GE gets FDA nod to package Clariscan in polymer bottle

By staff writers

September 15, 2020 -- GE Healthcare has received U.S. Food and Drug Administration (FDA) clearance to use its +PlusPak pharmacy bulk package polymer bottle for the company's Clariscan macrocyclic gadolinium-based MRI contrast agent.

Featuring a pharmaceutical-grade polypropylene composition, the polymer bottle reduces the risk of breakage and injury from broken glass, and its cap helps avoid cuts from metal crimps, according to the vendor.

The packaging also enables Clariscan to be transferred to sterile syringes up to 24 hours after initial puncture, facilitating weight-based dosing and use of the agent in multiple patients and across work shifts, GE said. The bottle is also recyclable.

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