Indocyanine Green [ICG] Angiography Dye Injection

NDC: 70100-424-02

Indocyanine Green (ICG) 25 mg Powder for Injection, 25 mg Vial with Diluent — HUB Pharmaceuticals

Active ingredient	Indocyanine green 25 mg per vial (sterile lyophilized powder)
Dosage form	Lyophilized powder for reconstitution (kit with sterile water diluent)
Route	Intravenous (also interstitial for lymphatic mapping)
Size	25 mg vial with sterile water for injection diluent
Manufacturer	HUB Pharmaceuticals
NDC	70100-424-02

Indications and Usage

Fluorescence imaging agent used for determination of cardiac output, hepatic function and blood flow, and for ophthalmic and other angiography, including intraoperative visualization of vessels, biliary ducts, and lymphatic mapping.

Dosage and Administration

Reconstitute with sterile water for injection per intended use (commonly 10 mL, yielding 2.5 mg/mL). Typical adult intravenous doses are 1.25-5 mg for vascular and blood-flow studies and about 2.5 mg for biliary imaging; 5 mg per site interstitially for lymphatic mapping. Total dose should generally not exceed 2 mg/kg.

Warnings and Precautions

• Risk of anaphylactic and anaphylactoid reactions and urticaria; monitor patients after administration
• Contains sodium iodide; interferes with radioactive iodine uptake thyroid studies for about one week
• Use caution in patients with iodide sensitivity
• Use reconstituted solution promptly and within the labeled hold time

Contraindications

Known hypersensitivity to indocyanine green or iodides.

Adverse Reactions

Anaphylaxis and urticaria are the most notable reactions; other hypersensitivity-type reactions may occur.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); use reconstituted solution within 6 hours.

How Supplied

Carton kit containing lyophilized indocyanine green 25 mg vial(s) with sterile water for injection diluent.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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