Spy Agent Green Dosage

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

Dosing
Adults:
The recommended dose of SPY AGENT 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, USP.

Pediatric patients aged 1 month and older:
The recommended dose of SPY AGENT 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 SPY AGENT GREEN solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride Injection, USP.

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 SPY AGENT GREEN into the line as a tight bolus. Immediately switch the access on the stopcock and inject the prepared flush.

Imaging Instructions
SPY AGENT GREEN may be used with either the SPY® Elite or PINPOINT® Fluorescence Imaging Systems or with a FDA cleared or approved imaging device that is specifically indicated for use 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.

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

Dosing and Administration
The recommended dose of SPY AGENT 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
SPY AGENT GREEN may be used with the PINPOINT® Fluorescence Imaging System or with a FDA cleared or approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of extrahepatic biliary ducts.

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

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

Dosing and Administration
The recommended dose of SPY AGENT 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
SPY AGENT GREEN may be used with the PINPOINT® Fluorescence Imaging System or with a FDA cleared or approved imaging device that is specifically indicated for use 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, Administration and Imaging for Lymphatic Mapping of Breast Cancer

Dosing and Administration
The recommended dose of SPY AGENT GREEN for lymphatic mapping of breast cancer in adults is 0.25 mg per breast administered intradermally as two 0.05 mL injections of a 2.5 mg/mL solution into the peri-areolar area at the 12 o’clock and the 9 o’clock positions for the right breast or at the 12 o’clock and 3 o’clock positions for the left breast.

If lymphatic flow towards the axillary lymph nodes is not visualized, a subsequent peri-tumoral dose of 0.375 mg (three 0.05 mL injections intradermally at the 12 o’clock, 3 o’clock and 9 o’clock positions) is recommended.

Imaging Instructions
SPY AGENT GREEN may be used during open field surgery with the SPY Portable Handheld Imaging (SPY-PHI®) System or with a FDA cleared or approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of breast cancer.

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

Reconstitution Instructions

General

• Prepare SPY AGENT GREEN under sterile conditions prior to surgery.
• 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 and Lymphatic Mapping of Breast Cancer
Dissolve SPY AGENT GREEN with 10 mL Sterile Water for Injection, USP to form a concentration of 2.5 mg indocyanine green/mL.

Lymphatic Mapping of Cervical and Uterine Cancer
Dissolve SPY AGENT GREEN with 20 mL Sterile Water for Injection, USP to form a concentration of 1.25 mg indocyanine green/mL.