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Omniscan (Gadodiamide) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Convulsions have been reported with intravenous use in patients with and without a history of convulsions or brain lesions.
- prior hypersensitivity reaction to Omniscan
WARNINGS AND PRECAUTIONS
- Hypersensitivity Reaction - Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory and/or cutaneous manifestations, resulting in death have occurred…