Indocyanine Green And Water

1 INDICATIONS AND USAGE Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system ( 1.1 ) • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system ( 1.2 ) • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system ( 1.3 ) 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system 1.2 Visual assessment of the major extrahepatic bile duct For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system. 1.3 Viewing intra-operative blood flow in the cerebral area For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system

2 DOSAGE AND ADMINISTRATION For visual assessment of blood vessels, blood flow and related tissue perfusion ( 2.1 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 0.1 mg/kg (0.04 mL/kg) – 0.3 mg/kg (0.12 mL/kg). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline immediately before IR imaging. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. For visual assessment of the major extrahepatic bile ducts ( 2.2 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 3.0 mg (1.2 mL). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline at least 30 minutes prior to IR imaging. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. For viewing intra-operative blood flow in the cerebral area ( 2.3 ) Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of Indocyanine Green for Injection USP is 0.1 mg/kg (0.04 mL/kg) – 0.3 mg/kg (0.12 mL/kg). Immediately follow each ICG intravenous injection with a tight bolus injection of approximately 10 - 12 mL of normal saline immediately before IR imaging Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. 2.1 Visual assessment of blood vessels, blood flow and related tissue perfusion Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated immediately before IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus injection. Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline. 2.2 Visual assessment of the major extrahepatic bile duct Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The dosage for one administration should be 3.0 mg (1.2 mL) per patient. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated at least 30 minutes prior to IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with 3.0 mg (1.2 mL) of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus. At least 30 minutes prior to IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline. 2.3 Viewing intra-operative blood flow in the cerebral area Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient. ICG should be administrated immediately before IR imaging. Item Note Indocyanine Green for Injection, USP 25 mg vials of ICG powder Sterile Water for Injection (for dissolving ICG) 10 mL vial of sterile water Syringe (for injecting sterile water into the ICG vial) Use the syringe whose minimum volume is 10 mL Syringes (for each administration) Considering the administration volume, select the appropriate size Sterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administration Syringes (for each saline flush) Use the syringe whose minimum volume is 12 mL Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus. Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline.

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.