Clariscan (gadoteric acid)

  • 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.

    Macrocyclic, ionic GBCA:

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

    Adding Inclusivity

    Providing flexibility for everyday practice, with multiple indications across a breadth of patient types.

    Clariscan is indicated for diagnostic contrast enhancement in3:

    • Whole body MRI including the major organs, pelvis, breast and muscoskeletal system (not recommended for children below 6 months)
    • MRI of the CNS including the brain, spine and surrounding tissue
    • 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

    Reference:
    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.

  • Adding confidence

    Keeping all production in-house, so you can be reassured 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 GMP within predefined specifications set in accordance with ICH guidelines1.
    • 20% of employees work in quality control/ quality assurance, to ensure consistently high standards of production2.
    • All of our production sites are GMP accredited with an excellent track record and no enforcement actions3.

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

    Reference:
    1. GE Healthcare Data on File_Production.
    2. GE Healthcare Data on File_Quality.
    3. GE Healthcare Data on File_Inspection.

  • Adding value

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

    • A robust supply chain
    • Production capacity that is prepared for growth

    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.

    Primary, secondary and finishing capacities have increased by 50% in the last 3 years1.

    Investments in progress to increase production capacity by a further 50% by 2019.

    Reference:
    1. GE Healthcare Data on File_Investment.

  • 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.