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Abraxane-白蛋白紫杉醇-FDA说明书.pdf

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Abraxane-白蛋白紫杉醇-FDA说明书.pdf

上传人:陈潇睡不醒 2021/3/26 文件大小:915 KB

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Abraxane-白蛋白紫杉醇-FDA说明书.pdf

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文档介绍:HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- DOSAGE FORMS AND STRENGTHS -------------------­
These highlights do not include all the information needed to use • For injectable s uspension: lyophilized powder c ontaining 100 mg of
ABRAXANE safely and effectively. See full prescribing paclitaxel in single-use vial f or rec onstitution. (3)
information for ABRAXANE.
------------------------------ CONTRAINDICATIONS ----------------------------­
3
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound • Neutrophil counts of < 1,500 cells/mm . (4)
particles for injectable suspension) (albumin-bound) • Severe hypers ensitivity reaction to ABRAXANE. (4)
Initial . Approv al: 2005
----------------------- WARNINGS AND PRECAUTIONS ---------------------­

• ABRAXANE caus es myelos uppression. Monitor CBC and withhold
WARNING: NEUTROPENIA and/or reduc e the dos e as needed. ()
See full prescribing information for complete boxed warning. • Sens ory neuropathy occurs frequently and may require dos e
reduction or treatment interruption. ()
• Do not administer ABRAXANE therapy to patients with •
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