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Spy Agent Green (indocyanine green)
Australian Prescription Medicine Decision Summary
Published
Product name
Spy Agent Green
Active ingredient
Indocyanine green
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Spy Agent Green (indocyanine green) was approved for the following therapeutic use:
For fluorescence imaging use only.
Spy Agent Green (indocyanine green) is an imaging agent (dye) intended for:
1. Visualisation of vessels, blood flow and tissue perfusion in adults and paediatric patients from one month of age and above.
2. Visualisation of extrahepatic biliary ducts in adults and children from 12 years of age and above.
3. Visualisation of lymph nodes and lymphatic vessels in women with cervical or uterine solid tumours for which lymphatic mapping is a component of intraoperative management.
Visualisation with Spy Agent Green requires an imaging system that has been validated for fluorescence imaging with indocyanine green.
How this medicine works
When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region 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 utilised 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.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
ARTG details
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.