Indocyanine Green And Water

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

What Is Indocyanine Green And Water Used For?

1 INDICATIONS AND USAGE Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated:

Dosage and Administration

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...

Side Effects (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.

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 )

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 )

Pregnancy and Breastfeeding

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.

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.

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].