
Packaging
Conray® (iothalamate meglumine injection USP 60%), 282 mg/mL
- 30 mL glass vials package of 25 (0953-23)
- 50 mL glass vials package of 25 (0953-05)
- 150 mL glass vials package of 12 (0953-50)
NOT FOR INTRATHECAL USE |
Indication and Usage
Conray® (Iothalamate Meglumine Injection USP 60%) is a prescription diagnostic radiopaque medium indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray 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. Conray 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, Conray may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT.
Contraindications
Conray should not be used for myelography. Arthrography should not be performed if infection is present in or near the joint. Percutaneous transhepatic cholangiography is contraindicated in patients with coagulation defects and prolonged prothrombin times. Endoscopic retrograde cholangiopancreatography is contraindicated during an acute attack of pancreatitis or during severe clinically evident cholangitis and in patients in whom endoscopy is prohibited. See Warnings and Precautions concerning hypersensitivity.
Warnings and Precautions
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. Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque 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.
Serious neurologic sequelae, including permanent paralysis, have been reported following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. The intravascular injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.
In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported.
Adverse Reactions
The following adverse reactions have been observed in conjunction with the use of iodine-containing contrast agents.
Serious neurological reactions with cerebral angiography include stroke, amnesia and respiratory difficulties.
Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Conray® is used for organ or tissue enhancement in certain CT, X-ray and fluoroscopy imaging procedures for which it is approved.
For more information about Conray®, please see the Full Prescribing Information.
Osmolarity mOsmol/l | Osmolarity mOsmol/kg | mPa*s at 25˚C | Viscosity mPa*s at 37˚C | |
Conray® | 1000 | 1400 | 6 | 4 |
NOT FOR INTRATHECAL USE |
Indication and Usage
Conray® (Iothalamate Meglumine Injection USP 60%) is a prescription diagnostic radiopaque medium indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray 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. Conray 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, Conray may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT.
Contraindications
Conray should not be used for myelography. Arthrography should not be performed if infection is present in or near the joint. Percutaneous transhepatic cholangiography is contraindicated in patients with coagulation defects and prolonged prothrombin times. Endoscopic retrograde cholangiopancreatography is contraindicated during an acute attack of pancreatitis or during severe clinically evident cholangitis and in patients in whom endoscopy is prohibited. See Warnings and Precautions concerning hypersensitivity.
Warnings and Precautions
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. Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque 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.
Serious neurologic sequelae, including permanent paralysis, have been reported following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. The intravascular injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.
In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported.
Adverse Reactions
The following adverse reactions have been observed in conjunction with the use of iodine-containing contrast agents.
Serious neurological reactions with cerebral angiography include stroke, amnesia and respiratory difficulties.
Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Conray® is a registered trademark of Guerbet LLC or its affiliates, and is available by prescription only.
References
1. Conray [package insert]. Princeton NJ: Guerbet LLC; 2017.
GU05201138