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ICG for Injection Set
  • Professionals
  • FDA PI

ICG for Injection Set

Generic name: indocyanine green and water
Dosage form: kit
Drug classes:Miscellaneous diagnostic dyes, Ophthalmic diagnostic agents

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

Indications and Usage for ICG for Injection Set

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:

Visual assessment of vessels, blood flow and related tissue perfusion

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.

ICG for Injection Set Dosage and Administration

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.

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