Cysto-Conray II
Generic: IOTHALAMATE MEGLUMINE
Basic Information
Manufacturer
Liebel-Flarsheim Company LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
URETERAL
FDA Set ID
8841ab4d-674d-4beb-88a5-13e35f6005cc
Indications & Usage
INDICATIONS AND USAGE Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
Warnings
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 reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Special attention must be given to ensure that this drug product is not administered intrathecally.
These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Special attention must be given to ensure that this drug product is not administered intrathecally.
Adverse Reactions
ADVERSE REACTIONS Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur.
As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.
As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.
Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection.
In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.