Clariscan™

Clariscan™ (gadoteric acid) is a macrocyclic gadolinium-based contrast agent, expertly manufactured by GE Healthcare, used to enhance visualization in MRI procedures across a range of indications
Contact us
Full Prescribing Information
At a glance

Macrocyclic structure

Macrocyclic, ionic chelate provides high kinetic and themodynamic stability1

Expertly manufactured

Quality manufacture and delivery, expertly managed by GE for greatest control

Established tolerability

Over 17 million patient administrations, with low level of adverse events2,3

Convenient packaging options

Vials, prefilled syringes and +PLUSPAK bottles in a range of volumes
ABOUT CLARISCAN

Clariscan is a macrocyclic, general-purpose GBCA. Used to enhance over 17 million MRI procedures globally since launch, Clariscan is manufactured in-house by GE Healthcare in a range of packaging options and has a well-established tolerability profile3

STRUCTURE

Gadoteric acid: the only macrocylic, ionic molecule

Stability refers to how tightly the gadolinium ion is bound to the chelating molecule and how likely it is to dissociate. Gadoteric acid is the only macrocyclic, ionic molecule across all gadoliunium-based contrast agents. In vitro data suggest that combining a macrocyclic structure for high kinetic stability, with ionicity for thermodynamic stability, may help to reduce the potential risk of gadolinium dissociation.1
USAGE

A broad range of indications and well-established tolerability profile3

Clariscan is indicated for diagnostic contrast enhancement in3:
  • MRI of the CNS including the brain, spine and surrounding tissue
  • Whole body MRI including the major organs, pelvis, breast and muscoskeletal system (not recommended for children below 6 months)
  • MR angiography including lesions or stenoses of the non-coronary arteries (adults only)
Clariscan should be used when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).

Clariscan has been approved in more than 80 countries with over 17 million doses shipped globally. There are no signals to suggest that the safety profile of Clariscan is different to that established for the reference product, Dotarem®.2
PACKAGING

Meeting procedural needs, with packaging that prioritises your workplace safety and efficiency

Clariscan offers a range of packaging:
  • Glass vials: 5, 10, 15, and 20 mL
  • Clear plastic prefilled syringes: 10, 15, and 20 mL
  • +PLUSPAK polymer bottles: 50 and 100 mL
Our unique +PLUSPAK packaging reduces hazard and downtime:
  • No more broken bottles, glass or ring-pull injuries4
It also reduces costs and environmental impact:
  • Less storage space, lower disposal costs, reduced environmental impact4-6
COMMITMENT

Keeping production of Clariscan in-house, so you can be assured standards are maintained from start to finish

GE Healthcare has invested over $385M since 2013 in expansion of our manufacturing capacity to meet growing demand for our contrast agents. All our manufacturing sites are cGMP-accredited and we work closely with regulatory agencies globally to ensure quality supply.7
REFERENCES
  1. 1. Port M et al. Biometals. 2008;21(4):469-490.
  2. 2. GE Healthcare Data on File, Safety Profile Clariscan August 2022
  3. 3. Clariscan Summary of Product Characteristics, UK, GE Healthcare, April 2022.
  4. 4. Marshall G. Radiography 2008; 14: 128-34.
  5. 5. Gricar J et al. Radiol Manage 2007; SEP/OCT: 34-42.
  6. 6. Dhaliwal H et al. Int J Life Cycle Assess 2014; 19: 1965-73.
  7. 7. GE Healthcare Data on File, Investment 2021.
Dotarem is a trademark of Guerbet LLC.

JB02112UK 11-2022

 

Prescribing Information

Please click here for Clariscan prescribing information

Adverse events should be reported
Reporting forms and information can be found at: yellowcard.mhra.gov.uk
Adverse events should also be reported to GE Healthcare at:
gpv.drugsafety@ge.com

JB02112UK