ICG

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:

Indocyanine Green for Injection, USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide.

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.

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.

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.

There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD₅₀ after intravenous administration ranges between 60 and 80 mg/kg in mice, 50 and 70 mg/kg in rats and 50 and 80 mg/kg in rabbits.

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)-2H-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.

Following intravenous injection, Indocyanine Green for Injection, USP is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). Indocyanine Green for Injection, USP undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green for Injection, USP is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile.

The peak absorption and emission of Indocyanine Green for Injection, USP lie in a region (800 to 850 nm) where transmission of energy by the pigment epithelium is more efficient than in the region of visible light energy. Indocyanine Green for Injection, USP also has the property of being nearly 98% bound to blood protein.

ICG for Injection Set is a kit (NDC 70599-424-02) containing one Indocyanine Green for Injection, USP kit (NDC 70100-424-02) and these Instructions For Use with the KARL STORZ ICG Imaging System.

The Indocyanine Green for Injection, USP kit (NDC 70100-424-02) contains six 25 mg Indocyanine Green for Injection, USP vials and six 10 mL Sterile Water for Injection, USP plastic vials:

NDC 70100-424-01 Indocyanine Green for Injection, USP vial. 25 mg fill in 25 mL vial.

NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection, USP, 10 mL fill in 10 mL plastic vials.

ICG for Injection Set

Distributed by:

KARL STORZ Endoscopy-America, Inc.
El Segundo, CA 90245 USA

50441

Front Panel

NDC 70599-424-02                    PN: VTG0001

ICG for Injection Set

For Intravenous Administration     25 mg/Vial Kit     Rx Only - Sterile

STORZ
KARL STORZ-ENDOSKOPE

Back Panel

NDC 70599-424-02                    PN: VTG0001

ICG for Injection Set

Contents:
Six Indocyanine Green for Injection, USP vials (25 mg each)
Six Sterile Water for Injection, USP Vials (10 mL each)

Lot Code Area
No Print / No Coating

STORZ
KARL STORZ-ENDOSKOPE

For Intravenous Administration     25 mg/Vial Kit     Rx Only - Sterile     06/2016

Left Panel

ICG for Injection Set

DIRECTIONS FOR USE ENCLOSED

CAUTION: To ensure accurate readings,
Indocyanine Green, USP dissolved in Sterile Water
for Injection, USP must be used within 6 hours.

STORAGE: Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

USAGE: See package insert for dosage information.

25 mg/Vial Kit

Right Panel

ICG for Injection Set

Distributed by:
KARL STORZ
Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo, CA 90245
Phone: (800) 421-0837
Fax: (800) 321-1304
E-Mail: communications@karlstorz.com
Web: www.karlstorz.com

Rx Only

25 mg/Vial Kit

NDC 70100-424-01

Indocyanine Green
for Injection, USP

25 mg/Vial

For Intravenous Administration
After reconstitution, use within 6 hours.

Rx only      Sterile

Distributed by Diagnostic Green LLC

50428

Lot. No.
Exp.

10 mL   Single-dose

Sterile Water
for Injection, USP

FOR DRUG DILUENT USE

Rx only               NDC 0409-4887-17

Contains no antimicrobial or other added
substance. Sterile, nonpyrogenic. Do not give
intravenously unless rendered nearly isotonic.

Hospira, Inc.              RL-4428
Lake Forest, IL 60045 USA