Indocyanine Green
Generic: INDOCYANINE GREEN AND WATER
Basic Information
Manufacturer
Olympus America, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
91c206e8-fab9-4bf3-afcf-304eddf0d54e
Indications & Usage
1 INDICATIONS AND USAGE Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system ( 1.1 ) • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system ( 1.2 ) • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system ( 1.3 ) 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system 1.2 Visual assessment of the major extrahepatic bile duct For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system.
1.3 Viewing intra-operative blood flow in the cerebral area For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system
1.3 Viewing intra-operative blood flow in the cerebral area For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system
Adverse Reactions
6 ADVERSE REACTIONS Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides.
If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids.
Most common adverse reactions are anaphylactic or urticarial reactions.
These have been reported in patients with and without a history of allergy to iodides.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@ diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids.
Most common adverse reactions are anaphylactic or urticarial reactions.
These have been reported in patients with and without a history of allergy to iodides.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@ diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.