Indocyanine green

• 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 aged 1 month and older. • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years 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

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. These optical properties of indocyanine green are utilized in fluorescence imaging of the micro- and macro-vasculature, blood flow and tissue perfusion, the extrahepatic biliary ducts, and for lymphatic mapping of lymph nodes and lymphatic vessels.

• Visualization of vessels, blood flow and tissue perfusion (2.5 mg/mL solution) o 1.25 mg to 5 mg by intravenous injection is recommended for a surgical procedure in adults and pediatric patients aged 1 month and older. o 3.75 mg to 10 mg by intravenous injection is recommended for visualization of perfusion in extremities through the skin for plastic, micro- and reconstructive surgeries in adults. o Additional doses may be administered. Do not exceed a total dose of 2 mg/kg. • Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older (2.5 mg/mL solution) o 2.5 mg by intravenous injection at least 45 minutes prior to surgery. o Additional doses may be administered. Do not exceed a total dose of 2 mg/kg.

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

Hypersensitivity reactions: Hypersensitivity reactions including anaphylaxis and urticaria have occurred. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor patients.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions. The following adverse reactions have been identified during post-approval use of IC-GREEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Anaphylaxis, urticaria The most common adverse reactions reported are anaphylaxis and urticaria.

Interference with Thyroid Radioactive Iodine Uptake Studies Because IC-GREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of IC-GREEN. Interference with Thyroid Radioactive Iodine Uptake Studies: Do not perform radioactive iodine uptake studies for at least one week following the use of IC-GREEN.

Store at 20°C to 25°C (68°F to 77°F).