rdf:type |
|
lifeskim:mentions |
|
pubmed:issue |
1
|
pubmed:dateCreated |
2000-12-5
|
pubmed:abstractText |
The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.
|
pubmed:language |
eng
|
pubmed:journal |
|
pubmed:citationSubset |
IM
|
pubmed:chemical |
|
pubmed:status |
MEDLINE
|
pubmed:month |
Jul
|
pubmed:issn |
1053-1807
|
pubmed:author |
pubmed-author:AndersonM WMW,
pubmed-author:BorelloJ AJA,
pubmed-author:BovaJ GJG,
pubmed-author:BrownJ JJJ,
pubmed-author:ChezmarJ LJL,
pubmed-author:DachmanA HAH,
pubmed-author:FederleM PMP,
pubmed-author:FenstermacherMM,
pubmed-author:FosterG SGS,
pubmed-author:FrancisI RIR,
pubmed-author:FreenyP CPC,
pubmed-author:HalfordH HHH,
pubmed-author:HarmonBB,
pubmed-author:HarmsS ESE,
pubmed-author:JohnsonC DCD,
pubmed-author:KenneyP JPJ,
pubmed-author:KlippensteinD LDL,
pubmed-author:LeeJ KJK,
pubmed-author:MattreyRR,
pubmed-author:MitchellD GDG,
pubmed-author:PelsangR ERE,
pubmed-author:SWARTJ AJA,
pubmed-author:SainoYY,
pubmed-author:SemelkaR CRC,
pubmed-author:TurnerD ADA,
pubmed-author:WeinrebJ CJC
|
pubmed:issnType |
Print
|
pubmed:volume |
12
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
Y
|
pubmed:pagination |
186-97
|
pubmed:dateRevised |
2006-11-15
|
pubmed:meshHeading |
pubmed-meshheading:10931579-Abdominal Pain,
pubmed-meshheading:10931579-Adult,
pubmed-meshheading:10931579-Aged,
pubmed-meshheading:10931579-Aged, 80 and over,
pubmed-meshheading:10931579-Cardiovascular Diseases,
pubmed-meshheading:10931579-Contrast Media,
pubmed-meshheading:10931579-Diagnosis, Differential,
pubmed-meshheading:10931579-Edetic Acid,
pubmed-meshheading:10931579-Female,
pubmed-meshheading:10931579-Humans,
pubmed-meshheading:10931579-Image Enhancement,
pubmed-meshheading:10931579-Injections, Intravenous,
pubmed-meshheading:10931579-Liver Cirrhosis,
pubmed-meshheading:10931579-Liver Neoplasms,
pubmed-meshheading:10931579-Magnetic Resonance Imaging,
pubmed-meshheading:10931579-Male,
pubmed-meshheading:10931579-Middle Aged,
pubmed-meshheading:10931579-Pain,
pubmed-meshheading:10931579-Pregnancy,
pubmed-meshheading:10931579-Pyridoxal Phosphate,
pubmed-meshheading:10931579-Risk Assessment,
pubmed-meshheading:10931579-Sensitivity and Specificity,
pubmed-meshheading:10931579-Vomiting
|
pubmed:year |
2000
|
pubmed:articleTitle |
Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).
|
pubmed:affiliation |
Presbyterian University Hospital, Department of Radiology, Pittsburgh, PA 15213, USA.
|
pubmed:publicationType |
Journal Article,
Clinical Trial,
Controlled Clinical Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study,
Clinical Trial, Phase III
|