Ox Brochure Inside Pages.indd
Transcription
Ox Brochure Inside Pages.indd
Are you seeing the whole picture? The whole picture on osmolality Lowest osmolality of all monomers • The threshold of vascular pain was determined to be approximately 700 to 750 mOsms3* • Low osmolality improves patient comfort and minimizes patient movement – In a randomized, parallel, double-blind, controlled study of 112 patients, OXILAN® was well tolerated on patient measures of pain and warmth2 Compare the osmolality of OXILAN® 3001 Monomers 700 Dimers 672 616 600 607 651 600 (mOsm/kgH2O) 585 500 400 300 290 200 100 0 OXILAN® 300 Omnipaque™ 300 Isovue® 300 Ultravist® 300 Optiray® 300 Hexabrix® 320 Visipaque™ 320 Compare the osmolality of OXILAN® 3501 Monomers Dimers 900 844 800 (mOsm/kgH2O) 700 796 774 792 695 600 600 500 400 300 290 200 100 0 OXILAN® 350 Omnipaque™ 350 Isovue® 370 Ultravist® 370 Optiray® 350 Hexabrix® 320 Visipaque™ 320 *The clinical significance of this data is not known. OXILAN® gives you both patient comfort and The whole picture on viscosity Lowest viscosity of all the monomers at 350-370 concentration • Low viscosity allows for easy injection through small diameter catheters4 • Low viscosity allows for high-speed injection6 • Low viscosity provides better flow through small blood vessels and capillaries5 Compare the viscosity of OXILAN® 3001 Monomers Dimers Monomers Dimers 12 30 11.8 8 20 15 cPs at 37° C cPs at 20° C 10 26.6 25 15.7 10 11.8 9.4 8.8 9.2 Isovue® 300 Ultravist® 300 6.3 5.5 5.1 4 4.9 4.7 2 5 0 7.5 6 0 OXILAN® Omnipaque™ 300 300 Hexabrix® 320 OXILAN® Omnipaque™ Isovue® 300 300 300 Visipaque™ 320 Ultravist® 300 Optiray® 300 Hexabrix® 320 Visipaque™ 320 Compare the viscosity of OXILAN® 3501 Monomers Dimers Monomers Dimers 12 30 11.8 26.6 25 10 10.4 20 15 20.4 20.9 16.3 cPs at 37° C cPs at 20° C 9.4 22 15.7 10 9 8.1 7.5 6 4 2 5 0 8 10 OXILAN® Omnipaque™ 350 350 Isovue® 370 Ultravist® 370 Hexabrix® 320 Visipaque™ 320 0 OXILAN® Omnipaque™ 350 350 Isovue® 370 Ultravist® 370 Optiray® 350 Hexabrix® 320 Visipaque™ 320 • 39% less viscosity than Visipaque and 20% less viscosity than Omnipaque at 20°C the visibility you need (ioxilan) Injection Compare and Contrast Ox Brochure Inside Pages.indd 4 2/25/2009 5:08:54 PM The whole picture on safety Renal Safety The OXILAN® balance of low viscosity and low osmolality may help reduce the risk of renal complications* • Low osmolar contrast media (CM) are as safe as iso-osmolar for contrast-induced nephropathy (CIN), as ICON and CARE studies have shown7 • Hydration plays a major role in at least limiting the incidence of CIN8 • Osmolality is not a factor in decreasing renal blood flow or glomerular filtration9* • High viscosity CM can be responsible for hypoperfusion of the inner medulla and cortex in animal studies10* • High viscosity can significantly reduce renal blood flow from baseline10* • Low osmolar dimeric CM may have a greater potential for cytotoxic effects on proximal renal tubular cells than monomeric CM11* (in vitro study) Arrhythmia OXILAN® contains sodium (9 mmol/L Na) with a citrate buffer • The addition of sodium to CM solutions has been shown to reduce the risk of ventricular fibrillation (VF) in animal studies12* – OXILAN® produced a much lower incidence of VF compared to other nonionic monomers studied (ioversol12, iomeprol12, iopromide12, iohexol13) Hemodynamics In these studies vs iohexol, OXILAN®: • significantly decreased platelet aggregation and activation14 (clinical study, N=37) • had less effect on the endothelium15* (animal study, electron micrograph of aortic rings) • had minimal effect on mean blood pressure and heart rate16* (animal study) • had no negative inotropic effect16* (animal study) *The clinical significance of this data is not known. Please see full Prescribing Information for complete disclosure of safety risks and warnings. Ox Brochure Inside Pages.indd 1 2/25/2009 5:08:46 PM The whole picture on the unique