheral arteriography, coronary arteriography and left ventriculography, visceral angiography, aortography, and contrast mammography have not been established in pediatric patients.

Recommended concentrations and volume per body weight of Ultravist for cardiac chambers and related arteries, excretory urography, and contrast computed tomography in pediatric patients aged 2 and older

Imaging Procedure	Intra-Arterial	Intravenous
	Cardiac Chambers and Related Arteries	Excretory Urography	Contrast Computed Tomography
Concentration (mg Iodine per mL)	370 (use single-dose vials)	300 (use single-dose vials)	300 (use single-dose vials or imaging bulk package)
Volume (mL/kg per body weight)	1 to 2	1 to 2	1 to 2
Maximum Total Dose (mL/kg)	4	3	3

Dosage Forms and Strengths

Ultravist is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in two concentrations:

300 mg Iodine per mL provides 623.4 mg/mL iopromide
370 mg Iodine per mL provides 768.86 mg/mL iopromide

Important Dosage and Administration Information

Ultravist is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1)].
Specific concentrations and presentations of Ultravist are recommended for each type of imaging procedure [see Dosage and Administration in Full Prescribing Information (sections 2.2, 2.3, 2.4)].
Hydrate patients, as appropriate, prior to and following the administration of Ultravist [see Warnings and Precautions (5.3)].
Individualize the volume, concentration, and injection rate of Ultravist according to the specific dosing tables [see Dosage and Administration in Full Prescribing Information (sections 2.2, 2.3, 2.4)]. Consider factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; also consider extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
Visually inspect Ultravist for particulate matter and/or discoloration, whenever solution and container permit. Do not administer Ultravist if particulate matter (including crystals) and/or discoloration is observed or if containers are defective.
Use aseptic technique for all handling and administration of Ultravist.
Warm Ultravist to body temperature before administration.
Ultravist can be used with 0.9% Sodium Chloride Injection in a power injector suitable for simultaneous injection of contrast [see Dosage and Administration in Full Prescribing Information (section 2.3)]. However, do not mix or inject Ultravist in intravenous administration lines containing other drugs or total nutritional admixtures.
Discard any unused portion remaining in the single-dose container following initial use.

Grams of Iodine Administered
Volume	Ultravist Concentrations (mg Iodine per mL)
mL	300	370
10	3	3.7
20	6	7.4
30	9	11.1
40	12	14.8
50	15	18.5
60	18	22.2
70	21	25.9
80	24	29.6
90	27	33.3
100	30	37
110	33	40.7
120	36	44.4
130	39	48.1
140	42	51.8
150	45	55.5
160	48	59.2

Available Presentations

Ultravist Injection is available as a stable, ready-to-use aqueous solution of iopromide in vials or bottles in concentrations of 300 mg Iodine per mL, and 370 mg Iodine per mL. Ultravist is available in a number of vial sizes, including 500 and 200 mL Imaging Bulk Package.

Color-coded vials for easy identification of concentration
Integrated hanger labels
Clear glass vials/bottles for examination of product clarity
Peel-off product identification labels
Imaging Bulk Package offers 10-hour stand time, allowing flexibility to use doses as needed
Imaging Bulk Package is only to be used in a room designated for radiological procedures that involve intravascular administration of a contrast agent

For more information on reimbursement and purchasing options, click here.

SINGLE-DOSE GLASS VIALS (mL)	Vial Size (mL)	NDC Code	McKesson Material Number
300 mg Iodine per mL Boxes of 10	50	(NDC 50419-344-05)	1731355
	100	(NDC 50419-344-10)	1732957
	150	(NDC 50419-344-15)	1737550
370 mg Iodine per mL Boxes of 10	50	(NDC 50419-346-05)	1761378
	100	(NDC 50419-346-10)	1761600
	150	(NDC 50419-346-15)	1761808

IMAGING BULK PACKAGES (mL)	Vial Size (mL)	NDC Code	McKesson Material Number
300 mg Iodine per mL 500 mL Boxes of 8 200 mL Boxes of 10	200	(NDC 50419-344-23)	3045903
	500	(NDC 50419-344-65)	3045861
370 mg Iodine per mL 500 mL Boxes of 8 200 mL Boxes of 10	200	(NDC 50419-346-28)	3045937
	500	(NDC 50419-346-65)	3045879

Ultravist 370: Our Customized Offering to complement Evolving Clinical Protocols

Contrast administration timing is an important part of diagnostic efficacy with today’s fast-paced multidetector CT scanners

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