Statements in which the resource exists as a subject.
PredicateObject
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: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