Indications
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
Contraindications
Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis. ( 4 )
Warnings and precautions
- Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization. ( 5.1 )
- Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours. ( 5.2 )
- Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP. ( 5.3 )
5.1Anaphylaxis Deaths
At a glance
- Brand name
- Indocyanine Green
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Renew Pharms
- Status
- Prescription
- FDA approval
- 21 Nov 2007
- Application
- ANDA040811-001