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Download the GASTROGRAFIN Brochure From a trusted leader of oral contrast media... MR Suite CT Suite I/Dx Suite Lemon-flavored For specific GI imaging applications... A trusted solution for over 50 years1 Committed to Science, Committed to You.™ Clinical efficacy and safety help support confidence2 Lemon-flavored Gastrografin (diatrizoate meglumine and diatrizoate sodium solution USP) is a palatable, water-soluble, iodinated, radiopaque contrast medium that can be used: • As an alternative to non–water-soluble barium sulfate agents • As an adjunct to IV contrast enhancement in computed tomography (CT) of the torso • In various bowel imaging applications, including CT colonography INDICATIONS AND USAGE Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water soluble, is not feasible or is potentially dangerous. Gastrografin may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to Gastrografin or any of its components. IMPORTANT SAFETY INFORMATION Not for parenteral use; do not inject. Oral or rectal administration only. It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Please see accompanying full Prescribing Information. 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. GASTROGRAFIN® vs OMNIPAQUE™ (iohexol injection) 350: The physicochemical difference is minimal when diluted for use in CT2-4 VISCOSITY* OSMOLALITY* BOTTLED WATER BOTTLED WATER DILUENT AS IS WATER WATER OMNIPAQUE 350 TAP WATER TAP WATER GASTROGRAFIN FAT-FREE MILK FAT-FREE MILK 2% REDUCED-FAT MILK MILK 2% REDUCED-FAT MILK MILK WHOLE MILK WHOLE MILK FRESH/CONCENTRATE FRESH/CONCENTRATE APPLE JUICE APPLE JUICE CONCENTRATE CONCENTRATE CLASSIC ORANGE CLASSIC ORANGE CRYSTAL LIGHT® CRYSTAL LIGHT® LEMONADE LEMONADE REGULAR REGULAR GINGER ALE GINGER ALE DIET DIET 0.0 0.5 1.0 1.5 2.0 2.5 0 100 200 300 400 500 600 700 800 Viscosity (mPa•s) @ 37°C AVERAGE (n=3) Osmolality (m0sm/kg) @ 37°C Effect of dilution for use in CT2-4 Gastrografin and Omnipaque 350 were diluted 1:40 in water, milk, apple juice, Crystal Light®, and ginger ale (diluents typically used in clinical CT practice during oral administration for GI lumen enhancement). • Upon the 1:40 dilution of both contrast agents with the various drinks mentioned above, the diluent contributed to the final osmolality and viscosity of the administered drink • For each base diluent, the addition of the contrast agent resulted in a minimal effect on the overall osmolalities and viscosities of the solutions *An osmolality and viscosity comparison of the properties of Gastrografin vs Omnipaque 350 when mixed with various diluents for use in CT. As packaged and labeled, the osmolality of Gastrografin is about 2.5x greater than that of Omnipaque 350. The trusted solution for specific areas of GI imaging... Ready-to-use gives you options ORDERING INFORMATION Gastrografin NDC Number (diatrizoate meglumine and diatrizoate sodium solution USP) Twenty-four 30 mL bottles 0270-0445-35 Twelve 120 mL bottles 0270-0445-40 Meet your GI imaging needs with Gastrografin • Water-soluble, iodinated contrast for fluoroscopy and body imaging, including esophagus, stomach, and proximal small intestine, plus colon CT colonography and virtual colonoscopy • Convenient administration and single-unit dosing • No powder to reconstitute INDICATIONS AND USAGE Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water soluble, is not feasible or is potentially dangerous. Gastrografin may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to Gastrografin or any of its components. IMPORTANT SAFETY INFORMATION Not for parenteral use; do not inject. Oral or rectal administration only. It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Please see accompanying full Prescribing Information. 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. References: 1. Gastrografin® launched in the United States in 1958. 2. Study No. BRU-TDC-W5256.08 Market-O012592-1.0 An osmolality and viscosity comparison of Gastrografin® versus Omnipaque 350 with various base diluents. Comissioned by Bracco Diagnostics. January 2009. 3. Gastrografin® (diatrizoate meglumine and diatrizoate sodium solution USP) full Prescribing Information. Bracco Diagnostics Inc.; 2011. 4. Omnipaque™ (iohexol injection) full Prescribing Information. GE Healthcare; 2010. Gatrografin is a registered trademark of E-Z-EM, Inc., a wholly-owned subsidiary of Bracco Diagnostics Inc. Omnipaque is a trademark of GE Healthcare. Crystal Light is a registered trademark of Kraft Foods. Distributed by: Manufactured by: Customer Service: Bracco Diagnostics Inc. E-Z-EM Canada Inc. 1-877-BRACCO 9 (1-877-272-2269) 259 Prospect Plains Road, Building H 11065 Louis H. Lafontaine Monroe Township, NJ 08831 USA Anjou, Québec, H1J-2Z4 Professional Services: Canada 1-800-257-5181 (option 1) Phone: (800) 631-5245 Fax: (609) 514-2424 © 2014 Bracco Diagnostics Inc. All Rights Reserved. 14-072914 Committed to Science, Committed to You.™.
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