CYSTO-CONRAY II- iothalamate meglumine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Liebel-Flarsheim Company LLC

INN (International Name):

IOTHALAMATE MEGLUMINE

Composition:

IOTHALAMATE MEGLUMINE 172 mg in 1 mL

Administration route:

URETERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography. See WARNINGS concerning inadvertant intrathecal administration.

Product summary:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers 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 product 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. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616  Made in USA GBT 0862A0817 Revised 08/17      Guerbet

Authorization status:

New Drug Application

Summary of Product characteristics

CYSTO-CONRAY II- IOTHALAMATE MEGLUMINE INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
AUGUST 2017
CYS TO-CONRAY II
[IOTHALAMATE MEGLUMINE INJECTION USP 17.2%]
RX ONLY
NOT FOR INTRAVASCULAR ADMINISTRATION
NOT FOR INTRATHECAL USE
DESCRIPTION
Cysto-Conray II is a sterile aqueous solution intended for
instillation as a diagnostic radiopaque
medium. Cysto-Conray II contains 17.2% 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 of Cysto-Conray II contains 172 mg of iothalamate
meglumine, equivalent to 81 mg
(8.1% w/v) of organically bound iodine, 0.110 mg edetate calcium
disodium as a stabilizer and 0.115 mg
of monobasic sodium phosphate as a buffer.
Cysto-Conray II is hypertonic under conditions of use and is supplied
in containers from which the air
has been displaced by nitrogen. The pH of Cysto-Conray II is
6.6 to 7.6.
CLINICAL PHARMACOLOGY
The most important characteristic of contrast media is the iodine
content. The relatively high atomic
weight of iodine contributes sufficient radiodensity for radiographic
contrast.
Following instillation by sterile catheter, Cysto-Conray II provides
for visualization of the lower
urinary tract. Clinical literature reports indicate that routinely
less than 1 percent of a retrograde
urographic radiopaque is absorbed systemically, however, as much as 12
percent absorption was
observed with pyelorenal back flow and may produce iodine medicated
thyrotropic effects described
under PRECAUTIONS.
®
INDICATIONS AND USAGE
Cysto-Conray II is indicated for use in retrograde cystography and
cystourethrography.
CONTRAINDICATIONS
See WARNINGS concerning inadvertant intrathecal administration.
WARNINGS
SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION:
Serious adverse reactions have been reported due to the inadvertent
intrathecal administration of
iodinated contrast media that are not indicated for intrathecal use.
These serious adverse rea