Two anaphylactic deaths have been reported following IC-GREENT administration during cardiac catheterization. One of these was in a patient with a history of sensitivity to penicillin and sulfa drugs.

The Aqueous Solvent provided for this proiduct, pH 5.5 to 6.5, which is especially prepared Sterile Water for Injection, should be used to dissolve IC-GREENT because there have been reports of incompatibility with some commercially available Water for Injection.

General: IC-GREENT Powder and Solution: IC-GREENT is unstable in aqueous solution and must be used within 10 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 dilution curves.

IC-GREENT (sterile indocyanine green) powder may cling to the vial or lump together because it is freeze-dried in the vials. This is not due to the presence of water the moisture content is carefully controlled.

Heparin preparations containing sodium bisulfate reduce the absorption peak of IC-GREENT in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis.

The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be significantly greater in women than in men, although there was no significant difference in the calculated value for clearance.

Radioactive iodine uptake studies should not be performed for at least a week following the use of IC-GREENT.

Pregnancy Category C:   Animal Reproduction studies have not been conducted with IC-GREENT. It is also not known whether IC-GREENT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IC-GREENT should be given to a pregnant woman only if clearly indicated.

Nursing Mothers:   It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IC-GREENT is administered to a nursing woman.

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