IC-Green Dosage

​2.1 Recommended Dose, Administration and Imaging for Visualization of Vessels, Blood Flow and Tissue Perfusion​

​Dosing

​Adults:

​The recommended dose of IC-GREEN for a single image sequence for visualization of vessels, blood flow and tissue perfusion in adults is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution.

​For visualization of perfusion in extremities through the skin in adults, the recommended dose is 3.75 mg to 10 mg administered intravenously as 1.5 mL to 4 mL of a 2.5 mg/mL solution.

​Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride Injection.

​Pediatric patients aged 1 month and older:

​The recommended dose of IC-GREEN for a single image sequence for visualization of vessels, blood flow and tissue perfusion in pediatric patients aged 1 month and older is 1.25 mg to 5 mg administered intravenously as 0.5 mL to 2 mL of a 2.5 mg/mL solution. Lower doses may be administered in younger patients and in those with lower body weight. Adjust the amount and type of flush to avoid volume and/or sodium overload.

​In both adults and pediatric patients aged 1 month and older, additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.

​Administration

​Prior to the imaging procedure, draw up the desired dose of IC-GREEN solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride Injection.

​Administer via a central or peripheral venous line using a three-way stopcock attached to an injection port on the infusion line. Inject the prepared IC-GREEN into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush.

​Imaging Instructions

​IC-GREEN may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of vessels, blood flow and tissue perfusion.

​A fluorescence response should be visible in blood vessels within 5 seconds to 15 seconds after injection.

​2.2 Recommended Dose, Administration and Imaging for Visualization of Extrahepatic Biliary Ducts​

​Dosing and Administration

​The recommended dose of IC-GREEN for visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older is 2.5 mg administered intravenously as 1 mL of a 2.5 mg/mL solution at least 45 minutes prior to surgery.

​Additional doses may be administered to obtain imaging sequences during the procedure.

​Do not exceed a total dose of 2 mg/kg.

​Imaging Instructions

​IC-GREEN may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of extrahepatic biliary ducts.

Fluorescence is visible in the biliary tree within 45 minutes after injection.

​2.3 Recommended Dose, Administration and Imaging for Lymphatic Mapping of Cervical and Uterine Cancer​

​Dosing and Administration

​The recommended dose of IC-GREEN for lymphatic mapping of cervical and uterine cancer in adults is 5 mg administered interstitially as four 1 mL injections of a 1.25 mg/mL solution into the cervix, at the 3 o’ clock and the 9 o’clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 3 cm) injection at each position.

​Imaging Instructions

​IC-GREEN may be used with an FDA-authorized imaging device that is intended to be used with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of cervical and uterine cancer.

​Fluorescent lymphatic vessels and lymph nodes should begin to be visible within 1 minute after injection.

Recommended Dose and Administration for Ophthalmic Angiography

Dosing and Administration

Doses up to 40 mg IC-GREEN in 2 mL of Sterile Water for Injection depending on the imaging equipment and technique used should be administered intravenously and immediately followed by a 5 mL bolus of 0.9% Sodium Chloride Injection. The antecubital vein can be used for IC-GREEN administration.

Reconstitution Instructions

General

•

Prepare IC-GREEN using aseptic techniques prior to procedure.

•

Inspect the reconstituted solution for particulate matter. The reconstituted solution should be a clear, green solution.

•

Use the prepared solution within 6 hours.

•

Discard any unused product.

​Visualization of Vessels, Blood Flow, Tissue Perfusion and Extrahepatic Biliary Ducts

​Dissolve 25 mg of IC-GREEN with 10 mL Sterile Water for Injection to form a concentration of 2.5 mg/mL indocyanine green.

​Lymphatic Mapping of Cervical and Uterine Cancer

​Dissolve 25 mg of IC-GREEN with 20 mL Sterile Water for Injection to form a concentration of 1.25 mg/mL indocyanine green.

Ophthalmic Angiography

Dissolve doses up to 40 mg of IC-GREEN with 2 mL Sterile Water for Injection.