Use of indocyanine green for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. Imaging Instructions for Visualization of Vessels, Blood Flow and Tissue Perfusion 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. 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. Do not exceed the maximum total dose of 2 mg/kg.Īdministration 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. 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. Pediatric patients: 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.
#SPY AGENT GREEN KIT COST FULL#
( 2.4)įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Visualization of Vessels, Blood Flow and Tissue Perfusion 1.2 Visualization of Extrahepatic Biliary Ducts 1.3 Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Tumors 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose and Administration for Visualization of Vessels, Blood Flow and Tissue Perfusion 2.2 Recommended Dose and Administration for Visualization of Extrahepatic Biliary Ducts 2.3 Recommended Dose and Administration for Visualization of Lymph Nodes and Lymphatic Vessels During Lymphatic Mapping for Cervical and Uterine Tumors 2.4 Reconstitution Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 5.2 Interference with Radioactive Iodine Uptake Studies 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.Ģ.1 Recommended Dose and Administration for Visualization of Vessels, Blood Flow and Tissue Perfusionĭosing Adults: 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. See Full Prescribing Information for instructions on reconstitution of the lyophilized powder, and preparation and administration of injections. Inject at the 3 and 9 o’clock positions of the cervix with a superficial (1 to 3 mm) and deep (1 to 3 cm) injection at each position.
#SPY AGENT GREEN KIT COST SKIN#
Visualization of Vessels, Blood Flow and Tissue Perfusion (2.5 mg/mL solution):
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