Prepare SPY AGENT GREEN under sterile conditions prior to surgery.Imaging Instructions for Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mappingįluorescent lymphatic vessels and lymph nodes should begin to be visible within 1 minute after injection. The recommended single dose of SPY AGENT GREEN is 5 mg of a 1.25 mg/mL solution (four 1 mL injections administered interstitially into the cervix, at the three o’ clock and the nine o’clock positions with a superficial (1 mm to 3 mm) and a deep (1 cm to 2 cm) injection at each position). Recommended Dose and Administration for Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Tumors
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SPY AGENT GREEN may be used with the PINPOINT® Fluorescence Imaging System or with a FDA cleared or approved imaging device that is specifically intended for fluorescence imaging with Spy Agent Green.įluorescence is visible in the biliary tree within 45 minutes after injection. Imaging Instructions for Visualization of Extrahepatic Biliary Ducts Additional doses may be administered to obtain imaging sequences during the procedure. The recommended single dose of SPY AGENT GREEN for adults and pediatric patients aged 12 to 17 years is 2.5 mg of a 2.5 mg/mL solution administered intravenously as a single dose at least 45 minutes prior to surgery. Recommended Dose and Administration for Visualization of Extrahepatic Biliary Ducts 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 intended for fluorescence imaging with Spy Agent Green.Ī fluorescence response should be visible in blood vessels within 5 to 15 seconds after injection. Imaging Instructions for Visualization of Vessels, Blood Flow and Tissue Perfusion Immediately switch the access on the stopcock and inject the prepared flush. Inject the prepared SPY AGENT GREEN into the line as a tight bolus.
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Prior to the imaging procedure, draw up the desired dosage of SPY AGENT GREEN solution into appropriate syringes and prepare a 10 mL syringe of 0.9% Sodium Chloride, USP.Īdminister via a central or peripheral venous line using a three-way stopcock attached to an injection port on the infusion line. Do not exceed the maximum total dose of 2 mg/kg. Adjust the amount and type of flush to avoid volume and/or sodium overload.Īdditional doses may be administered to obtain imaging sequences during the procedure. Lower doses may be administered in younger patients and in those with lower body weight. The recommended dose for a single image sequence is 1.25 mg to 5 mg SPY AGENT GREEN of a 2.5 mg/mL solution. Immediately flush with a 10 mL bolus of 0.9% Sodium Chloride, USP. The recommended dose of SPY AGENT GREEN for a single image sequence is 1.25 mg to 5 mg of a 2.5 mg/mL solution.įor visualization of perfusion in extremities through the skin, the recommended dose is 3.75 mg to 10 mg of a 2.5 mg/mL solution. Recommended Dose and Administration for Visualization of Vessels, Blood Flow and Tissue Perfusion It has a pH of 5-7 and an osmotic pressure ratio to physiological saline of about 0.01 when 1 vial of Spy Agent Green is dissolved in 5 mL water for injection (0.5% aqueous solution).
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Its melting point is 230☌ (decomposition). Spy Agent Green is unstable in aqueous solution but is stable in the solutions containing protein or in the dry form.
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Spy Agent Green is a dark, green-blue, odorless, lump, soluble in water or methanol and practically insoluble in acetone. Its empirical formula is C 43H 47N 2NaO 6S 2 and molecular weight is 774.96. Spy Agent Green is 2- indolin-2-ylidene]-1, 3, 5-heptatrienyl]-1, 1- (dimethyl-3-(4-sulfobutyl)-1 H-benzindolium hydroxide, inner salt, sodium salt. For Determining Cardiac Output, Hepatic Function and Liver Blood Flow