Overview

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 agents.

Macrocyclic, ionic GBCA:

  • Cage-like structure encloses and tightly binds the Gd3+ ion
  • Highly stable
  • Biologically inert
  • Rapid biodistribution and elimination

Adding Inclusivity

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

Clariscan is indicated for diagnostic contrast enhancement in:

  • Whole body MRI including the major organs, pelvis, breast and muscoskeletal system
  • MRI of the CNS including the brain, spine and surrounding tissue
  • MR angiography including non-coronary arteries

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

References:
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, November 2017.

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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 guidelines.
  • 20% of employees work in quality control/ quality assurance, to ensure consistently high standards of production.
  • All of our production sites are GMP accredited with an excellent track record and no enforcement actions.

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

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

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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

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


References:
1. GE Healthcare Data on File_Investment.

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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 decades.

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

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

1973: Lauterbur first demonstrates use of NMR images
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 pace.

References:
1. 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.

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Prescribing Information


Bijwerkingen rapporteren

Beroepsbeoefenaren in de gezondheidszorg worden verzocht alle vermoedelijke bijwerkingen te melden via: Nederlands Bijwerkingen Centrum Lareb, website: www.lareb.nl. Bijwerkingen kunnen ook direct worden gerapporteerd aan GE Healthcare B.V.


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