The Food and Drug Administration (FDA) has approved the Gadavist® (gadobutrol; Bayer Healthcare) Imaging Bulk Package.

The Imaging Bulk Package will be supplied as 604.72mg of gadobutrol per mL in 30mL and 65mL multidose containers. It is intended to be used across multiple patients and work shifts for up to 24 hours after the first puncture. According to the Company, the bulk package could potentially result in more complete usage of the contrast and fewer vials wasted and also adheres to the Joint Commission requirements related to multi-patient dosing.

Additionally, the FDA has cleared the MEDRAD® Imaging Bulk Package Transfer Spike, which is indicated for the transfer of Gadavist® contrast media as supplied in the Imaging Bulk Package presentation.

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Gadavist, a gadolinium-based contrast agent, is indicated for use in MRI of the CNS in adults and children (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity; MRI of the breast to assess the presence and extent of malignant breast disease; MRI to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adults with known or suspected coronary artery disease; and magnetic resonance angiography (MRA) in adults and children (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.

For more information visit bayer.us.

References

  1. FDA approves Gadavist® (gadobutrol) Imaging Bulk Package. https://www.businesswire.com/news/home/20200813005263/en/FDA-Approves-Gadavist%C2%AE-gadobutrol-Imaging-Bulk-Package. Accessed August 13, 2020. 
  2. Gadavist [package insert]. Whippany, NJ: Bayer Healthcare; 2020.