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

  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},
  volume={23 Suppl 1},
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… 
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
Editor’s Highlight: In Utero Exposure to Gadolinium and Adverse Neonatal Outcomes in Premature Infants
Gadolinium use during pregnancy is unlikely to be associated with adverse effects in infants during the neonatal period, and there are no adverse effects on renal function or other common outcomes including degree of prematurity.
MRI in Pregnancy and Precision Medicine: A Review from Literature
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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.
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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.
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.
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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
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.