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| Gadovist® |   |
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Gadovist® is an extracellular, neutral macrocyclic (gadolinium (Gd) complex) MRI contrast agents for central nervous system indications, particularly suited for studies in which high doses are required or advantageous.
Gadovist® (also Gadograf) was available in two concentrations, currently only Gadovist® 1.0 is marketed.
The product was approved in Switzerland in 1999 and in Germany in 2000. Gadovist® 1.0 is in USA currently in the drug development and approval process, particularly for magnetic resonance angiography. WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
See also Paramagnetic Contrast Agents and Gadobutrol.
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Drug Information and Specification |
| NAME OF COMPOUND |
Gadobutrol, Gd-BT-DO3A
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| DEVELOPER |
Bayer Schering Pharma AG
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| CENTRAL MOIETY |
Gd2+ |
| CONTRAST EFFECT |
T1, Predominantly positive enhancement |
| RELAXIVITY |
r1=3.6, B0=1.0 T |
| PHARMACOKINETIC |
Intravascular, extracellular, renal excretion |
| OSMOLALITY |
557 and 1603 mosm/kgH2O |
| CONCENTRATION |
1 mol/L |
| DOSAGE |
0.1mmol/kg |
| PREPARATION |
Finished product |
| INDICATION |
Central nervous system / whole body |
| DEVELOPMENT STAGE |
For sale / submit for approval |
| DISTRIBUTOR |
See below |
| PRESENTATION |
Vials of 15, 30 mL |
| DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE NOT A SUBSTITUTE FOR THE ACCOMPANYING
PACKAGE INSERT! |
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Further Reading: |
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