{"adverse_reactions":["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."],"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 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. 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."],"contraindications":["4 CONTRAINDICATIONS Indocyanine Green for Injection, USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. Indocyanine Green for Injection, USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. ( 4 )"],"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. Chemical Structure"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Perfusion Assessment ( 2.1 ) Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. ICG must be used within 6 hours after reconstitution. A 3 mL (7.5 mg) dose, followed by a 10 mL bolus of saline, is recommended. Multiple doses can be administered as required. Extra-Hepatic Biliary Anatomy ( 2.2 ) Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. ICG must be used within 6 hours after reconstitution. A 0.02 mL/kg dose that is scaled to the patient’s weight, followed by a 10 mL bolus of saline, is recommended. This provides 0.05 mg/kg of ICG. 2.1 Perfusion Assessment Preparation of ICG for Administration Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. Indocyanine Green for Injection, USP must be used within 6 hours after reconstitution. If a precipitate is present, discard the solution. Dosage A 3 mL (7.5 mg) dose followed by a 10 mL bolus of saline is recommended. Multiple doses can be administered as required, up to the maximum recommended dose. Maximum recommended dose The total dose of dye injected should be kept below 2 mg/kg. Timing of ICG Administration ICG fluorescence is quickly visible within blood vessels, tissue and organs, and it does not last very long (refer to Table 1 below). Table 1: ICG fluorescence visibility after intravenous injection Blood Vessels Organs (Kidney, Liver, Adrenal Gland, Small Bowel) See within: 5-30 seconds 1-2 minutes Visibility lasts: 20-30 seconds 20-120 minutes For fluorescence imaging of PERFUSION in blood vessels, administration of the ICG should be performed at the time fluorescence imaging is requested by the physician. Multiple imaging sequences may be performed as necessary [up to the maximum dose (2 mg/kg of patient body weight)], so it is recommended to withdraw the desired dosage of ICG solution for each planned imaging sequence into separate syringes ahead of time. Method of Administration ICG administration is to be performed via a central or peripheral venous line. Inject the prepared dose of ICG solution into the central or peripheral line as a tight bolus and immediately followed by a bolus of 10-12 mL of normal saline for injection. 2.2 Extra-Hepatic Biliary Anatomy Preparation of ICG for Administration Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. Indocyanine Green for Injection, USP must be used within 6 hours after reconstitution. If a precipitate is present, discard the solution. Dosage A 0.02 mL/kg dose that is scaled to the patient’s weight is recommended. This provides 0.05 mg/kg of ICG. Maximum recommended dose The total dose of dye injected should be kept below 2 mg/kg. Timing of ICG Administration Following intravenous injection, ICG is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). ICG is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. For optimal fluorescence imaging of Extra-Hepatic Biliary Anatomy, ICG should be administered at least 45 minutes prior to the time fluorescence imaging is desired by the physician. If this preoperative administration is not performed, however, ICG can be administered once the patient is in the OR, as adequate fluorescence imaging is possible in as little as 15 minutes after IV injection. Method of Administration ICG administration is to be performed via a central or peripheral venous line. Inject the prepared weight-scaled dose of ICG solution into the central or peripheral line as a tight bolus and immediately followed by a bolus of 10-12 mL of normal saline for injection."],"dosage_and_administration_table":["
Table 1: ICG fluorescence visibility after intravenous injection
Blood VesselsOrgans (Kidney, Liver, Adrenal Gland, Small Bowel)
See within:5-30 seconds1-2 minutes
Visibility lasts:20-30 seconds20-120 minutes
"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Indocyanine Green for Injection, USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection, USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. ( 3 )"],"drug_interactions":["7 DRUG INTERACTIONS Preparations containing sodium bisulfite, including some heparin products reduce the absorption peak of Indocyanine Green for Injection, USP in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis. Products containing sodium bisulfite reduce the absorption peak of Indocyanine Green for Injection, USP in blood. ( 7 )"],"effective_time":"20201113","geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING ICG for Injection Set is a kit (NDC 70599-424-02) containing one Indocyanine Green for Injection, USP kit (NDC 70100-424-02) and these Instructions For Use with the KARL STORZ ICG Imaging System. The Indocyanine Green for Injection, USP kit (NDC 70100-424-02) contains 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. ICG for Injection Set Distributed by: KARL STORZ Endoscopy-America, Inc. El Segundo, CA 90245 USA 50441"],"id":"84872330-522f-4e7a-83d4-8906bc1a02da","indications_and_usage":["1 INDICATIONS AND USAGE ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. Indocyanine Green for Injection, USP used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as: ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. ICG for Injection Set used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as: • Visual assessment of vessels, blood flow and related tissue perfusion. ( 1.1 ) • Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. ( 1.2 ) 1.1 Visual assessment of vessels, blood flow and related tissue perfusion 1.2 Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization."],"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 LD 50 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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - KIT CARTON Kit Carton Label Front Panel NDC 70599-424-02 PN: VTG0001 ICG for Injection Set For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile STORZ KARL STORZ-ENDOSKOPE Back Panel NDC 70599-424-02 PN: VTG0001 ICG for Injection Set Contents: Six Indocyanine Green for Injection, USP vials (25 mg each) Six Sterile Water for Injection, USP Vials (10 mL each) Lot Code Area No Print / No Coating STORZ KARL STORZ-ENDOSKOPE For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile 06/2016 Left Panel ICG for Injection Set 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. 25 mg/Vial Kit Right Panel ICG for Injection Set Distributed by: KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Ave. El Segundo, CA 90245 Phone: (800) 421-0837 Fax: (800) 321-1304 E-Mail: communications@karlstorz.com Web: www.karlstorz.com Rx Only 25 mg/Vial Kit Principal Display Panel - Kit Carton Label","PRINCIPAL DISPLAY PANEL - VIAL Vial Label NDC 70100-424-01 Indocyanine Green for Injection, USP 25 mg/Vial For Intravenous Administration After reconstitution, use within 6 hours. Rx only Sterile Distributed by Diagnostic Green LLC 50428 Lot. No. Exp. Principal Display Panel - Vial Label","PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL Sterile Water Label 10 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE Rx only NDC 0409-4887-17 Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Do not give intravenously unless rendered nearly isotonic. Hospira, Inc. RL-4428 Lake Forest, IL 60045 USA Principal Display Panel - Sterile Water Vial Label"],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients have been established."],"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":"06c018a4-293e-42b5-b77a-bb121501cb16","spl_product_data_elements":["ICG Indocyanine Green and Water Indocyanine Green Indocyanine Green INDOCYANINE GREEN INDOCYANINE GREEN ACID FORM SODIUM IODIDE Sterile Water Water WATER WATER"],"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 Safety and effectiveness in pediatric patients have been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"version":"3","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."]}