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U.S. Department of Health and Human Services

Safety

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Optimark (Gadoversetamide) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

CONTRAINDICATIONS

Hypersensitivity Reactions
  • Severe hypersensitivity reactions including anaphylaxis have been observed with administration of gadolinium products including Optimark…