Description
GE Healthcare
A macrocyclic molecule expertly manufactured by GE Healthcare
Expanding GE Healthcare’s 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.
