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Optiray (Ioversol Intravascular) - Summary

 
 



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 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.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic 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. 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 or 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 contrast medium reaction.

As with any contrast medium, serious neurologic sequelae, including permanent paralysis, can occur following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. A cause-effect relationship to the contrast medium has not been established since the patients' pre-existing condition and procedural technique are causative factors in themselves. The arterial injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.

Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered.

Intravascularly administered iodine-containing radiopaque media are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Myeloma occurs most commonly in persons over age 40. Although neither the contrast agent nor dehydration has been proved separately to be the cause of anuria in myelomatous patients, it has been speculated that the combination of both may be causative. The risk in myelomatous patients is not a contraindication to the procedure; however, special precautions, including maintenance of normal hydration and close monitoring, are required. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein.

Administration of radiopaque materials to patients known 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 treatment of a hypertensive crisis should be available.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.

Reports of thyroid storm following the intravascular use of iodinated radiopaque 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 medium.

 

OPTIRAY SUMMARY

OPTIRAY (ioversol injection) formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular administration as diagnostic radiopaque media. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.

OPTIRAY 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. OPTIRAY 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. OPTIRAY 350 is indicated in children for angiocardiography.

OPTIRAY 320 is indicated in adults for angiography throughout the cardiovascular system. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. OPTIRAY 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

OPTIRAY 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

OPTIRAY 300 is indicated for cerebral angiography and peripheral arteriography. OPTIRAY 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography.

OPTIRAY 240 is indicated for cerebral angiography and venography. OPTIRAY 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography.


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NEWS HIGHLIGHTS

Media Articles Related to Optiray (Ioversol Intravascular)

Contaminated blood cultures can serve as diagnostic predictor for more targeted antibiotics
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IVD clinical and regulatory quiz - participants receive discount on Clinical Affairs and Regulatory Approvals for Diagnostics conference registration
Source: Conferences News From Medical News Today [2014.08.28]
Diagnostic clinical and regulatory professionals are now eligible to receive a discount to the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 27-29, 2014...

APOE, diagnostic accuracy of CSF biomarkers for Alzheimer disease
Source: Psychology / Psychiatry News From Medical News Today [2014.08.27]
Cerebral spinal fluid (CSF) levels of β-amyloid 42(Aβ42) are associated with the diagnosis of Alzheimer disease (AD) and (Aβ) accumulation in the brain independent of apolipoprotein E (APOE)...

A novel "Man and Machine" decision support system makes malaria diagnostics more effective
Source: Medical Devices / Diagnostics News From Medical News Today [2014.08.22]
A Finnish-Swedish research group at the Institute for Molecular Medicine Finland (FIMM), University of Helsinki, and Karolinska institutet, Stockholm, has developed a novel "man and machine"...

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Published Studies Related to Optiray (Ioversol Intravascular)

A very rare case of encephalopathy in a patient with end-stage renal disease: contrast agent, ioversol. [2010]
Contrast agents are associated with a number of adverse effects, including central nervous system effects... Patients with end-stage renal disease may be at an increased risk of adverse effects of contrast agents.

Ioversol-induced acute generalized exanthematous pustulosis: a case report. [2009.06]
BACKGROUND: Acute generalized exanthematous pustulosis (AGEP) is a relatively rare exfoliative dermatosis consisting of a generalized eruption of sterile, nonfollicular pustules arising on widespread erythematous and edematous skin that is usually caused by drugs...

Nephrotoxicity of iodixanol versus ioversol in patients with chronic kidney disease: the Visipaque Angiography/Interventions with Laboratory Outcomes in Renal Insufficiency (VALOR) Trial. [2008.10]
BACKGROUND: Iso-osmolar contrast medium iodixanol has been reported to be less nephrotoxic than selected low-osmolar contrast media (LOCM) in chronic kidney disease (CKD) patients with diabetes mellitus. This study compared the nephrotoxicity of iodixanol and the LOCM ioversol in CKD patients undergoing coronary angiography... CONCLUSIONS: Overall, the nephrotoxicity associated with iodixanol was not significantly different from that observed with ioversol in CKD patients undergoing coronary angiography, although in diabetic patients, MPPC was significantly lower in the iodixanol group.

Fatal anaphylactoid reaction following ioversol administration. [2007.12]
We report a fatal intravenous ioversol administration in a 60-year old male patient. Although the introduction of new low-osmolar non-ionogenic contrast media with a more favourable efficacy-toxicity balance has diminished the side-effects significantly, everyone involved in radiodiagnostic procedures should be aware of the potential life-threatening effects.

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Clinical Trials Related to Optiray (Ioversol Intravascular)

Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography [Recruiting]

Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography [Terminated]

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Page last updated: 2014-08-30

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