1. Tweedle MF et al. Considerations in the Selection of a New Gadolinium-Based Contrast Agent. Supplement to Applied Radiology. May 2014. 
  2. Weinreb JC. New Guidelines Use of Gadolinium Contrast Agents. Presented for the Society of Computed Body Tomography and Magnetic Resonance, June 2006. 
  3. Clariscan Summary of Product Characteristics (UK), April 2018.
  4. Marshall G. Radiography 2008; 14: 128-34.
  5. Gricar J et al. Radiol Manage 2007; SEP/OCT: 34-42.
  6. Dhaliwal H et al. Int J Life Cycle Assess 2014; 19: 1965-73.
  7. GE Healthcare Data on File_Production.
  8. GE Healthcare Data on File_Quality.
  9. GE Healthcare Data on File_Inspection.
  10. GE Healthcare Data on File_Investment.

JB00144UK  | November 2020

  • Expanding our portfolio, to offer you a macrocyclic agent expertly manufactured by GE Healthcare

    Stability has become a priority in GBCA choice, shifting attention towards macrocyclic agents1, 2.

    Clariscan is a macrocyclic, ionic GBCA:

    • Cage-like structure encloses and tightly binds the Gd3+ ion1
    • Highly stable1
    • Biologically inert1
    • Rapid biodistribution and elimination3

    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

    GBCA: gadolinium based contrast agents
    MRI: magnetic resonance imaging
    MR: magnetic resonance
    CNS: central nervous system

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

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

    From API production to final delivery, every stage of manufacturing is managed entirely by GE Healthcare.

    Highlights:

    • Clariscan is produced in compliance with cGMP within predefined specifications set in accordance with ICH guidelines7.
    • 20% of employees work in quality control/ quality assurance, to ensure consistently high standards of production8.
    • All of our production sites are cGMP accredited with an excellent track record and no enforcement actions9.

    API: active pharmaceutical ingredient
    cGMP: current good manufacturing practice
    ICH: The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

  • Investing in infrastructure, so you can trust in reliable delivery when you schedule your procedures

    GE Healthcare has invested over $240 million to expand our manufacturing capacity from 2013 to 201810:

    • Both primary API production and secondary filling and finishing capacity increased by more than 50%
    • Additional investments are in progress to take this capacity up by a further 30-40% by 2023

    GE Healthcare have a network of multiple suppliers for a secure supply of pharmaceutical grade ingredients.

    Global delivery supported by a direct logistics network, as well as over 25 local distribution centres. 

  • Adding possibilities

    Advancing at a remarkable rate, MRI has revolutionized your means of diagnosing an array of conditions. From neurology to oncology to cardiology, MRI has had a huge impact in just a few decades1, 2.

    Such progress has been made possible through collaboration – both between disciplines and also with industry3.

    GE Healthcare is proud to be part of the continual evolution of MRI.

    1973: Lauterbur first demonstrates use of NMR images

    1982: We deliver the first clinically viable whole-body MRI scanner

    1993: We launch the first non-ionic CM for MRI

    2003: We introduce the first MRI motion correction technique

    2009: Our researcher, Dr J.Schenck, receives the ISMRM’s highest honour

    2016: We innovate a <10 min="" 4d="" flow="" cardiac="" mr="" exam="">

    Technical and scientific advances, and the resultant benefit to patients are set to continue at an ever expanding and truly remarkable pace4.

    MRI: magnetic resonance imaging
    CM: contrast media
    ISMRM: International Society for Magnetic Resonance in Medicine
    MR: magnetic resonance
    NMR: nuclear magnetic resonance

    Reference:
    1. G Lohrke J et al. Adv Ther 2016; 33(1): 1-28.
    2. Runge VM. Invest Radiol 2015; 48(12): 869-77.
    3. Wood ML et al. Invest Radiol 2015; 50(9): 645-56.
    4. Edelman RR. Radiology 2014; 273(2 Suppl): S181-200.

Prescribing Information

JB01514IN