Indocyanine Green 2.5 mg/mL · Injection: 25 mg per 10 mL (2.5 mg per mL) of indocyanine green as a deep emerald-green ready-to-use solution in a single-dose ampule.
Diagnostic Dye, Injections & Implants
ZYOGREEN 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.
Contraindications
ZYOGREEN is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis.
2.5 mg, 25 mg single-dose ampules, 10 mL single-dose ampules
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.
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.
Warnings & Precautions
- 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 .
- Interference with Thyroid Radioactive Iodine Uptake Studies: Because ZYOGREEN contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration .
Common Side Effects
The most common adverse reactions reported are anaphylaxis and urticaria.
Pregnancy: There are no adequate and well-controlled studies of ZYOGREEN in pregnant women.
Lactation: Seventeen cases of indocyanine green use in lactating women have been reported in the scientific literature with no adverse events observed in the breastfed infant. However, there are no data on the presence of indocyanine green in human milk or the effects on milk production.
Use in Pediatric Patients for Visualization of Vessels, Blood Flow and Tissue Perfusion The safety and effectiveness of ZYOGREEN 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.