CONRAY 43- iothalamate meglumine injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Liebel-Flarsheim Company LLC

INN (שם בינלאומי):

IOTHALAMATE MEGLUMINE

הרכב:

IOTHALAMATE MEGLUMINE 430 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVASCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Conray 43 is indicated for use in lower extremity venography, intravenous infusion urography, contrast enhancement of computed tomographic brain images and arterial digital subtraction angiography. Conray 43 may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Su

leaflet_short:

Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun. As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.

מצב אישור:

New Drug Application

מאפייני מוצר

CONRAY 43- IOTHALAMATE MEGLUMINE INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
AUGUST 2017
CONRAY 43
[IOTHALAMATE MEGLUMINE INJECTION USP 43%]
RX ONLY
NOT FOR INTRATHECAL USE
DESCRIPTION
Conray 43 is a sterile aqueous solution intended for use as a
diagnostic radiopaque medium. Conray 43
contains 43% 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 430 mg of iothalamate meglumine, 0.110 mg
edetate calcium disodium as a
stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer. The
solution provides 20.2% (202
mg/mL) organically bound iodine. Conray 43 has an osmolarity of
approximately 800 mOsmol per liter,
an osmolality of approximately 1000 mOsmol per kilogram and is,
therefore, hypertonic under
conditions of use. The viscosity (cps) is approximately 3 at 25°C and
2 at 37°C. The pH is 6.6 to 7.6.
Conray 43 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
INTRAVASCULAR PROCEDURES
Following intravascular injection, Conray 43 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 43 were approximately 10
and 90 minutes, respectively.
Arteriography and venography may be performed following injection into
an appropriate vessel and will
permit visualization until significant hemodilution occurs.
Following infusion of Conray 43, the upper and lower urinary tract is
opacified. Renal accumulation is
sufficiently rapid