ICG- indocyanine green and water kit

ICG by

Drug Labeling and Warnings

ICG by is a Prescription medication manufactured, distributed, or labeled by KARL STORZ Endoscopy-America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    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:

    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.

  • 2 DOSAGE AND ADMINISTRATION

    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.

  • 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 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.

  • 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

    Safety and effectiveness in pediatric patients have been established.

    8.5 Geriatric Use

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

  • 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.

    Chemical Structure
  • 12 CLINICAL PHARMACOLOGY

    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.

  • 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

    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

  • PRINCIPAL DISPLAY PANEL - KIT CARTON

    Principal Display Panel - Kit Carton Label

    Kit Carton Label

    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

  • PRINCIPAL DISPLAY PANEL - VIAL

    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

    Lot. No.
    Exp.

  • PRINCIPAL DISPLAY PANEL - STERILE WATER VIAL

    Principal Display Panel - Sterile Water Vial Label

    Sterile Water Label

    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

  • INGREDIENTS AND APPEARANCE
    ICG 
    indocyanine green and water kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70599-424
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70599-424-026 in 1 CARTON06/01/2016
    11 in 1 PACKAGE; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL 1 
    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
    ANDAANDA04081106/01/2016
    Labeler - KARL STORZ Endoscopy-America, Inc. (075293423)
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