molecular structure The molecular structure of OXILAN® provides both patient comfort and the visibility you need Hydrophilic Group • Increases solubility which can contribute to rapid renal clearance3 • Reduces binding with other molecular structures, which may promote endothelial tolerance3 Hydrophobic Region • Promotes “transient molecular aggregation” of the molecules, reducing osmolality3 • Achieves lower osmolality at diagnostically useful concentrations3 (ioxilan) Injection Compare and Contrast Ox Brochure Inside Pages.indd 2 2/25/2009 5:08:52 PM The whole picture on the OXILAN® balance balanced with The low viscosity characteristic of a monomer The low osmolality provided by the hydrophobic region of the molecule Viscosity is determined by the size of the molecules in solution Osmolality is determined by the number of particles in solution OXILAN® has been used in more than 4.5 million patients since 19961 Indications OXILAN® is available in 2 concentrations for the following indications: Intra-arterial OXILAN® (ioxilan) Injection (300 mgI/mL) is indicated for cerebral arteriography OXILAN® (ioxilan) Injection (300 mgI/mL) and OXILAN® (ioxilan) Injection (350 mgI/mL) are indicated for excretory urography and contrast enhanced computed tomographic (CECT) imaging of the head and body OXILAN® (ioxilan) Injection (350 mgI/mL) is indicated for coronary arteriography and left ventriculography, visceral angiography, aortography and peripheral arteriography Intravenous Ox Brochure Inside Pages.indd 3 2/25/2009 5:08:53 PM d References: 1. Data on file. Guerbet LLC. 2. McIntosh CL, Reed R. Ioxilan injection: an overview and results of aortofemoral arteriography study. Invest Radiol. 1994;29 Suppl 2:S40-S42. 3. Sovak M. The need for improved contrast media. Ioxilan: updating design theory. Invest Radiol. 1988;23 Suppl 1:S79-S83. 4. Roth R, Akin M, Deligonul U, et al. Influence of radiographic contrast media viscosity to flow through coronary angiographic catheters. Cathet Cardiovasc Diag. 1991;22:290-294. 5. Dawson P, Clauss W. Contrast media in practice: questions and answers. Springer-Verlag Berlin Heidelberg. 1999. 6. Eloy R, Corot C, Belleville J. Contrast media for angiography: physicochemical properties, pharmacokinetics and biocompatibility. Clin Mater. 1991;7:89-197. 7. O’Riordan M. No difference in the incidence of contrast-induced nephropathy with iso-osmolar or low-osmolar contrast agent. HeartWire>News. 25 October 2006. <http://www.theheart.org/article/749937.do>. 8. Bettmann MA. Contrast agents and contrast-induced nephropathy: are there differences between specific agents? The J of Invas Cardiol. 2006;18 Suppl A:13A-15A. 9. Persson PB, Hansell P, Liss P. Pathophysiology of contrast medium-induced nephropathy. Kidney Intl. 2005;68:14-22. 10. Lancelot E, Idée JM, Couturier V, et al. Influence of the viscosity of iodixanol on medullary and cortical blood flow in the rat kidney: a potential cause of nephrotoxicity. J Appl Toxicol. 1999;19:341-346. 11. Heinrich MC, Kuhlmann MK, Grgic A, et al. Cytotoxic effects of ionic high-osmolar, nonionic monomeric, and nonionic iso-osmolar dimeric iodinated contrast media on renal tubular cell in vitro. Radiology. 2005;235:843-849. 12. Misumi K, Tateno O, Fujiki M, et al. The risk of contrast media-induced ventricular fibrillation is low in canine coronary arteriography with ioxilan. J Vet Med Sci. 2000;62(4):421-426. 13. Sakamoto H, Tabuchi T, Kamimura T, et al. The effects of ioxilan, a new non-ionic contrast medium, on the cardiovascular system. J Jap Coll Angiol. 1992;32(12). 14. Ogawa T, Fujii S, Urasawa K, et al. Effects of nonionic contrast media on platelet aggregation. Jpn Heart J. 2001;42:115-124. 15. Schneider KM, Ham KN, Friedhuber A, et al. Functional and morphologic effects of ioxilan, iohexol, and diatrizoate on endothelial cells. Invest Radiol. 1988;23 Suppl 1:S147-S149. 