ICG Pulsion (Indocyanine Green for Injection USP and Aqueous Solvent Kit)

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Indocyanine Green for Injection USP, is supplied in a kit containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials.

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. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously. Indications and

Usage: For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography.

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.

Warnings: Anaphylactic deaths have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.

Precautions:

General: Indocyanine Green Powder and Solution: Indocyanine Green 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. Indocyanine Green powder may cling to the vial or lump together because it is freeze-dried in the vials.

Drug Interactions: Heparin preparations containing sodium bisulfite reduce the absorption peak of Indocyanine Green in blood and, therefore, should not be used as an anticoagulant for the collection of samples for analysis.

Drug/Laboratory Test Interactions: Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of feritility

Pregnancy: Teratogenic Efects: Pregnancy Category C: Animal Reproduction studies have not been conducted with Indocyanine Green. It is also not known whether Indocyanine Green can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Indocyanine Green should be given to a pregnant woman only if clearly indicated.

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 is administered to a nursing woman.

Pediatric Use:  Safety and effectiveness in pediatric patients have been established.

Adverse Reactions:  Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. If such reactions occur, treatment with the appropriate agents (e.g., epinephrine, antihistamines, and corticosteroids) should be administered.

Overdosage:  There are no data available describing the signs, symptoms, or laboratory findings accompanying overdosage. The LD50 after I.V.  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.

Dosage and Administration:  Indicator-Dilution Studies:Indocyanine Green permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation. In the performance of dye dilution curves, a known amount of dye is usually injected as a single bolus as rapidly as possible via a cardiac catheter into selected sites in the vascular system. A recording instrument (oximeter or densitometer) is attached to a  needle or catheter for sampling of the dye-blood mixture from a systematic arterial sampling site.  Under sterile conditions, the Indocyanine Green for Injection USP powder should be dissolved with Sterile Water for Injection, USP, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution. The amount of solvent to be used can be calculated from the dosage form which follows. It is recommended that the syringe  used for injection of the dye be rinsed with this diluent. Saline is used in all other parts of the catheterization procedure.  This matter of rinsing the dye syringe with distilled water may not be critical, since it is known that an amount of sodium chloride sufficient to make an isotonic solution may be added to dye that has first been dissolved in distilled water. This procedure has been used for constant-rate injection techniques without precipitation of the dye.

The usual doses of Indocyanine Green which have been used for dilution curves are as follows:

  Adults—5 mg
  Children—2.5 mg
  Infants—1.25 mg

These doses of the dye are usually injected in a 1-mL volume. An average of five dilution curves is required in the performance of a diagnostic cardiac catheterization. The total dose of dye injected should be kept below 2 mg/kg.

How Supplied:  Indocyanine Green for Injection USP, is supplied in a kit, (NDC 025431-424-02) containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials.

NDC 025431-424-01 Indocyanine Green for Injection 25-mg fill in 30-mL vial.
NDC 63323-185-10 Sterile Water for Injection 10-mL fill in 10-mL vial.

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