Finished product reference

Indocyanine Green

Injection, Powder, for Solution · Parenteral · 25 mg

List code
15281
Pharmacologic class
Diagnostic Dye

What it is and how it works

Mechanism of Action When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near infrared light for indocyanine green to absorb, resulting in excitation of the indocyanine green, and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor.

Mechanism class: Dyes

Indications

is an optical imaging agent indicated for: Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer Ophthalmic angiography in adults and pediatric patients Visualization of Vessels, Blood Flow and Tissue Perfusion ZYOGREEN is indicated for fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures in adults and pediatric patients.

Dosage and administration (summary)

Visualization of vessels, blood flow and tissue perfusion Pediatric patients less than 1 month of age: 0.15 mg/kg Adults and pediatric patients 1 month of age and older: 1.25 mg to 5 mg by intravenous injection Extremity perfusion visualization through the skin Pediatric patients less than 1 month of age: 0.15 mg/kg Pediatric patients 1 month of age and older: 1.25 mg to 5 mg Adults: 3.75 mg to 10 mg by intravenous injection Visualization of extrahepatic biliary ducts Pediatric patients from birth to less than 1 year of age: 0.1 mg/kg (not to exceed 2.5 mg) 12 to 24 hours prior to surgery Adults and pediatric patients 6 years of age and older: 2.5 mg by intravenous injection at least 45 minu…

Contraindications

is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis . Hypersensitivity to indocyanine green

Warnings and precautions

Hypersensitivity reactions: Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients. Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis, urticaria, and deaths due to anaphylaxis have been reported following intravenous administration of indocyanine green, the active ingredient in ZYOGREEN . ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green .

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies of ZYOGREEN in pregnant women. Available data from a very small number of scientific literature studies with indocyanine green use in pregnant women over several decades have not reported any drug associated risks for major birth defects, miscarriage, or adverse maternal or fe…

Storage and supply

How Supplied ZYOGREEN (Indocyanine Green Injection), is a deep emerald-green ready-to-use solution in amber glass ampules supplied as follows: NDC ZYOGREEN ® (Indocyanine Green Injection) (2.5 mg per mL) Package Factor 25021-841-10 25 mg per 10 mL Single-Dose Ampules 5 ampules per carton Storage and Handling Store at 20°C to 25°C (68°F to 77°F).

Source: Indocyanine Green (Zyogreen) — US FDA prescribing information, 2026-07-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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