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 'Gadobutrol' 
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GadobutrolInfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.
 
Short name: Gd-DO3A-butriol, generic name: Gadobutrol
A paramagnetic contrast agent with 0.5 and 1.0 molar concentration.

See Contrast Agents and Gadovist®.
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Further Reading:
  News & More:
GE HealthCare introduces new MRI agent Pixxoscan
Friday, 28 April 2023   by www.medicaldevice-network.com    
Bayer receives European approval for Gadovist (gadobutrol) for use in pediatric patients less than 2 years of age
Tuesday, 14 July 2015   by pipelinereview.com    
FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
Monday, 5 January 2015   by www.prnewswire.com    
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Gadovist®InfoSheet: - Contrast Agents - 
Intro, Overview, 
Characteristics, 
Types of, 
etc.MRI Resource Directory:
 - Contrast Agents -
 
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.
Drug Information and Specification
NAME OF COMPOUND
Gadobutrol, Gd-BT-DO3A
CENTRAL MOIETY
Gd2+
CONTRAST EFFECT
T1, Predominantly positive enhancement
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!
Distribution Information
TERRITORY
TRADE NAME
DEVELOPMENT
STAGE
DISTRIBUTOR
USA
Gadovist®
Submit for approval
Japan
Gadovist®
EU
Gadovist®
for sale
Australia
Gadovist®
for sale
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Further Reading:
  Basics:
Important Drug Warning for Gadolinium-Based Contrast Agents
Wednesday, 12 September 2007   by www.ismrm.org    
Gadograf, Gadovist
Friday, 13 April 2007   by www.ema.europa.eu    
  News & More:
EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Friday, 21 July 2017   by www.ema.europa.eu    
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
Tuesday, 19 December 2017   by www.fda.gov    
FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
Monday, 5 January 2015   by www.prnewswire.com    
New data presented at RSNA on use of Bayer's Gadavist® (gadobutrol) injection in children less than 2 years of age
Wednesday, 3 December 2014   by www.prnewswire.com    
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