ISOVUE® (iopamidol injection)
Trust experience, choose confidence 1, 2, 3
Bracco was proud to launch the first ready-to-use non-ionic contrast agent, Isovue®, in 1981. This agent helped consolidate Bracco, as a global leader in the X-Ray contrast media market and research. Since the launch of Isovue® in 1981 many other non-ionic compounds have been made available, however, Isovue® remains the non-ionic agent of choice for thousands of clinicians world-wide. Isovue® is sold in more than 80 countries through affiliates, partners, distributors and licensees 1.
Its long history and unique physicochemical properties 2 have gained Isovue® many unique distinctions, including:
- The first ready-to-use non-ionic agent with the 370 mg/mL concentration 1
- The subject of over 2000 scientific publications 3
- Administered in over 400 million doses 1
- Approved in a wide range of indications (including pediatric), concentrations and volumes 2
- A proven safety profile 4, 5
- The advent of MDCT and new CT applications (cardiac, vascular, perfusion, etc) required clinicians to adjust their contrast protocols in particular in terms of volume, concentration and administration rate. Many renowned experts strongly promote the use of high concentration non-ionic agents in an effort to best exploit contrast utilization 6. The use of high concentration best matches the speed and power of multi-slice scanners, providing earlier, higher and shorter enhancement peak.
- Furthermore, Isovue® has proven to be well tolerated in many study cohorts. In particular, in renally-impaired patients. Two large comparative studies show that the risk of CIN (Contrast Induced Nephropathy), when the highly concentrated Iopamiro-370 is used in CT or during catheter endovascular procedures even in a subset of patients with diabetes, is not statistically different from that of iodixanol-320 4, 5, which provides inferior enhancement in first pass MDCT 7.
- The efficacy of high iodine concentration and the positive results even in patients at risk of developing CIN make Isovue® particularly indicated also for intra-arterial use in angiography and cardiangiography procedures where the volume of contrast and the risk of renal complications are highest 5.
1 Bracco Internal Data
2 Iopamidol SPC
3 PubMed database
4 Contrast-induced nephropathy in patients with chronic kidney disease undergoing computed tomography: a double-blind comparison of iodixanol and iopamidol.
Barrett BJ, Katzberg RW, Thomsen HS, Chen N, Sahani D, Soulez G, Heiken JP, Lepanto L, Ni ZH, Ni ZH, Nelson R.Invest Radiol. 2006 Nov;41(11):815-21. Erratum in: Invest Radiol. 2007 Feb;42(2):94. Ni, Zhao-hui [added].
5 Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease.
Solomon RJ, Natarajan MK, Doucet S, Sharma SK, Staniloae CS, Katholi RE, Gelormini JL, Labinaz M, Moreyra AE; Investigators of the CARE Study.Circulation. 2007 Jun 26;115(25):3189-96. Epub 2007 Jun 11
6 Aortic and hepatic enhancement and tumor-to-liver contrast: analysis of the effect of different concentrations of contrast material at multi-detector row helical CT.
Awai K, Takada K, Onishi H, Hori S.Radiology. 2002 Sep;224(3):757-63.
7 A comparison of the efficacy and safety of iopamidol-370 and iodixanol-320 in patients undergoing multidetector-row computed tomography.
Sahani DV, Soulez G, Chen KM, Lepanto L, Xu JR, Nelson RC, Grazioli L, Vanzulli A, Heiken JP; Investigators of the IMPACT Study.Invest Radiol. 2007 Dec;42(12):856-61.
1 Hepatic enhancement in multiphasic contrast-enhanced MDCT: comparison of high- and low-iodine-concentration contrast medium in same patients with chronic liver disease.
Furuta A, Ito K, Fujita T, Koike S, Shimizu A, Matsunaga N.AJR Am J Roentgenol. 2004 Jul;183(1):157-62.
2 Nephrotoxicity of iopamidol in pediatric, adolescent, and young adult patients who have undergone allogeneic bone marrow transplantation.
