{"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY Indocyanine Green for Injection USP permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. Following intravenous injection, Indocyanine Green for Injection USP is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). Indocyanine Green for Injection USP undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green for Injection USP is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green for Injection USP a helpful index of hepatic function. The peak absorption and emission of Indocyanine Green for Injection USP lie in a region (800 to 850 nm) where transmission of energy by the pigment epithelium is more efficient than in the region of visible light energy. Indocyanine Green for Injection USP also has the property of being nearly 98% bound to blood protein, and therefore, excessive dye extravasation does not take place in the highly fenestrated choroidal vasculature. It is, therefore, useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera. 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."],"description":["11 DESCRIPTION Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP used to dissolve the indocyanine green. Indocyanine Green for Injection USP is to be administered intravenously. Indocyanine green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1 H -Benz[ e ]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2 H -benz[ e ] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, inner salt, sodium salt. Indocyanine Green for Injection USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection USP contains 25 mg of indocyanine green as a sterile lyophilized powder. Structure"],"effective_time":"20230101","geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Indocyanine Green for Injection USP is supplied in a kit (NDC 73624-424-02) containing six 25 mg Indocyanine Green for Injection USP vials and six 10 mL Sterile Water for Injection, USP plastic vials: NDC 70100-424-01 Indocyanine Green for Injection USP vial. 25 mg fill in 25 mL vial. NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection, USP, 10 mL fill in 10 mL plastic vials. STORAGE: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]."],"id":"36e97df8-59f6-deb2-e063-6394a90a6cc5","nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility."],"nursing_mothers":["8.3 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 Indocyanine Green for Injection USP is administered to a nursing woman."],"openfda":{},"overdosage":["10 OVERDOSAGE There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after intravenous administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits. Based on body surface area, these doses are 2.4 to 13-fold the maximum recommended human (MRHD) dose of 2 mg/kg for indicator-dilution studies, 10 to 52-fold the MRHD of 0.5 mg/kg for hepatic-function studies, and 7 to 39-fold the MRHD of 0.67 mg/kg for ophthalmic angiography studies."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Carton Label NDC 73624-424-02 Indocyanine Green for Injection, USP For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile Distributed by: OLYMPUS AMERICA INC. Back Panel NDC 73624-424-02 DIRECTIONS FOR USE ENCLOSED CAUTION: To ensure accurate readings, Indocyanine Green, USP dissolved in Sterile Water for Injection, USP must be used within 6 hours. STORAGE: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. USAGE: See package insert for dosage information. Contents: Six Indocyanine Green for Injection, USP vials (25 mg each) Six Sterile Water for Injection, USP Vials (10 mL each) Indocyanine Green for Injection, USP For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile Right Panel Indocyanine Green for Injection, USP Distributed by: OLYMPUS AMERICA INC. 3500 Corporate Parkway, P.O. Box 610, Center Valley, PA 1834-0610, U.S.A. Manufactured by: Patheon Italia S.p.A. 20900 Monza (Milano) ITALY Sterile Water Manufactured by: Hospira, Inc. Rocky Mount, NC 27804 or Fresenius Kabi USA, LLC Grand Island, NY 14072 4/2020 Principal Display Panel - Carton Label","PRINCIPAL DISPLAY PANEL - Vial Label NDC 70100-424-01 Indocyanine Green for Injection, USP 25 mg/Vial Single-Patient-Use After reconstitution, use within 6 hours. Rx only Sterile Distributed by: Diagnostic Green LLC 50428 04/2022 Lot No. Exp.: Principal Display Panel - Vial Label","PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL 10 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE LOT ##-###-AA EXP DMMMYYYY Rx only NDC 0409-4887-17 Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Do not give intravenously unless rendered nearly isotonic. Distributed by RL-7603 Hospira, Inc., Lake Forest, IL 60045 USA Principal Display Panel - Sterile Water"],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of indocyanine green for visual assessment of blood vessels, blood flow and related tissue perfusion, for visual assessment of the major extrahepatic bile duct and for intra-operative blood flow in the cerebral area using this IR imaging application has not been evaluated in pediatric patients."],"pregnancy":["8.1 Pregnancy Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated."],"set_id":"36e9751a-ca4e-f374-e063-6394a90a4192","spl_product_data_elements":["Indocyanine Green Indocyanine Green and Water Indocyanine Green Indocyanine Green SODIUM IODIDE INDOCYANINE GREEN INDOCYANINE GREEN ACID FORM Sterile Water Water WATER WATER"],"spl_unclassified_section":["Manufactured by: Patheon Italia S.p.A. 20900 Monza (MB), ITALY Distributed by: OLYMPUS AMERICA INC. 3500 Corporate Parkway P.O. Box 610 Center Valley, PA, 18034-0610 Sterile Water for Injection, USP is manufactured by: Fresenius Kabi USA, LLC Grand Island, NY 14072 USA or Hospira, Inc. Rocky Mount, NC 27804 USA 50652 06/2020"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated. 8.3 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 Indocyanine Green for Injection USP is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of indocyanine green for visual assessment of blood vessels, blood flow and related tissue perfusion, for visual assessment of the major extrahepatic bile duct and for intra-operative blood flow in the cerebral area using this IR imaging application has not been evaluated in pediatric patients. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients."],"version":"1"}