IC-GREEN- indocyanine green injection, powder, lyophilized, for solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Indocyanine green (UNII: IX6J1063HV) (Indocyanine Green Acid Form - UNII:C4V974V932)

Commercializzato da:

Novadaq Technologies Inc.

INN (Nome Internazionale):

Indocyanine green

Composizione:

Indocyanine green 25 mg

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. IC‑GREEN™ contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.

Dettagli prodotto:

IC-GREEN™ is supplied in a kit (NDC 75874-701-02) containing six 25 mg IC-GREEN™ vials and six 10 mL Aqueous Solvent ampules: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: Akorn, Inc. Lake Forest, IL 60045 Manufactured for: Novadaq Technologies Inc. Mississauga, ON Canada L4W 4L5 Distributed by: LifeCell Corporation Brachburg, NJ 08876 LCIG00N Rev. 01/11

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

IC-GREEN- INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
NOVADAQ TECHNOLOGIES INC.
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IC GREEN™
(indocyanine green for injection, USP)
Sterile
Rx only
DESCRIPTION
IC GREEN™ is a sterile, lyophilized green powder containing 25 mg of
indocyanine green with no
more than 5% sodium iodide. It is packaged with Aqueous Solvent
consisting of Sterile Water for
Injection used to dissolve the indocyanine green. IC GREEN™ is to be
administered intravenously.
Indocyanine green is a water soluble, tricarbocyanine dye with a peak
spectral absorption at 800 nm.
The chemical name for Indocyanine Green is 1 _H_-Benz[_e_]indolium,
2-[7-[1,3-dihydro-1,1-dimethyl-3-
(4-sulfobutyl)-2_H_-benz[_e_]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide,
inner salt, sodium salt. IC GREEN™ has a pH of approximately 6.5
when reconstituted. Each vial of
IC GREEN™ contains 25 mg of indocyanine green as a sterile
lyophilized powder.
CLINICAL PHARMACOLOGY
Following intravenous injection, IC GREEN™ is rapidly bound to
plasma protein, of which albumin is
the principle carrier (95%). IC 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. IC 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 IC GREEN™ a helpful index of hepatic function.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg
dose has been reported to be
significantly greater in women than in men, although there was no
significant difference in the
calculated value for clearance.
INDICATIONS AND USAGE
For determining cardiac outpu