CONRAY 30 iothalamate meglumine injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

IOTHALAMATE MEGLUMINE (UNII: XUW72GOP7W) (IOTHALAMIC ACID - UNII:16CHD79MIX)

Mevcut itibaren:

Liebel-Flarsheim Company LLC

INN (International Adı):

IOTHALAMATE MEGLUMINE

Kompozisyon:

IOTHALAMATE MEGLUMINE 300 mg in 1 mL

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

CONRAY 30- IOTHALAMATE MEGLUMINE INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
MARCH 2017
CONRAY 30
(IOTHALAMATE MEGLUMINE INJECTION USP 30%)
NOT FOR INTRATHECAL USE
DESCRIPTION
Conray 30 is a sterile aqueous solution intended for use as a
diagnostic radiopaque medium. Conray 30
contains 30% w/v iothalamate meglumine which is
1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-
2,4,6 triiodo-N-methylisophthalamate (salt), and has the following
structural formula:
Each milliliter contains 300 mg of iothalamate meglumine, 0.110 mg
edetate calcium disodium as a
stabilizer and 0.125 mg of monobasic sodium phosphate as a buffer. The
solution contains
approximately 0.04 mg sodium in each milliliter (12 mg/300 mL) and
provides 14.1% (141 mg/mL)
organically bound iodine (42.3 grams/300 mL). Conray 30 has an
osmolarity of approximately 500
mOsmol per liter, an osmolality of approximately 600 mOsmol per
kilogram and is, therefore,
hypertonic under conditions of use. The viscosity (cps) is
approximately 2 at 25°C and 1.5 at 37°C. The
pH is 6.5 to 7.7.
Conray 30 is a clear solution containing no undissolved solids.
Crystallization does not occur at normal
room temperatures. It is supplied in containers from which the air has
been displaced by nitrogen.
CLINICAL PHARMACOLOGY
Following intravascular injection, Conray 30 is rapidly transported
through the circulatory system to the
kidneys and is excreted unchanged in the urine by glomerular
filtration. The pharmacokinetics of
intravascularly administered radiopaque contrast media are usually
best described by a two compartment
model with a rapid alpha phase for drug distribution and a slower beta
phase for drug elimination. In
patients with normal renal function, the alpha and beta half-lives of
Conray 30 were approximately 10
and 90 minutes, respectively.
Following infusion of Conray 30, the upper and lower urinary tract is
opacified. Renal accumulation is
sufficiently rapid that maximum radiographic density in the calyces
and pelves occurs by the time the
infusion is complet