INDOCYANINE GREEN kit INDOCYANINE GREEN injection, powder, lyophilized, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Indocyanine green (UNII: IX6J1063HV) (Indocyanine green - UNII:IX6J1063HV)

Доступна з:

Novadaq Technologies Inc.

ІПН (Міжнародна Ім'я):

Indocyanine green

Склад:

Indocyanine green 25 mg

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.

Огляд продуктів:

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 75874-424-01: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: LifeCell Corporation Brachburg, NJ 08876 Sterile Water for Injection USP is Manufactured by: Abraxis Pharmaceutical Products Schaumburg, IL 60173 Oct 2011/Rev.00 Cod. 251316

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

INDOCYANINE GREEN- INDOCYANINE GREEN
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