Toxicological safety evaluation of gadobenate dimeglumine 0.5 M solution for injection (MultiHance), a new magnetic resonance imaging contrast medium.

@article{Morisetti1999ToxicologicalSE,
  title={Toxicological safety evaluation of gadobenate dimeglumine 0.5 M solution for injection (MultiHance), a new magnetic resonance imaging contrast medium.},
  author={Alberto Morisetti and Simona Bussi and Piero Tirone and Christoph de Ha{\"e}n},
  journal={Journal of computer assisted tomography},
  year={1999},
  volume={23 Suppl 1},
  pages={
          S207-17
        }
}
OBJECTIVE To support the clinical use of gadobenate dimeglumine for injection as an intravascular magnetic resonance imaging contrast medium through an extensive battery of toxicological safety studies. METHODS Single and multiple dose toxicity, reproduction and mutagenicity assessments were carried out in rodents and non-rodents. RESULTS Initial adverse clinical signs in monkeys were associated with a systemic exposure 34 times higher than that found in humans after 0.1 mmol/kg gadobenate… 
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Toxicological assessment of gadolinium release from contrast media.
  • S. Bussi, X. Fouillet, A. Morisetti
  • Medicine, Biology
    Experimental and toxicologic pathology : official journal of the Gesellschaft fur Toxikologische Pathologie
  • 2007
Non‐clinical assessment of safety and gadolinium deposition after cumulative administration of gadobenate dimeglumine (MultiHance®) to neonatal and juvenile rats
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A literature review focusing on contrast and non-contrast MRI use during pregnancy found that long circulating liposomal nanoparticle-based blood-pool gadolinium contrast agents that do not penetrate the placental barrier and therefore do not expose the fetus to the contrast agent during pregnancy, preserving it from any hypothetical risks.
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Clinicians, radiologists, and patients should be aware of the most up‐to‐date data pertaining to the risks of GBCA administration and gadolinium deposition and toxicity, with a special focus on NSF.
Bile-Tagged 3D Magnetic Resonance Colonography After Exclusive Intravenous Administration of Gadobenate Dimeglumine, a Contrast Agent with Partial Hepatobiliary Excretion
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This new diagnostic procedure will enable not only morphological assessment of the colon but also functional and pathophysiological studies on the transport kinetics of bile and stool without any preparation of the patient.
The use of iodinated and gadolinium contrast media during pregnancy and lactation
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The very small potential risk associated with absorption of contrast medium may be considered insufficient to warrant stopping breast-feeding for 24 h following either iodinated or gadolinium contrast agents.
Placental perfusion MR imaging with contrast agents in a mouse model.
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Placental perfusion can be calculated by using dynamic contrast-enhanced MR imaging with contrast agents in a mouse model, as shown in this mouse model.
Placental perfusion and permeability: simultaneous assessment with dual-echo contrast-enhanced MR imaging in mice.
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Placental perfusion and permeability can be measured in vivo by using high gadolinium doses and a dual-echo MR imaging sequence, as assessed in mice with magnetic resonance (MR) imaging.
Contrast-enhanced MRI of the inner ear after intratympanic injection of meglumine gadopentetate or gadodiamide hydrate
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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.
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