Indocyanine Green
(Indocyanine Green And Water)Indocyanine Green Prescribing Information
Indocyanine Green for Injection USP is indicated:
2.1 Visual assessment of blood vessels, blood flow and related tissue perfusionUnder 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.
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.
2.2 Visual assessment of the major extrahepatic bile ductUnder 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.
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.
2.3 Viewing intra-operative blood flow in the cerebral areaUnder 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.
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.
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide.
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.
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.
• Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization. ()5.1 AnaphylaxisDeaths from anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.
• Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. ()5.2 Drug InstabilityIndocyanine 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 dilution curves. If a precipitate is present, discard the solution.
• Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP. ()5.3 Drug/Laboratory Test InteractionsRadioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP.