"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Anaphylactic deaths have been reported following IC-GREEN™ (tricarbocyanine) administration during cardiac catheterization.
General: IC-GREEN™ (tricarbocyanine) Powder and Solution: IC-GREEN™ (tricarbocyanine) 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 dilution curves. IC-GREEN™ (tricarbocyanine) (indocyanine green for injection) powder may cling to the vial or lump together because it is freeze-dried in the vials.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal Reproduction studies have not been conducted with IC-GREEN™ (tricarbocyanine) . It is also not known whether IC-GREEN™ (tricarbocyanine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IC-GREEN™ (tricarbocyanine) 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-GREEN™ (tricarbocyanine) is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have been established.
Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Ic-Green Information
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