| Safety of ProHance in special populations. | |
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MedLine Citation:
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PMID: 9370552 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The safety profile of ProHance in special populations was evaluated by analyzing data extracted from the database of phase I-III studies which included data on 2,656 ProHance injections of which 119 in pediatric patients, 814 in elderly patients and 30 in patients with varying degrees of renal impairment (moderate, severe or end stage requiring hemodialysis). ProHance was administered at doses ranging from 0.1 mmol/kg to 0.3 mmol/kg and was found to be safe in all patient populations irrespective of age and of pre-existing renal impairment. There appeared to be no correlation between incidence of adverse events and dose level in these special populations and the higher dose level of 0.3 mmol/kg could be safely administered also to patients with end stage renal disease requiring hemodialysis, from whom the contrast medium was rapidly and efficiently dialysed. |
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Authors:
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K Yoshikawa; A Davies |
Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: European radiology Volume: 7 Suppl 5 ISSN: 0938-7994 ISO Abbreviation: Eur Radiol Publication Date: 1997 |
Date Detail:
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Created Date: 1998-01-28 Completed Date: 1998-01-28 Revised Date: 2013-01-14 |
Medline Journal Info:
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Nlm Unique ID: 9114774 Medline TA: Eur Radiol Country: GERMANY |
Other Details:
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Languages: eng Pagination: 246-50 Citation Subset: IM |
Affiliation:
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Department of Radiology, Institute of Medical Science,University of Tokyo, Japan. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Child Child, Preschool Contrast Media* / adverse effects Female Gadolinium / adverse effects, diagnostic use* Heterocyclic Compounds / adverse effects, diagnostic use* Humans Infant Infusions, Intravenous Kidney Failure, Chronic / diagnosis*, therapy Magnetic Resonance Imaging / methods* Male Middle Aged Organometallic Compounds / adverse effects, diagnostic use* Safety |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Heterocyclic Compounds; 0/Organometallic Compounds; 0199MV609F/gadoteridol; 7440-54-2/Gadolinium |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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