INDOCYANINE GREEN FOR

1 Indicator-Dilution Studies In the performance of dye dilution curves, a known amount of dye is 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 systemic 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 Do not use product if mixture (solution) shows haziness, particulate matter, discolouration, or leakage.

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

While sterile water for injection may be used to rinse the syringe, isotonic saline should be used to flush the residual dye from the cardiac catheter into the circulation so as to avoid hemolysis. With the exception of the rinsing of the dye injection syringe, saline should be used in all other parts of the catheterization procedure.

Calibrating Dye Curves:

To quantitate the dilution curves, standard dilutions of Indocyanine Green for Injection, USP in whole blood are made as follows. It is strongly recommended that the same dye that was used for the injections be used in the preparation of these standard dilutions.

The most concentrated dye solution is made by accurately diluting 1 mL of the 5 mg/mL dye with 7 mL of distilled water. This concentration is then successively halved by diluting 4 mL of the previous concentration with 4 mL of distilled water.

5 mg/mL dye is added to 3 mL of distilled water to make the most concentrated “standard” solution. This concentration is then successively halved by diluting 2 mL of the previous concentration with 2 mL of distilled water. 0 mg/liter, approximately (actual concentration depends on the exact volume of dye added).

This concentration is, of course, successively halved in the succeeding aliquots of the subject's blood. 2 mL of saline containing no dye has been added, are then passed through the det ecting instrument and a calibration curve is constructed from the deflections recorded.

1 Adverse Reaction Overview Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides. , epinephrine, antihistamines, and corticosteroids.

1 Anaphylaxis Deaths from anaphylaxis have been reported following Indocyanine Green for Injection, USP administration during cardiac catheterization. 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. 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. 1 Pregnant Women 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.

2 Breast-feeding 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. 3 Pediatrics Safety and effectiveness in pediatric patients have been established.

See DOSAGE AND ADMINISTRATION (Section 3) for specific dosing information in pediatric patients. 4 Geriatrics No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Indocyanine Green for Injection, USP is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non -medicinal ingredient, or component of the container. 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.

For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING (Section 5).