16. Nakamura H, Kurata M, Haruta K, et al. Effects of ionic and nonionic contrast media on cardiohemodynamics and quality of radiographic image during canine angiography. J Vet Med Sci. 1994;56:91-96. (ioxilan) Injection Compare and Contrast References: 1. Data on file. Guerbet LLC. 2. McIntosh CL, Reed R. Ioxilan injection: an overview and results of aortofemoral arteriography study. Invest Radiol. 1994;29 Suppl 2:S40-S42. 3. Sovak M. The need for improved contrast media. Ioxilan: updating design theory. Invest Radiol. 1988;23 Suppl 1:S79-S83. 4. Roth R, Akin M, Deligonul U, et al. Influence of radiographic contrast media viscosity to flow through coronary angiographic catheters. Cathet Cardiovasc Diag. 1991;22:290-294. 5. Dawson P, Clauss W. Contrast media in practice: questions and answers. Springer-Verlag Berlin Heidelberg. 1999. 6. Eloy R, Corot C, Belleville J. Contrast media for angiography: physicochemical properties, pharmacokinetics and biocompatibility. Clin Mater. 1991;7:89-197. 7. O’Riordan M. No difference in the incidence of contrast-induced nephropathy with iso-osmolar or low-osmolar contrast agent. HeartWire>News. 25 October 2006. <http://www.theheart.org/article/749937.do>. 8. Bettmann MA. Contrast agents and contrast-induced nephropathy: are there differences between specific agents? The J of Invas Cardiol. 2006;18 Suppl A:13A-15A. 9. Persson PB, Hansell P, Liss P. Pathophysiology of contrast medium-induced nephropathy. Kidney Intl. 2005;68:14-22. 10. Lancelot E, Idée JM, Couturier V, et al. Influence of the viscosity of iodixanol on medullary and cortical blood flow in the rat kidney: a potential cause of nephrotoxicity. J Appl Toxicol. 1999;19:341-346. 11. Heinrich MC, Kuhlmann MK, Grgic A, et al. Cytotoxic effects of ionic high-osmolar, nonionic monomeric, and nonionic iso-osmolar dimeric iodinated contrast media on renal tubular cell in vitro. Radiology. 2005;235:843-849. 12. Misumi K, Tateno O, Fujiki M, et al. The risk of contrast media-induced ventricular fibrillation is low in canine coronary arteriography with ioxilan. J Vet Med Sci. 2000;62(4):421-426. 13. Sakamoto H, Tabuchi T, Kamimura T, et al. The effects of ioxilan, a new non-ionic contrast medium, on the cardiovascular system. J Jap Coll Angiol. 1992;32(12). 14. Ogawa T, Fujii S, Urasawa K, et al. Effects of nonionic contrast media on platelet aggregation. Jpn Heart J. 2001;42:115-124. 15. Schneider KM, Ham KN, Friedhuber A, et al. Functional and morphologic effects of ioxilan, iohexol, and diatrizoate on endothelial cells. Invest Radiol. 1988;23 Suppl 1:S147-S149. 16. Nakamura H, Kurata M, Haruta K, et al. Effects of ionic and nonionic contrast media on cardiohemodynamics and quality of radiographic image during canine angiography. J Vet Med Sci. 1994;56:91-96. (ioxilan) Injection Compare and Contrast For more information, please call 877.729.6679 or visit our Web site at www.guerbet-us.com © 2008 Guerbet LLC Oxilan is a registered trademark of Guerbet LLC. Other brand names are trademarks or registered trademarks of their respective owners. Please see accompanying full Prescribing Information Available in 300 and 350 mgI/mL latex-free bottles Single Dose: 50 mL, 100 mL, 150 mL and 200 mL Pharmacy Bulk Package: 500 mL • Excellent hemodynamic profile • Contains sodium citrate to reduce the risk of ventricular fibrillation • Unique molecular structure contributes to patient comfort and rapid renal clearance • Lowest osmolality of all monomers contributes to patient comfort Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting. Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally. NOT FOR INTRATHECAL USE • Low viscosity for easy administration All OXILAN® bottles are manufactured latex-free.1 OXILAN® looks like the right choice When you see the whole picture, Product Information OXILAN® (ioxilan) Injection Nonionic Contrast Agent is a water-soluble, triiodinated contrast medium administered by intravascular injection to enhance radiographic visualization and diagnosis.