Recommended Dose And Administration For Visualization Of Extrahepatic Biliary Ducts Dosing And Administration 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 indocyanine 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. 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 isģ.75 mg to 10 mg of a 2.5 mg/mL solution. SLIDESHOW Digestive Disorders: Common Misconceptions See SlideshowĭOSAGE AND ADMINISTRATION Recommended Dose And Administration For Visualization Of Vessels, Blood Flow And Tissue Perfusion Dosing fluorescence imaging of lymph nodes and delineation of lymphatic vessels in the cervix and uterus during lymphatic mapping in patients with solid tumors for which this procedure is a component of intraoperative management.SPY AGENT™ GREEN is indicated in women for: Visualization Of Lymph Nodes And Lymphatic Vessels During Lymphatic Mapping For Cervical And Uterine Tumors fluorescence imaging of extrahepatic biliary ducts.SPY AGENT™ GREEN is indicated in adults and pediatric patients aged 12 to 17 years for: Visualization Of Extrahepatic Biliary Ducts fluorescence imaging of micro-and macro-vasculature, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, and plastic, micro-and reconstructive surgeries, including general minimally invasive surgical procedures.SPY AGENT™ GREEN is indicated in adults and pediatric patients one month of age and older for: INDICATIONS Visualization Of Vessels, Blood Flow And Tissue Perfusion SPY AGENT GREEN has a pH of 5.5 to 7.5 when reconstituted with Sterile Water for Injection, USP. Indocyanine green has a peak spectral absorption at 800 nm. Molecular Formula: C 43H 47N 2NaO 6S 2 Molecular Mass: 774.96 g/mol, with the following structural formula: The chemical name for Indocyanine Green is 1 HBenzindolium, 2- indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4sulfobutyl)-, hydroxide, inner salt, sodium salt. Each vial contains a sterile, lyophilized green powder containing 25 mg of indocyanine green with not more than 5% sodium iodide. SPY AGENT GREEN (indocyanine green for injection, USP) is a water soluble, optical imaging agent which is reconstituted with Sterile Water for Injection, USP, for intravenous or interstitial use. You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Spy Agent Green. Tell the doctor if you have any side effect that bothers you or that does not go away. The most common side effects of Spy Agent Green include: Get medical help right away, if you have any of the symptoms listed above. swelling of your face, lips, tongue, or throat,.Spy Agent Green may cause serious side effects including: What are the possible side effects of Spy Agent Green? It is not known if Spy Agent Green is safe and effective in children younger than 4 weeks of age. Spy Agent Green belongs to a class of drugs called. Spy Agent Green may be used alone or with other medications. Spy Agent Green is a prescription medicine used as an optical imaging agent. What is Spy Agent Green and how is it used?