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Omniscan (Gadodiamide) - Summary

 
 



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 [ see Warnings and Precautions ].

NSF:

  • Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer OMNISCAN to patients with:
      chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
    • acute kidney injury [see Contraindications (4) ].
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • Do not exceed the recommended OMNISCAN dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration [see Warnings and Precautions ].
 

OMNISCAN SUMMARY

OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection.

CNS (Central Nervous System)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [ see Clinical Studies ].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [ see Clinical Studies ].


See all Omniscan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Omniscan (Gadodiamide)

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Flexible future of point-of-care disease diagnostic
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The world-wide deployment of biomedical devices for health monitoring, point-of-care diagnostics and environmental sensing is hampered by their high cost that is not readily affordable for e.g.

more news >>

Published Studies Related to Omniscan (Gadodiamide)

Comparison of gadobenate dimeglumine and gadodiamide in the evaluation of spinal vascular anatomy with MR angiography. [2010.06]
BACKGROUND AND PURPOSE: Spinal MRA has been increasingly used to evaluate non-invasively the spinal cord vasculature. Our aim was to prospectively compare gadobenate dimeglumine with gadodiamide in the assessment of the normal spinal cord vasculature by using contrast-enhanced MRA, with the hypothesis that high T1 relaxivity gadolinium compounds may improve visualization of the intradural vessels... CONCLUSIONS: Improved image quality and vascular contrast enhancement of spinal MRA at 1.5T is achieved with high T1 relaxivity gadolinium contrast agents compared with conventional agents at equivalent doses.

Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial. [2010.02]
PURPOSE: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast-enhanced magnetic resonance angiography (MRA) in detecting hemodynamically relevant renal artery stenosis (RAS) when compared with intraarterial digital subtraction angiography (IA-DSA) as the gold standard... CONCLUSION: Gadodiamide administration at the labeled dose of 0.1 mmol/kg for contrast-enhanced MRA achieved equivalent results compared to IA-DSA in evaluation of RAS and was well tolerated.

Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. [2006.03]
PURPOSE: To prospectively evaluate accuracy of gadolinium-enhanced three-dimensional (3D) magnetic resonance (MR) angiography with gadodiamide and gadopentetate dimeglumine (0.1 mmol/kg), with intraarterial DSA as reference standard, for imaging abdominal and iliac arterial stenoses... CONCLUSION: Noninferiority of gadodiamide versus gadopentetate was verified based on the primary end point, which was accuracy for detection of the main stenosis with enhanced 3D MR angiography compared with DSA. Copyright RSNA, 2006.

Contrast-enhanced magnetic resonance angiography of the lower extremities: standard-dose vs. high-dose gadodiamide injection. [2005.04]
PURPOSE: To compare the efficacy and safety of two different doses (0.1 and 0.3 mmol/kg of body weight [BW]) of gadodiamide for contrast-enhanced magnetic resonance angiography (ce-MRA) of the lower extremities with intraarterial digital subtraction angiography (IA-DSA)... CONCLUSION: Ce-MRA with gadodiamide is safe and efficacious. Comparison of two different doses with IA-DSA as the standard of reference showed that the 0.3 mmol/kg dose is superior to the standard 0.1 mmol/kg dose with respect to contrast enhancement, vessel delineation, image quality, and detection of collaterals. However, the 0.1 mmol/kg dose was superior to the high dose in the grading of stenosis. Copyright 2005 Wiley-Liss, Inc.

Contrast-enhanced MRI of the inner ear after intratympanic injection of meglumine gadopentetate or gadodiamide hydrate. [2011.02]
CONCLUSION: The degree of contrast enhancement of the cochlea after intratympanic administration of meglumine gadopentetate (Gd-DTPA) or gadodiamide hydrate (Gd-DTPA-BMA) varies widely among patients with inner ear diseases. There was no morphological change in the stria vascularis after Gd-DTPA or Gd-DTPA-BMA was placed on the round window of guinea pigs. OBJECTIVES: We investigated the degree of contrast enhancement of the inner ear after intratympanic administration of ionized and nonionized gadolinium (Gd) contrast agents in patients with inner ear diseases. The inner ear toxicities of these agents were investigated in guinea pigs... CONCLUSION: The degree of contrast enhancement of the cochlea after intratympanic administration of meglumine gadopentetate (Gd-DTPA) or gadodiamide hydrate (Gd-DTPA-BMA) varies widely among patients with inner ear diseases. There was no morphological change in the stria vascularis after Gd-DTPA or Gd-DTPA-BMA was placed on the round window of guinea pigs. OBJECTIVES: We investigated the degree of contrast enhancement of the inner ear after intratympanic administration of ionized and nonionized gadolinium (Gd) contrast agents in patients with inner ear diseases. The inner ear toxicities of these agents were investigated in guinea pigs. METHODS: 3D-FLAIR MRI was conducted 1 day after the intratympanic injection of eightfold-diluted Gd-DTPA or Gd-DTPA-BMA in 73 patients with inner ear diseases. Gd enhancement of the basal turn of the cochlea was evaluated as the signal intensity (SI) ratio between the affected and nonaffected sides. In guinea pigs, nondiluted Gd-DTPA, Gd-DTPA-BMA or saline was placed on the round window for 1 h and the stria vascularis was observed using electron microscopy. RESULTS: The SI ratio ranged from 1.5 to 16.5 in the Gd-DTPA group and from 2.5 to 21 in the Gd-DTPA-BMA group. Electron microscopy showed no significant differences in the stria vascularis of guinea pigs in any of the groups.

more studies >>

Clinical Trials Related to Omniscan (Gadodiamide)

Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI) [Completed]
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.

A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging [Completed]
The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR) imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing. To this purpose, a conventional MR contrast medium (Gd-DTPA-BMA) will be used during an adenosine infusion (an approved substance which enlarges the arteries of the heart, so that the blood flow to the heart muscle increases). This magnetic resonance imaging technique will be compared with single photon emission computed tomography (SPECT), a well-established technique to detect this heart abnormalities. Both, cardiac MR and SPECT will be compared with invasive coronary angiography, a technique which directly visualized the heart vessels and narrowings of these (=standard of reference).

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer [Recruiting]
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.

more trials >>

Reports of Suspected Omniscan (Gadodiamide) Side Effects

Nephrogenic Systemic Fibrosis (229)Pain (163)Skin Induration (108)Skin Tightness (97)Mobility Decreased (94)Skin Hypertrophy (93)Oedema Peripheral (92)Anxiety (85)Pain in Extremity (80)Emotional Distress (79)more >>


Page last updated: 2016-04-29

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