Visipaque™ (Iodixanol) Injection

• VISIPAQUE (iodixanol) 320 mg I/mL is indicated for use in angiocardiography (left ventriculography, aortic root injections and selective coronary arteriography) and can be used in the diagnosis of coronary artery disease as well as evaluation of the function of the chambers of the heart and heart valves.

• VISIPAQUE 320 mg I/mL is indicated for visualization of the aorta and its branches and for selective peripheral and visceral arteriography and in diagnosing arterial occlusive diseases, aneurysms, arteriovenous malformations and tumors. It may be used for both conventional radiography and digital subtraction angiography (DSA).
• VISIPAQUE 270 mg I/mL is also indicated for visualization of the aorta and its branches and for selective visceral arteriography and in diagnosing arterial occlusive diseases and tumors.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated in refining diagnostic precision in areas of the brain that may not otherwise be satisfactorily visualized.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidney, aorta, mediastinum, pelvis, abdominal cavity, thoracic space, and retroperitoneal space.
• VISIPAQUE 320 mg I/mL or 270 mg I/mL administered intravenously is indicated in excretory urography to provide diagnostic contrast of the urinary tract and in the diagnosis of prostate enlargement, renal calculi, obstructive uropathy, urinary tract anomalies, neurogenic bladder, and urinary tract malignancies.
• VISIPAQUE 270 mg I/mL administered intravenously is indicated for venography and is useful in the diagnosis of thrombosis, phlebitis, or obstructed venous system.
Important safety information about Visipaque
CONTRAINDICATIONS: Visipaque (iodixanol) should not be administered to patients with known or suspected hypersensitivity to iodixanol.
MOST SERIOUS WARNINGS AND PRECAUTIONS
Concentration Used: Use the recommended Visipaque concentration for the particular procedure to be undertaken.
Fatal Reactions: Serious or fatal reactions have been associated with the administration of water soluble contrast media. It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate facilities and appropriate personnel be readily available in case a severe reaction should occur.
Other serious warnings and precautions:
• Hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid reactions. Patients should be observed for at least 30 minutes after administration.
• Contrast media-induced nephrotoxicity, presenting as transient impairment of renal function, may occur after intravascular Visipaque administration.
• Patients with pre-existing renal impairment, diabetes mellitus, sepsis, hypotension, dehydration, cardiovascular disease, elderly patients, and patients with multiple myeloma, hypertension, patients on medications which alter renal function and patients with hyperuricemia, are at increased risk of this condition. Patients with both renal impairment and diabetes are at the highest risk for contrast media-induced
• Pheochromocytoma
• Sickle cell
• Multiple myeloma
• Coagulation with serious, rarely fatal thromboembolic events
• Use with vasopressors, general anesthesia, metformin, cholecystographic agents, adrenergic beta-blockers, or inotropic agents
• Ensure patients are well hydrated prior to administration
• Patients with a history of allergy, bronchial asthma or other allergic manifestations, combined renal and hepatic disease, the elderly, debilitated or severely ill patients, those with homocystinuria, endotoxemia, elevated body temperature, severe hypertension or congestive heart failure and other cardiovascular diseases, Buergerʼs disease, severe ischemia, suspected thrombosis, ischemic disease, local infection, significantly obstructed vascular system, chronic obstructive pulmonary disease, ventricular failure, pulmonary hypertension, stenotic pulmonary vascular beds, hyperthyroidism and recent renal transplant recipients, as well as patients sensitive to iodine, present an additional risk and call for careful benefit/risk ratio assessment.
• Increased intracranial pressure, cerebral thrombosis or embolism, primary or metastatic cerebral lesions, subarachnoid hemorrhage, arterial spasm, transient ischemic attacks, and in any condition when the blood brain barrier is breached or the transit time of the contrast material through the cerebral vasculature is prolonged.
      • Ensure proper catheter placement
     • Aortic administration
     • Monitor vital signs and ECG through the procedure
     • Myelography and CT scan of the head
     • Breastfeeding
     • Safety and efficacy not established in children
     • Radioactive iodine uptake studies and Multistix® measurements
Prior to administration, please read the Product Monograph for Visipaque and the Important Safety Information About Iodinated Contrast Media, which is available by calling 1 800 654 0118 (option 2, then option 3) or through an email request to canadainfo@ge.com.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1 800 654 0118 (option 2, then option 1), or email canadainfo@ge.com to request an adverse events form, or fax a request for a form to 905 847 5849. Adverse reactions can also be reported to Health Canada as follows:
• Online at MedEffect.com
• By calling 1 866 234 2345 (toll-free)
• By completing a Canada Vigilance Reporting Form and sending it by:
     • Fax to 1 866 678 6789 (toll-free)
     • Mail to Canada Vigilance Program, Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9
     • Postage-paid labels and the Canada Vigilance Reporting Form are available at MedEffect.com