İHALE DÜNYASI
İHALE DÜNYASI
Indocyanine Green for Injection, USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Sterile Water for Injection, USP used to dissolve the indocyanine green. Indocyanine Green for Injection, USP is to be administered intravenously. Indocyanine green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1 H -Benz[ e ]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2 H -benz[ e ] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, inner salt, sodium salt. Indocyanine Green for Injection, USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection, USP contains 25 mg of indocyanine green as a sterile lyophilized powder. Chemical Structure
ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. Indocyanine Green for Injection, USP used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as: ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. ICG for Injection Set used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as: * Visual assessment of vessels, blood flow and related tissue perfusion. ( 1.1 ) * Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. ( 1.2 ) 1.1 Visual assessment of vessels, blood flow and related tissue perfusion 1.2 Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Visual assessment of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Perfusion Assessment ( 2.1 ) Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. ICG must be used within 6 hours after reconstitution. A 3 mL (7.5 mg) dose, followed by a 10 mL bolus of saline, is recommended. Multiple doses can be administered as required. Extra-Hepatic Biliary Anatomy ( 2.2 ) Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. ICG must be used within 6 hours after reconstitution. A 0.02 mL/kg dose that is scaled to the patient's weight, followed by a 10 mL bolus of saline, is recommended. This provides 0.05 mg/kg of ICG. 2.1 Perfusion Assessment Preparation of ICG for Administration Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. Indocyanine Green for Injection, USP must be used within 6 hours after reconstitution. If a precipitate is present, discard the solution. Dosage A 3 mL (7.5 mg) dose followed by a 10 mL bolus of saline is recommended. Multiple doses can be administered as required, up to the maximum recommended dose. Maximum recommended dose The total dose of dye injected should be kept below 2 mg/kg. Timing of ICG Administration ICG fluorescence is quickly visible within blood vessels, tissue and organs, and it does not last very long (refer to Table 1 below). Table 1: ICG fluorescence visibility after intravenous injection Blood Vessels Organs (Kidney, Liver, Adrenal Gland, Small Bowel) See within: 5-30 seconds 1-2 minutes Visibility lasts: 20-30 seconds 20-120 minutes For fluorescence imaging of PERFUSION in blood vessels, administration of the ICG should be performed at the time fluorescence imaging is requested by the physician. Multiple imaging sequences may be performed as necessary [up to the maximum dose (2 mg/kg of patient body weight)], so it is recommended to withdraw the desired dosage of ICG solution for each planned imaging sequence into separate syringes ahead of time. Method of Administration ICG administration is to be performed via a central or peripheral venous line. Inject the prepared dose of ICG solution into the central or peripheral line as a tight bolus and immediately followed by a bolus of 10-12 mL of normal saline for injection. 2.2 Extra-Hepatic Biliary Anatomy Preparation of ICG for Administration Under sterile conditions, reconstitute one (1) 25 mg vial of Indocyanine Green for Injection, USP using one (1) 10 mL Sterile Water for Injection, USP vial located in the ICG for Injection Set. Shake the ICG vial gently to dissolve. After reconstitution, a 25 mg vial of ICG contains 2.5 mg of dye per mL of solution, so a 1.0 mL injection contains a 2.5 mg dose of ICG. Indocyanine Green for Injection, USP must be used within 6 hours after reconstitution. If a precipitate is present, discard the solution. Dosage A 0.02 mL/kg dose that is scaled to the patient's weight is recommended. This provides 0.05 mg/kg of ICG. Maximum recommended dose The total dose of dye injected should be kept below 2 mg/kg. Timing of ICG Administration Following intravenous injection, ICG is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). ICG is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. For optimal fluorescence imaging of Extra-Hepatic Biliary Anatomy, ICG should be administered at least 45 minutes prior to the time fluorescence imaging is desired by the physician. If this preoperative administration is not performed, however, ICG can be administered once the patient is in the OR, as adequate fluorescence imaging is possible in as little as 15 minutes after IV injection. Method of Administration ICG administration is to be performed via a central or peripheral venous line. Inject the prepared weight-scaled dose of ICG solution into the central or peripheral line as a tight bolus and immediately followed by a bolus of 10-12 mL of normal saline for injection.
Indocyanine Green for Injection, USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. Indocyanine Green for Injection, USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. ( 4 )
Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids. Most common adverse reactions are anaphylactic or urticarial reactions. These have been reported in patients with and without a history of allergy to iodides. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
* Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. ( 5.1 ) * Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours. ( 5.2 ) * Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection, USP. ( 5.3 ) 5.1 Anaphylaxis Deaths from anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. 5.2 Drug Instability Indocyanine Green for Injection, USP is unstable in aqueous solution and must be used within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as well as in the performance of the procedures. If a precipitate is present, discard the solution. 5.3 Drug/Laboratory Test Interactions Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection, USP.
Preparations containing sodium bisulfite, including some heparin products reduce the absorption peak of Indocyanine Green for Injection, USP in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis. Products containing sodium bisulfite reduce the absorption peak of Indocyanine Green for Injection, USP in blood. ( 7 )