Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
Indocyanine green (UNII: IX6J1063HV) (INDOCYANINE GREEN ACID FORM - UNII:C4V974V932)
Novadaq Technologies Inc.
Indocyanine green
Indocyanine green 25 mg
INTRAVENOUS
PRESCRIPTION DRUG
For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. Indocyanine Green for Injection USP contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.
Indocyanine Green for Injection USP. is supplied in a kit, containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL sterile Water for Injection vials: NDC 49673-424-01 Indocyanine Green for Injection USP 25-mg filled in 30 mL vial. NDC 63323-185-10 Sterile Water for Injection 10-mL fill in 10-mL vial. Store at 20° to 25° C [68 to 77 °F). [See USP Controlled Room Temperature.] Rx only Manufactured by: Patheon Italia S.p.A. Viale G.B. Stucchi 110 20900 Monza (MB) ITALY and Pulsion Medical Systems SE Hans-Riedl-Straβe 17 D-85622 Feldkirchen, Germany Manufactured for Novadaq Technologies Inc. Richmond, BC V6V 2A2 Canada Distributed by: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 Sterile Water for Injection USP is Manufactured by: Abraxis Pharmaceutical Products Schaumburg, IL 60173 Apr 2012/Rev.00 Cod. 251332
Abbreviated New Drug Application
INDOCYANINE GREEN- INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NOVADAQ TECHNOLOGIES INC. ---------- INDOCYANINE GREEN FOR INJECTION USP RX ONLY DES CRIPTION: Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously. Indocyanine green is a water-soluble, tricarbocyanine dye with peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1H-benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4- sulfobutyl)-2H-benz[e]indo-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium, or 2-[7-[1,1-dimethyl-3-(4-sulfobutyl)benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl]- 1,1-dimethyl-3-(4-sulfobutyl)-1H-benz[e]indolium hydroxide, inner salt, sodium salt. Indocyanine Green for Injection USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection USP contains 25 mg of indocyanine green as a sterile lyophilized powder. CLINICAL PHARMACOLOGY: Following intravenous injection, Indocyanine Green is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). Indocyanine Green undergoes no significant extrahepatic or enterohepatic circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Indocyanine Green is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make Indocyanine Green a helpful index of hepatic function. The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has be Прочитайте повний документ