INDOCYANINE GREEN- indocyanine green and water kit

Indocyanine Green by

Drug Labeling and Warnings

Indocyanine Green by is a Prescription medication manufactured, distributed, or labeled by Olympus America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Indocyanine Green for Injection USP is indicated:

    1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion

    For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system

    1.2 Visual assessment of the major extrahepatic bile duct

    For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system.

    1.3 Viewing intra-operative blood flow in the cerebral area

    For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Visual assessment of blood vessels, blood flow and related tissue perfusion

    Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.

    The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administrations can be performed, up to 2 mg/kg (0.8 mL/kg) per patient.

    ICG should be administrated immediately before IR imaging.

    Item

    Note

    Indocyanine Green for Injection, USP

    25 mg vials of ICG powder

    Sterile Water for Injection (for dissolving ICG)

    10 mL vial of sterile water

    Syringe (for injecting sterile water into the ICG vial)

    Use the syringe whose minimum volume is 10 mL

    Syringes (for each administration)

    Considering the administration volume, select the appropriate size

    Sterile normal saline (for each saline flush)

    Approximately 10 – 12 mL following each ICG administration

    Syringes (for each saline flush)

    Use the syringe whose minimum volume is 12 mL

    Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus injection.

    Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline.

    2.2 Visual assessment of the major extrahepatic bile duct

    Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.

    The dosage for one administration should be 3.0 mg (1.2 mL) per patient. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient.

    ICG should be administrated at least 30 minutes prior to IR imaging.

    Item

    Note

    Indocyanine Green for Injection, USP

    25 mg vials of ICG powder

    Sterile Water for Injection (for dissolving ICG)

    10 mL vial of sterile water

    Syringe (for injecting sterile water into the ICG vial)

    Use the syringe whose minimum volume is 10 mL

    Syringes (for each administration)

    Considering the administration volume, select the appropriate size

    Sterile normal saline (for each saline flush)

    Approximately 10 – 12 mL following each ICG administration

    Syringes (for each saline flush)

    Use the syringe whose minimum volume is 12 mL

    Prepare the syringes filled with 3.0 mg (1.2 mL) of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus.

    At least 30 minutes prior to IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline.

    2.3 Viewing intra-operative blood flow in the cerebral area

    Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with the 10 mL Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.

    The patient should be weighed and the dosage for one administration should be calculated on the basis of 0.1 mg/kg (0.04 mL/kg) - 0.3 mg/kg (0.12 mL/kg) of body weight. Multiple administration can be performed, up to 2 mg/kg (0.8 mL/kg) per patient.

    ICG should be administrated immediately before IR imaging.

    Item

    Note

    Indocyanine Green for Injection, USP

    25 mg vials of ICG powder

    Sterile Water for Injection (for dissolving ICG)

    10 mL vial of sterile water

    Syringe (for injecting sterile water into the ICG vial)

    Use the syringe whose minimum volume is 10 mL

    Syringes (for each administration)

    Considering the administration volume, select the appropriate size

    Sterile normal saline (for each saline flush)

    Approximately 10 – 12 mL following each ICG administration

    Syringes (for each saline flush)

    Use the syringe whose minimum volume is 12 mL

    Prepare the syringes filled with the weight-scaled dose of ICG solution, and the syringes filled with 10 - 12 mL of normal saline for the tight bolus.

    Immediately before IR imaging, administer the prepared dose of ICG solution intravenously. Immediately follow each ICG injection with a tight bolus injection of approximately 10 - 12 mL of normal saline.

  • 3 DOSAGE FORMS AND STRENGTHS

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

  • 4 CONTRAINDICATIONS

    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.

  • 5 WARNINGS AND PRECAUTIONS

    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 dilution curves. 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.

  • 6 ADVERSE REACTIONS

    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.

  • 7 DRUG INTERACTIONS

    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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    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.

    8.3 Nursing Mothers

    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.

    8.4 Pediatric Use

    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.

    8.5 Geriatric Use

    No overall differences in safety or effectiveness have been observed between elderly and adult patients.

  • 10 OVERDOSAGE

    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.

  • 11 DESCRIPTION

    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.

    Structure
  • 12 CLINICAL PHARMACOLOGY

    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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    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

  • PRINCIPAL DISPLAY PANEL - Carton Label

    Principal Display Panel - Carton Label

    Carton Label

    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

  • PRINCIPAL DISPLAY PANEL - Vial Label

    Principal Display Panel - Vial Label

    Vial Label

    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
    06/2017

  • PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL

    Principal Display Panel - Sterile Water

    Sterile Water Label

    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

  • INGREDIENTS AND APPEARANCE
    INDOCYANINE GREEN 
    indocyanine green and water kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73624-424
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 73624-424-026 in 1 CARTON04/01/2021
    11 in 1 PACKAGE; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL
    Part 21 VIAL, PLASTIC 10 mL
    Part 1 of 2
    INDOCYANINE GREEN 
    indocyanine green injection, powder, lyophilized, for solution
    Product Information
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INDOCYANINE GREEN (UNII: IX6J1063HV) (INDOCYANINE GREEN ACID FORM - UNII:C4V974V932) INDOCYANINE GREEN25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM IODIDE (UNII: F5WR8N145C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04081101/01/2008
    Part 2 of 2
    STERILE WATER 
    water injection
    Product Information
    Item Code (Source)NDC: 0409-4887
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0409-4887-1710 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01880110/27/1982
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04081104/01/2021
    Labeler - Olympus America, Inc. (060321254)

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