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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  11/21/2018
 
Trade Name:  Spy Agent Green
 
Generic Name or Proper Name (*):  Indocyanine green
 
Indications Studied:  Visualization of vessels, blood flow and tissue perfusion before, during, and after various surgical procedures, including minimally invasive surgeries and visualization of extrahepatic biliary ducts
 
Label Changes Summary:  *Use for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. *Pediatric use for visualization of vessels, blood flow and tissue perfusion is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro and reconstructive procedures, and by clinical trials in adults. *Use for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 to 17 years. *Pediatric use for visualization of extrahepatic biliary ducts is supported by clinical trials in adults in addition to clinical use in pediatric patients. *Use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients less 12 years of age. *Safety and efficacy of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumors has not been established in pediatric patients. *Information on dosing. *New indication and a new route of administration.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novadaq Technologies
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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