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Cerebyx Labels Changed
JAMA. 1999;281:786.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The labels on Cerebyx (fosphenytoin sodium injection; Parke Davis) vial and carton are being revised in response to the inadvertent administration of massive overdoses of Cerebyx associated with serious adverse events, including death, that have resulted from some health care workers' mistaken interpretation of the current vial label (both 2-mL and 10-mL vials). Some health care workers withdrawing Cerebyx from the vial have misinterpreted the label to mean that the amount of phenytoin equivalents per milliliter actually represents the total amount of phenytoin equivalents in the vial. The revised labeling is designed to further reinforce understanding of the total amount of phenytoin equivalents (PE) in each Cerebyx vial.
The new 2-mL vial label will read as follows: "Cerebyx (Fosphenytoin Sodium Injection), 100 mg PE in 2 mL, (PE = phenytoin sodium equivalents), 2 mL vial." The new 10-mL vial label will read as follows: "Cerebyx (Fosphenytoin Sodium Injection), 500 mg . . . [Full Text of this Article]
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