Product Highlights
The clear choice for MRI imaging
- The leading nonionic MRI contrast medium1
- Rapid bolus injection rates2
- Proven safe and effective in both standard and cumulative dose options3
- Low viscosity2 eases delivery with fine-gauge needles for rapid injections
- Wide range of indications, including pediatric CNS and pediatric body2
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Flexible packaging options offering flexibility and ease of use.
Product Description
OMNISCAN was launched in the U.S. in 1993 to provide contrast enhancement of the central nervous system (CNS) to detect lesions of the brain, spinal cord, and associated tissues. OMNISCAN has since received approval for adult body and high-dose CNS indications, and pediatric CNS and body indications. OMNISCAN comes in different sizes to accommodate the most commonly performed procedures, and it is also available in prefilled syringes and in Prefill Plus™, first needle-free device of its kind approved by the FDA for use in magnetic resonance imaging (MRI).
References: 1. Data on file, Amersham Health. 2. OMNISCAN
Prescribing Information. 3. Rosen BR, Aronen H, Muhonen M, Yuh WTC. Phase
III open-label comparative study of OMNISCAN (0.1 and 0.3 mmol/kg) for
magnetic resonance imaging of the brain and spine.
WARNING: NOT FOR INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
NOT FOR INTRATHECAL USE
Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits.
NSF
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration. |
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The most frequent adverse events observed during OMNISCAN clinical trials in 1,369 patients at doses between 0.025 and 0.3 mmol/kg were headache, dizziness, and nausea. The majority of these adverse events were of mild to moderate intensity. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, or cardiovascular reactions, or other idiosyncaratic reactions, should always be considered, especially in those patients with a known clinical hypersensitivity, a history of asthma, or other allergic respiratory disorders. Since OMNISCAN is cleared from the body by glomerular filtration, caution should be exercised in patients with impaired renal function.
Asymptomatic, transitory changes in serum iron have been observed. The clinical significance is unknown.
Omniscan interferes with serum calcium measurements with some colorimetric (complexometric) methods commonly used in hospitals, resulting in serum calcium concentrations lower than the true values. Thus, it is recommended not to use such methods for 12-24hours after administration of Omniscan. If such measurements are necessary, the use of other methods is recommended. All patients in whom this effect was observed remained asymptomatic. |
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