Indocyanine Green for Injection USP is supplied in a kit (NDC 73624-424-02) containing 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. STORAGE: Store at 20° t...
Animal reproduction studies have not been conducted with Indocyanine Green for Injection USP. It is also not known whether Indocyanine Green for Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green for Injection USP should be given to a pregnant woman only if clearly indicated.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Indocyanine Green for Injection USP is administered to a nursing woman.
The safety and effectiveness of indocyanine green for visual assessment of blood vessels, blood flow and related tissue perfusion, for visual assessment of the major extrahepatic bile duct and for intra-operative blood flow in the cerebral area using this IR imaging application has not been evaluated in pediatric patients.
No overall differences in safety or effectiveness have been observed between elderly and adult patients.
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. Based on body surface area, these doses are 2.4 to 13-fold the maximum recommended human (MRHD) dose of 2 mg/kg for indicator-dilution studies, 10 to 52-fold the MRHD of 0.5 mg/kg for hepatic-function studies, and 7 to 39-fold the MRHD of 0.67 mg/kg for ophthalmic angiography studies.
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.
Indocyanine Green for Injection USP permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. 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. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green for Injection USP a helpful index of hepatic function.
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, and therefore, excessive dye extravasation does not take place in the highly fenestrated choroidal vasculature. It is, therefore, useful in both absorption and fluorescence infrared angiography of the choroidal vasculature when using appropriate filters and film in a fundus camera.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be significantly greater in women than in men, although there was no significant difference in the calculated value for clearance.
No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Indocyanine Green for Injection USP is supplied in a kit (NDC 73624-424-02) containing 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.
STORAGE:Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature].
Manufactured by:
Patheon Italia S.p.A.
20900 Monza (MB), ITALY
Distributed by:
OLYMPUS AMERICA INC.
3500 Corporate Parkway
P.O. Box 610
Center Valley, PA, 18034-0610
Sterile Water for Injection,
USP is manufactured by:
Fresenius Kabi USA, LLC
Grand Island, NY 14072 USA
or
Hospira, Inc.
Rocky Mount, NC 27804 USA
50652
06/2020
NDC 73624-424-02
Indocyanine Green
for Injection, USP
For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile
Distributed by:
OLYMPUS AMERICA INC.
Back Panel
NDC 73624-424-02
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.
Contents:Six Indocyanine Green for Injection, USP
vials (25 mg each)
Six Sterile Water for Injection, USP Vials
(10 mL each)
Indocyanine Green
for Injection, USP
For Intravenous Administration 25 mg/Vial Kit Rx Only - Sterile
Right Panel
Indocyanine Green
for Injection, USP
Distributed by:
OLYMPUS AMERICA INC.
3500 Corporate Parkway, P.O. Box 610,
Center Valley, PA 1834-0610, U.S.A.
Manufactured by:
Patheon Italia S.p.A.
20900 Monza (Milano) ITALY
Sterile Water Manufactured by:
Hospira, Inc.
Rocky Mount, NC 27804
or
Fresenius Kabi USA, LLC
Grand Island, NY 14072
4/2020
NDC 70100-424-01
Indocyanine Green
for Injection, USP
25 mg/Vial
Single-Patient-Use
After reconstitution, use within 6 hours.
Rx only Sterile
Distributed by: Diagnostic Green LLC
50428
04/2022
Lot No.
Exp.:
10 mL Single-dose
Sterile Water
for Injection, USP
FOR DRUG DILUENT USE
LOT ##-###-AA
EXP DMMMYYYY
Rx only NDC 0409-4887-17
Contains no antimicrobial or other added
substance.
Sterile, nonpyrogenic. Do not give
intravenously unless rendered nearly isotonic.
Distributed by RL-7603
Hospira, Inc., Lake Forest, IL 60045 USA
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59368-398 | 59368-398-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM IODIDE | F5WR8N145C | IACT |
| INDOCYANINE GREEN | IX6J1063HV | ACTIB |
| WATER | 059QF0KO0R | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 36e97df8-59f6-deb2-e063-6394a90a6cc5 | 36e9751a-ca4e-f374-e063-6394a90a4192 | 2023-01-01 | 36e97df8-59f6-deb2-e063-6394a90a6cc5 36e9751a-ca4e-f374-e063-6394a90a4192 |
Adverse event summaries are temporarily unavailable. Other product information remains available.