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Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ .
Adverse events should also be reported to GE HealthCare at
gpv.drugsafety@gehealthcare.com
Features
Effective enhancement
High relaxivity, improving tissue visualisation in a low injection volume²⁻⁶
Macrocyclic structure
Macrocyclic chelate tightly binds
Gd³⁺ ion, providing high molecular stability¹
Convenient packaging options
A broad range tailored to
your procedural needs for
efficient patient care
Expertly manufactured
Reliably delivered with the quality assurance of GE HealthCare
About Gadobutrol
Gadobutrol is a high relaxivity macrocyclic GBCA expanding your choice of agents from GE HealthCare.1,2
Over 80% of GBCA use in Europe is accounted for by gadobutrol and gadoteric acid – we now manufacture and supply both.7
Efficacy
The only GBCA molecule with a concentration of 1.0 M
Gadobutrol is formulated at double the concentration of Gd3+ ions compared to other GBCAs, reducing the injection volume by half and producing a more focused bolus.2 Combined with a high r1 relaxivity, gadobutrol enhances detection, delineation, and characterisation in MRI.2,3,8-11
Image quality
Highly effective in both steady state and dynamic imaging2-6,12
The high relaxivity of Gadobutrol is an advantage when enhancing steady state imaging 3-6,12
Meanwhile, the narrower bolus of gadobutrol is designed to optimise visualisation during dynamic imaging, potentially offering advantages in certain clinical scenarios.2
Usage
Potential to improve diagnostic confidence across a broad range of indications11,13,14
Gadobutrol is indicated for diagnostic contrast enhancement in adult, adolescent, and paediatric populations(including term neonates) for:14
- MRI of the CNS including the brain, spine and surrounding tissue
- Whole body MRI, including liver or kidneys
- MR angiography
Gadobutrol should be used when diagnostic information is essential and not available with unenhanced MRI.
Gadobutrol is well tolerated across diverse patient populations.15,16
Hypersensitivity reactions: As with other intravenous contrast agents, Gadobutrol can be associated with anaphylactoid/hypersensitivity or other idiosyncratic reactions, characterized by cardiovascular, respiratory or cutaneous manifestations, and ranging to severe reactions including shock. In general, patients with cardiovascular disease are more susceptible to serious or even fatal outcomes of severe hypersensitivity reactions.
Packaging
Meeting procedural needs, with packaging that prioritises your workplace safety and efficiency
Gadobutrol offers a range of packaging:
- Glass vials: 7.5 and 15mL
- Clear plastic prefilled syringes: 10, and 15mL
- +PLUSPAK polymer bottles: 30ml
Our unique +PLUSPAK packaging reduces hazard and downtime:
- No more broken bottles, glass or ring-pull injuries 17
It can also reduce costs and environmental impact:
Less storage space, lower disposal costs, reduced environmental impact17-19
Commitment
Gadobutrol is produced in Norway to the same exacting standards as our other contrast agents
Gadobutrol is manufactured in compliance with cGMP regulations and within predefined specifications set in accordance with ICH guidelines.
GE HealthCare continues to invest significantly in expanding our manufacturing capacity to ensure quality supply and distribution so that you can schedule procedures with confidence.20
References
1. Port M et al. Biometals 2008; 21(4): 469-908.
2. Scott LJ. Clin Drug Investig 2018; 38(8): 773-84.
3. Szomolanyi P et al. Invest Radiol 2019; 54(9): 559-64.
4. Rohrer M et al. Invest Radiol 2005; 40(11): 715-24.
5. Shen Y et al. Invest Radiol 2015; 50(5): 330-8.
6. Noebauer-Huhmann IM et al. Invest Radiol 2010; 45(9): 554-8.
7. GE HealthCare Data on File_GBCA_Use.
8. Kramer JH et al. Invest Radiol 2013; 48(3): 121-8.
9. Durmus T et al. Invest Radiol 2012; 47(3): 183-8.
10. Hoelter P et al. Neuroradiology 2017; 59(12): 1233-9.
11. Gutierrez JE et al. Magn Reson Insights 2015; 8: 1-10.
12. Miller K et al. Imaging Med 2011; 3(1): 93–105.
13. Katakami N et al. Invest Radiol 2011; 46(7): 411-8.
14. Gadobutrol Summary of Product Characteristics.
15. Glutig K et al. Pediatr Radiol 2016; 46: 1317-23.
16. Prince MR et al. Eur Radiol. 2017; 27(1): 286-95.
17. Marshall G. Radiography 2008; 14: 128-34.
18. Gricar J et al. Radiol Manage 2007; SEP/OCT: 34-42.
19. Dhaliwal H et al. Int J Life Cycle Assess 2014; 19: 1965-73.
20. GE HealthCare Data on File, Investment November 2023.
cGMP: current good manufacturing practice
CNS: central nervous system
GBCA: gadolinium-based contrast agent
ICH: International Council for Harmonisation
MR: magnetic resonance
MRI: MR imaging
JB04003UK February 2025