INDOCYANINE GREEN- indocyanine green and water kit

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

INDOCYANINE GREEN (UNII: IX6J1063HV) (INDOCYANINE GREEN ACID FORM - UNII:C4V974V932)

থেকে পাওয়া:

HUB Pharmaceuticals LLC

INN (আন্তর্জাতিক নাম):

INDOCYANINE GREEN

রচনা:

INDOCYANINE GREEN 25 mg

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Indocyanine Green for Injection USP, is supplied in a kit, (NDC 17238-424-02) containing six 25-mg Indocyanine Green for Injection USP vials and six 10-mL Sterile Water for Injection vials: NDC 17238-424-01 Indocyanine Green for Injection 25-mg fill in 30-mL vial. NDC 63323-185-10 (or NDC 0409-4887-17) Sterile Water for Injection 10-mL fill in 10-mL vial.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

INDOCYANINE GREEN- INDOCYANINE GREEN AND WATER
HUB PHARMACEUTICALS LLC
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INDOCYANINE GREEN FOR INJECTION USP
RX ONLY
DESCRIPTION
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)-2 _H_-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 been
reported to be significantl