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ULTRAVIST is a brand name for Iopromide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 01/2020 7 WARNINGS AND PRECAUTIONS 03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES.........................................................................................
2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS.................................................................................................................... 1 Pediatrics ..................................................................................................................
2 Geriatrics................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations....................................................................................................
2 Recommended Dose and Dosage Adjustment................................................................. 4 Administration...............................................................................................................
8 5 OVERDOSAGE................................................................................................................... 9
). 3 Pediatrics, Infants). Assessment of thyroid function may be obscured for several weeks following the administration of ULTRAVIST. Reports of thyroid storm after 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 appropriate patients prior to the use of ULTRAVIST.
For neonates, especially preterm infants, who have been exposed to ULTRAVIST either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as exposure to excess iodine may cause hypothyroidism, possibly requiring treatment.
Patients with pheochromocytoma may be at an increased risk to develop a hypertensive crisis. Administer iodinated contrast agents with extreme caution in patients with known or suspected of having pheochromocytoma. Inject the minimum amount of contrast necessary.
Assess the blood pressure throughout the procedure and have measures for treatment of a hypertensive crisis readily available. Hematologic Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.
Hepatic/Biliary/Pancreatic Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Administration of ULTRAVIST should be postponed in patients who have to undergo oral cholecystography.
Immune Hypersensitivity Before any contrast medium is injected, the patient should be questioned for a history of allergy (eg, shellfish), sensitivity to iodine or to radiographic media, previous reaction to contrast media, and bronchial asthma, as the reported incidence of hypersensitivity/anaphylactoid reactions to contrast media (including severe reactions) are higher in patients with these conditions.
03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES.........................................................................................
2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS.................................................................................................................... 1 Pediatrics ..................................................................................................................
2 Geriatrics................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations....................................................................................................
2 Recommended Dose and Dosage Adjustment................................................................. 4 Administration...............................................................................................................
8 5 OVERDOSAGE................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 9 7 WARNINGS AND PRECAUTIONS .......................................................................................
1 Special Populations...................................................................................................... 1 Pregnant Women ......................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, such reactions are irregular and unpredictable in nature. ULTRAVIST can also be associated with hypersensitivity/anaphylactoid or other idiosyncratic reactions characterized by cardiovascular, respiratory, and cutaneous manifestations.
Hypersensitivity/anaphylactoid reactions ranging from mild to severe reactions including shock are possible (see 8 ADVERSE REACTIONS). Most adverse reactions to contrast agents appear within 30 minutes after the start of their injection, but a delayed reaction may occur hours or days after an injection.
Premedication with a corticosteroid regimen may be considered in patients with an increased risk of acute hypersensitivity/anaphylactoid reactions such as patients with a previous moderate or severe acute reaction, or patients with asthma or an allergy requiring medical treatment.
However, corticosteroids should not be mixed in the same syringe with any contrast medium because of potential ULTRAVIST (iopromide injection) Product Monograph Page 12 of 34 chemical incompatibility. Treatment with beta-blockers or general anesthesia increases the incidence and may aggravate adverse reactions, particularly in people with asthma.
Patients who experience hypersensitivity/anaphylactoid reactions while taking beta-blockers may be resistant to treatment effects of beta agonists. In the event of a severe hypersensitivity/anaphylactoid reaction, patients with cardiovascular disease are more susceptible to serious or even fatal outcomes.
Due to the possibility of severe hypersensitivity/anaphylactoid reactions after administration, postprocedure observation of the patient is recommended. Preparedness for instituting emergency measures is necessary for all patients. Intravascular Use ULTRAVIST produces less circulatory osmotic load than ionic contrast agents; however, it can produce significant hemodynamic disturbances especially in patients with reduced cardiac reserve.
The volume of injection should be minimized and the patient's vital signs should be continuously monitored for several hours following the procedure to detect delayed hemodynamic disturbances in these patients. Hypotension should be corrected promptly as it can lead to serious arrhythmias.
Special care regarding dosage should be observed in patients with right ventricular failure, pulmonary emphysema, pulmonary hypertension or a stenotic pulmonary vascular bed because serious hemodynamic changes may occur in these individuals.
Patients with significant cardiac disease or severe coronary artery disease are at an increased risk of developing clinically relevant hemodynamic changes and arrhythmia. The intravascular injection of ULTRAVIST may precipitate pulmonary edema in patients with heart failure.
Mesenteric necrosis, acute pancreatitis, renal shutdown and serious neurologic complications including spinal cord damage and hemiplegia have been reported following inadvertent injection of a large part of the aortic dose of an ionic contrast medium directly into an aortic branch or arterial trunk.
There are inherent dangers associated with catheter manipulation, contrast medium injection and angiographic procedures. Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure including stroke, brachial plexus palsy, chest pain, myocardial infarction, sinus arrest, and hepato-renal function abnormalities.
For these reasons, meticulous angiographic techniques are recommended, including close attention to guide wire 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.
In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall with resultant pseudoaneurysms, hemorrhage at puncture site, dissection of coronary artery during catheter manipulations and contrast agent injection.
Fluoroscope guidance is to be used to place the catheter. […]
2 Breast-feeding .......................................................................................................... 3 Pediatrics..................................................................................................................
4 Geriatrics .................................................................................................................. 15 8 ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview.......................................................................................... 2 Clinical Trial Adverse Reactions ....................................................................................
5 Post-Market Adverse Reactions.................................................................................... 17 9 DRUG INTERACTIONS .....................................................................................................
2 Drug Interactions Overview.......................................................................................... 4 Drug-Drug Interactions.................................................................................................
5 Drug-Food Interactions ................................................................................................ 6 Drug-Herb Interactions ................................................................................................
7 Drug-Laboratory Test Interactions ................................................................................ 20 10 CLINICAL PHARMACOLOGY ..........................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics....................................................................................................... 21 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
21 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 22 PART II: SCIENTIFIC INFORMATION ...................................................................................
23 13 PHARMACEUTICAL INFORMATION ............................................................................... 23 14 CLINICAL TRIALS ...........................................................................................................
24 15 MICROBIOLOGY ........................................................................................................... 24 16 NON-CLINICAL TOXICOLOGY.........................................................................................
24 PATIENT MEDICATION INFORMATION .............................................................................. 28 ULTRAVIST (Iopromide Injection) Product Monograph Page 4 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ULTRAVIST (iopromide), provided as 300 mg I/mL and 370 mg I/mL, is indicated for: Intravascular use to provide diagnostic information in a number of radiographic contrast procedures.
Visualization of various body cavities, eg, arthrography and hysterosalpingography. ULTRAVIST 300 Computed tomography (CT) Excretory urography Pediatric excretory urography Renal arteriography Peripheral arteriography (bifemoral pelvis/leg) Cerebral arteriography Phlebography of the extremities Arthrography ULTRAVIST 370 Computed tomography (CT) Excretory urography Coronary arteriography (including PTCA), with or without left ventriculography Pediatric […]