Ultravist® (iopromide) injection
Ultravist®, an integral part of our CT portfolio, is a proven X-ray contrast medium with a broad range of FDA-approved indications.
A COMBINATION OF EXPERIENCE AND VERSATILITY FOR TODAY'S RADIOLOGY PRACTICE
- Studied in clinical trials
- Visualization rated good to excellent in 97% - 99% of Phase III Clinical Trial patients¹
- Assessment was based on evaluation of radiograph quality by rating visualization as excellent, good, poor, or no image for five intra-arterial and three intravenous procedures among 708 patients¹
- Used in more than 120 countries worldwide*
- Over 13 million vials sold in 2015†
- With a wide range of concentrations and packaging to support today's imaging applications¹
*Based on YTD January-August 2016 Bayer Internal Sales Data.²
†Based on 2015 Bayer Internal Sales Data.²
Reference: 1. Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals. 2. Data on File, 2016. Bayer HealthCare
As a proven X-ray contrast medium, Ultravist® has a broad range of indications for intravenous and intra-arterial uses:
- Intra-arterial Procedures¹
- - 300 mg Iodine per mL for cerebral arteriography and peripheral arteriography
- - 370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
- Intravenous Procedures¹
- - 240 mg Iodine per mL for peripheral venography
- - 300 mg Iodine per mL for excretory urography
- - 300 mg Iodine per mL and 370 mg Iodine per mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions
- - The usefulness of contrast enhancement for the investigation of the retrobulbar space of low grade or infiltrative glioma has not been demonstrated
Ultravist® is contraindicated for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Developed by Bayer Healthcare LLC, Ultravist® Injection was launched in Europe in 1985, and is now in its 30th year as a global brand. Ultravist® Injection is supported by Bayer HealthCare LLC, a world leader in diagnostics serving the radiology community and specialists worldwide.
Reference: 1. Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals.Back to top
The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.
- Cerebral Arteriography (300 mg Iodine per mL), Coronary Arteriography and Left Ventriculography (370 mg Iodine per mL), Peripheral Arteriography (300 mg Iodine per mL): see Table 1.
- Aortography and Visceral Angiography (370 mg Iodine per mL): Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.
Dosage Forms and Strengths
Ultravist® Injection is nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg Iodine per mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer. Ultravist Injection is available in three strengths:
- 240 mg Iodine per mL provides 498.72 mg/mL iopromide
- 300 mg Iodine per mL provides 623.4 mg/mL iopromide
- 370 mg Iodine per mL provides 768.86 mg/mL iopromide
- Visually inspect Ultravist® for particulate matter and/or discoloration, whenever solution and container permit. Do not administer Ultravist® if particulate matter and/or discoloration is observed.
- Determine the volume and concentration of Ultravist® Injection to be used, taking into account factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for Ultravist® Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of Ultravist® Injection below doses recommended has not been established.
- The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.
- Hydrate patients adequately prior to and following the administration of Ultravist® [see Warnings and Precautions in the Full Prescribing Information]
- Warming Ultravist® to body temperature shortly before administration may help improve tolerability and ease of injection
Reference: 1.Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals; 2015.Back to top
Formulation and Packaging
Ultravist® Injection is available as a stable, ready-to-use aqueous solution of iopromide in vials or bottles in concentrations of 240 Iodine per mL, 300 mg Iodine per mL, and 370 Iodine per mL. Ultravist® is available in a number of vial sizes, including the 500 mL Pharmacy 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
- Pharmacy bulk package offers industry-leading 10-hour stand time, allowing flexibility to use doses as needed
Committed to access and quality and expanding the tools that support clinical imaging
Uninterrupted access and high-quality supply are more important than ever. From our history of first-to-market products to our ongoing research, Bayer continuously invests in new technology to help meet the needs of the imaging community.
The synthesis and formulation of Ultravist® require expert knowledge and advanced technology.
Bayer invests in production sites to support availability and adherence to quality standards at every step, including:
- Established additional Ultravist® production line in Bergkamen, Germany to address increasing worldwide demand and maintain consistent supply
- Compliance with Good Manufacturing Practices (GMP)¹
Click here to view a video highlighting Bayer's contrast manufacturing facility.
From our history of first-to-market products to our on-going research, Bayer continuously invests in new technology to help meet the needs of the imaging community:
- Developed the first MR power injector in the U.S.
- Developed the first CT power injector in the U.S.
- Pioneered development in Radiation Dose and Contrast Dose Management informatics with consistent software upgrades every year
- Developed the first PET FDG infusion system in the U.S.
Reference: 1. Data on File, 2016. Bayer HealthCareBack to top
If you have a question about reimbursement, please contact the Reimbursement Support Hotline:
- Telephone: 1-800-423-7539
In today's cost-conscious healthcare environment, Bayer HealthCare LLC offers a comprehensive line of quality imaging products at competitive prices combined with highly regarded service and support. Knowing that purchasers have unique requirements, we do our best to provide creative yet competitive contracts that go beyond just meeting product needs. Additional purchasing resources are described below.
Bayer HealthCare LLC's partnership with McKesson Specialty Care Solutions (1-877-259-4624) combines Bayer's commitment to our customers with the drug distribution of McKesson, focused on delivering the right product to the right place at the right time. McKesson's reputation for reliable service makes them an ideal solution through which to source your Bayer HealthCare LLC imaging products.
Additional independent suppliers are listed below in alphabetical order.