TOXICOLOGICAL SAFETY ASSESSMENT OF IOMEPROL, A NEW X-RAY CONTRAST AGENT

被引:36
作者
MORISETTI, A [1 ]
TIRONE, P [1 ]
LUZZANI, F [1 ]
DEHAEN, C [1 ]
机构
[1] BRACCO IND CHIM SPA,PRECLIN RES,DIV RES & DEV,I-20134 MILAN,ITALY
关键词
CONTRAST MEDIA; IONIC AND NONIONIC; TOXICOLOGY; SAFETY;
D O I
10.1016/0720-048X(94)90091-4
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
The toxicology of pharmaceutical formulations of iomeprol, a new nonionic iodinated radiographic contrast agent, was studied in rodents (mice, rats and guinea-pigs) and non-rodents (rabbits and dogs). When injected intravascularly the acute toxicity of iomeprol, both in terms of median lethal dose and symptoms, was comparable to that of analogous triiodinated nonionic contrast media (CM). Intravenous daily dosing for 4 weeks showed that iomeprol was well tolerated at doses as high as the maximum dose anticipated for clinical use. Moreover, the compound did not possess reproductive, developmental, or genetic toxicity. Tissue tolerability was completely superimposable on those of reference CM such as iopamidol and iohexol. Finally, no antigenic potential was detected either in mice or guinea-pigs. These favourable toxicological characteristics bode well for iomeprol as an intravascular radiographic contrast agent.
引用
收藏
页码:S21 / S31
页数:11
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