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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. ( 5.1 ) • Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours. ( 5.2 ) • Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection, USP. ( 5.3 ) 5.1 Anaphylaxis Deaths from anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. 5.2 Drug Instability Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the procedures. If a precipitate is present, discard the solution. 5.3 Drug/Laboratory Test Interactions Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection, USP.
6 ADVERSE REACTIONS Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids. Most common adverse reactions are anaphylactic or urticarial reactions. These have been reported in patients with and without a history of allergy to iodides. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.