NDC 73624-424 Indocyanine Green

Indocyanine Green And Water

NDC Product Code 73624-424

NDC 73624-424-02

Package Description: 6 PACKAGE in 1 CARTON > 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)

NDC Product Information

Indocyanine Green with NDC 73624-424 is a a human prescription drug product labeled by Olympus America, Inc.. The generic name of Indocyanine Green is indocyanine green and water. The product's dosage form is kit and is administered via form.

Labeler Name: Olympus America, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM IODIDE (UNII: F5WR8N145C)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Olympus America, Inc.
Labeler Code: 73624
FDA Application Number: ANDA040811 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Indocyanine Green Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Indocyanine Green for Injection USP is indicated:

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

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 NoteIndocyanine Green for Injection, USP25 mg vials of ICG powderSterile Water for Injection (for dissolving ICG)10 mL vial of sterile waterSyringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mLSyringes (for each administration)Considering the administration volume, select the appropriate sizeSterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administrationSyringes (for each saline flush)Use the syringe whose minimum volume is 12 mLPrepare 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 NoteIndocyanine Green for Injection, USP25 mg vials of ICG powderSterile Water for Injection (for dissolving ICG)10 mL vial of sterile waterSyringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mLSyringes (for each administration)Considering the administration volume, select the appropriate sizeSterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administrationSyringes (for each saline flush)Use the syringe whose minimum volume is 12 mLPrepare 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 NoteIndocyanine Green for Injection, USP25 mg vials of ICG powderSterile Water for Injection (for dissolving ICG)10 mL vial of sterile waterSyringe (for injecting sterile water into the ICG vial)Use the syringe whose minimum volume is 10 mLSyringes (for each administration)Considering the administration volume, select the appropriate sizeSterile normal saline (for each saline flush) Approximately 10 – 12 mL following each ICG administrationSyringes (for each saline flush)Use the syringe whose minimum volume is 12 mLPrepare 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.

5.1 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.

8.1 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.

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.

13.1 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].

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