|Manufacturer:||GE Healthcare Inc.|
|Other Info:||Distributed by GE Healthcare Inc.Princeton, NJ 08540Manufactured by GE Healthcare, ASOslo, NorwayVISIPAQUE is a trademark of GE Healthcare .GE and the GE Monogram are trademarks of General Electric Company.Copyright, GE Healthcare Inc., 2006Revised May 2006VNC-1N-OSLO|
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 insure that this drug product is not administered intrathecally.Nonionic, iodinated contrast media inhibit blood coagulation in vitro less than ionic contrast media.
Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.
The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiocardiographic procedures with both ionic and nonionic contrast media.
Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.
Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications, may contribute to the development of thromboembolic events.
For these reasons, meticulous angiographic techniques are recommended, including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions, and minimizing the length of the procedure.Serious or rare fatal reactions have been associated with the administration of iodine-containing radiopaque media.
It is of utmost importance to be completely prepared to treat any reaction associated with the use of any contrast agent.Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered.
(See PRECAUTIONS.)Intravascularly administered iodine-containing radiopaque media are potentially hazardous in patients with multiple myeloma or other paraproteinaceous diseases, who are prone to disease induced renal insufficiency and/or renal failure.
Although neither the contrast agent nor dehydration has been proven to be the cause of renal insufficiency (or worsening renal insufficiency) in myelomatous patients, it has been speculated that the combination of both may be causative.
Special precautions, including maintenance of normal hydration and close monitoring, are required.
Partial dehydration in the preparation of these patients is not recommended since it may predispose the patient to precipitation of the myeloma protein.Reports of thyroid storm following the intravascular use of iodinated radiopaque contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of any contrast agent.Administration of radiopaque materials to patients known to have, or suspected of having, pheochromocytoma should be performed with extreme caution.
If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum.
The blood pressure should be assessed throughout the procedure, and measures for the treatment of hypertensive crisis should be readily available.These patients should be monitored very closely during contrast-enhanced procedures.Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when the agents are administered intravascularly.