Haight AE, Kaste SC, Goloubeva OG, Xiong XP, Bowman LC.Radiology. 2003 Feb;226(2):399-404.
3 Renal effects of contrast media in diabetic patients undergoing diagnostic or interventional coronary angiography.
Hardiek KJ, Katholi RE, Robbs RS, Katholi CE.J Diabetes Complications. 2008 May-Jun;22(3):171-7. Epub 2008 Apr 16.
4 Significant coronary artery stenosis: comparison on per-patient and per-vessel or per-segment basis at 64-section CT angiography.
Herzog C, Zwerner PL, Doll JR, Nielsen CD, Nguyen SA, Savino G, Vogl TJ, Costello P, Schoepf UJ.Radiology. 2007 Jul;244(1):112-20.
5 Determining contrast medium dose and rate on basis of lean body weight: does this strategy improve patient-to-patient uniformity of hepatic enhancement during multi-detector row CT?
Ho LM, Nelson RC, Delong DM.Radiology. 2007 May;243(2):431-7.
6 High-dose administration of nonionic contrast media: a retrospective review.
Rosovsky MA, Rusinek H, Berenstein A, Basak S, Setton A, Nelson PK.Radiology. 1996 Jul;200(1):119-22.
7 Comparison of enhancement, image quality, cost, and adverse reactions using 2 different contrast medium concentrations for routine chest CT on 16-slice MDCT.
Setty BN, Sahani DV, Ouellette-Piazzo K, Hahn PF, Shepard JA.J Comput Assist Tomogr. 2006 Sep-Oct;30(5):818-22.
8 Iohexol, ioxaglate and iopamidol in coronary angiography. A double-blind comparative study of 300 patients.
Soiva M, Hekali P, Keto P, Karumo J, Salonen O, Heikkilä J.Australas Radiol. 1991 May;35(2):109-11.
9 Early and late reactions after the use of iopamidol 340, ioxaglate 320, and iodixanol 320 in cardiac catheterization.
Sutton AG, Finn P, Grech ED, Hall JA, Stewart MJ, Davies A, de Belder MA.Am Heart J. 2001 Apr;141(4):677-83.
10 A prospective, randomized trial to determine the early and late reactions after the use of iopamidol 340 (Niopam) and iobitridol 350 (Xenetix) in cardiac catheterization.
Vijayalakshmi K, Williams D, Wright RA, Hall JA, Harcombe AA, Linker NJ, Stewart MJ, Davies A, de Belder MA.J Invasive Cardiol. 2004 Dec;16(12):707-11.
| Product | Product SKU | Internal Code | Description |
| X-RAY - NON-IONIC | |||
|
ISOVUE 200 lopamidol injection, 41% |
131482 | 700397 | 10x20 mL vials |
| 131484 | 704306 | 10x100 mL vials | |
| 131484 | 704308 | 10x200 ml vials | |
|
ISOVUE 300 lopamidol injection, 61% |
131586 | 700416 | 10x15 mL vials |
| 131580 | 704300 | 10x50 mL vials | |
| 131584 | 704302 | 10x100 mL vials | |
| 131587 | 704303 | 10x150 mL vials | |
| 131543 | 704309 | 10x200 mL bottles | |
| 131589 | 704313 | 6x500 mL bottles | |
|
ISOVUE 370 lopamidol injection, 76% |
131680 | 704301 | 10x50 mL vials |
| 131684 | 704307 | 10x100 mL vials | |
| 131687 | 704304 | 10x150 mL vials | |
| 131643 | 704312 | 10x200 mL bottles | |
| 131689 | 704311 | 6x500 mL bottles | |
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DISCLAIMER
For any product or type of product, whether a drug or device, referenced in this website, physicians should carefully review the product's package insert, instructions for use, or user manual prior to patient administration to ensure proper utilization of the product. The Core Summaries of Product Characteristics for the main Bracco Imaging products are available on line, however; please consult your full locally approved information prior to administration.