Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate. Diagnostic efficacy was demonstrated in numerous studies and various indications, such as diseases of the CNS, peripheral and supra-aortic vessels, kidneys, liver, and breast.
Keyphrases
- magnetic resonance imaging
- contrast enhanced
- end stage renal disease
- ejection fraction
- newly diagnosed
- body weight
- chronic kidney disease
- computed tomography
- magnetic resonance
- peritoneal dialysis
- young adults
- prognostic factors
- emergency department
- blood brain barrier
- electronic health record
- left ventricular
- patient reported outcomes
- middle aged
- case control