Label Changes for:

INVANZ (ertapenem) Injection, 1 gm

July 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

July 2013

ADVERSE REACTIONS

Post-Marketing Experience
  • depressed level of consciousness

 

December 2009

 

ADVERSE REACTIONS

Postmarketing Experience
  • includes altered mental status (including aggression, delirium), dyskinesia, myoclonus, and tremor

 

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