Clariscan | GE Healthcare

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^{1, 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 decades^{1, 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.