sábado, 5 de septiembre de 2015

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

On March 10, 2015, the FDA issued a statement warning health care professionals not to use chemotherapy drug Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).
As an update, FDA is providing information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection (See Tables 1 and 2).  Treanda (bendamustine hydrochloride) is used to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. 
For more information, please visit: Treanda.

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