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Litteratur
1)
MultiHance Produktresumé
2)
Gadobenate dimeglumine (Gd-BOPTA). An overview
3)
Safety, tolerance, biodistribution and MR imaging enhancement of the liver with gadobenate dimeglumine: results of clinical pharmacologic and pilot imaging studies in nonpatient and patient volunteers.
4)
Hepatobiliary MR imaging with gadolinium-based contrast agents.
5)
Matched within-patient cohort study of transient arterial phase respiratory motion-related artifact in MR imaging of the liver: gadoxetate disodium versus gadobenate dimeglumine.
6)
Transient arterial phase respiratory motion-related artifact in MR imaging of the liver: an analysis of four different gadolinium-based contrast agents.
7)
Effect of Gadoxetate Disodium on Arterial Phase Respiratory Waveforms Using a Quantitative Fast Fourier Transformation-Based Analysis.
8)
Gadobenate dimeglumine-enhanced liver MR imaging: value of dynamic and delayed imaging for the characterization and detection of focal liver lesions.
9)
Hepatocellular carcinoma in patients with cirrhosis: qualitative comparison of gadobenate dimeglumine-enhanced MR imaging and multiphasic 64-section CT.
10)
Accurate differentiation of focal nodular hyperplasia from hepatic adenoma at gadobenate dimeglumine-enhanced MR imaging: prospective study.
11)
Solid hypervascular liver lesions: accurate identification of true benign lesions on enhanced dynamic and hepatobiliary phase magnetic resonance imaging after gadobenate dimeglumine administration.
12)
Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths.
13)
Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents.
14)
Influence of human serum albumin on longitudinal and transverse relaxation rates (r1 and r2) of magnetic resonance contrast agents.
15)
T1 relaxivities of gadolinium-based magnetic resonance contrast agents in human whole blood at 1.5, 3, and 7 T.
16)
A serial dilution study of gadolinium-based MR imaging contrast agents.
17)
Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years.
18)
Safety characteristics of gadobenate dimeglumine: clinical experience from intra- and interindividual comparison studies with gadopentetate dimeglumine.
19)
Safety of gadobenate dimeglumine (MultiHance): Summary of findings from clinical studies and postmarketing surveillance.
20)
Bracco Data on File
21)
Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance) in children.
22)
Renal safety of intravenous gadolinium-enhanced magnetic resonance imaging in patients awaiting liver transplantation.
23)
Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report.
24)
A Prospective Cohort Study of Nephrogenic Systemic Fibrosis in Patients With Stage 3-5 Chronic Kidney Disease Undergoing MRI With Injected Gadobenate Dimeglumine or Gadoteridol.
25)
Evaluation of the incidence of nephrogenic systemic fibrosis in patients with moderate renal insufficiency administered gadobenate dimeglumine for MRI.
26)
Retrospective assessment of prevalence of nephrogenic systemic fibrosis (NSF) after implementation of a new guideline for the use of gadobenate dimeglumine as a sole contrast agent for magnetic resonance examination in renally impaired patients.
27)
Nephrogenic systemic fibrosis: change in incidence following a switch in gadolinium agents and adoption of a gadolinium policy--report from two U.S. universities.
28)
Decreased incidence of NSF in patients on dialysis after changing gadolinium contrast-enhanced MRI protocols.
29)
Incidence of nephrogenic systemic fibrosis after adoption of restrictive gadolinium-based contrast agent guidelines.
30)
Prospective cohort study of NSF in patients with stage 3-5 CKD undergoing MRI with gadobenate or gadoteridol.
31)
Gadobenate dimeglumine administration and nephrogenic systemic fibrosis: Is there a real risk in patients with impaired renal function?
32)
Incidence of nephrogenic systemic fibrosis using gadobenate dimeglumine in 1423 patients with renal insufficiency compared with gadodiamide.
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ANSVARSFRASKRIVELSE
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Gadolinium-tilbageholdelse
Efter administration of gadobensyre, kan gadolinium tilbageholdes i hjernen og andet kropsvæv (knogler, lever, nyrer og hud) og kan medføre dosisafhængige stigninger i T1-vægtet signalintensitet i hjernen, især i nucleus dentatus, globus pallidus og thalamus. De kliniske følgevirkninger er ukendte. De mulige diagnostiske fordele ved at bruge MultiHance til patienter med behov for gentagne scanninger bør opvejes mod risikoen for aflejring af gadolinium i hjernen og andet væv.
Nedsat nyrefunktion
Før administration af MultiHance anbefales det, at alle patienter screenes for nyredysfunktion ved at rekvirere laboratorieprøver.
Der er rapporteret nefrogenisk systemisk fibrose (NSF), der sættes i forbindelse med brugen af visse former for gadolinium, indeholdende kontraststoffer hos patienter med akut eller kronisk svært nedsat nyrefunktion (GFR < 30 ml/ min/1,73m2).
Patienter, der får foretaget levertransplantation, er i særlig risiko, da incidensen af akut nyresvigt er høj i denne gruppe. Da der er risiko for, at NSF kan optræde med MultiHance, bør det derfor undgås hos patienter med svært nedsat nyrefunktion og hos patienter i den perioperative levertransplantationsperiode, medmindre de diagnostiske oplysninger er essentielle og ikke tilgængelige med ikke-kontrastforstærket MRI.
Hæmodialyse kort tid efter administration af MultiHance kan være nyttigt til fjernelse af MultiHance fra kroppen. Der er ikke evidens der støtter initiering af hæmodialyse til forhindring eller behandling af NSF hos patienter, der ikke allerede oplever hæmodialyse.
Ældre personer
Da udskillelse af gadobenatdimeglumin fra nyrerne kan være nedsat hos ældre, er det særlig vigtigt at screene patienter på 65 år og derover for nyredysfunktion.