Omnipaque™ (iohexol) injection

approved since 1985, this low-osmolar iodinated contrast media is indicated for intravenous, intra-arterial, intrathecal, intraarticular, body cavity and oral use¹

Scan after Scan

Two patients injected every second²

Prescribing Confidence

Omnipaque was associated with comparable rates of acute adverse events amongst LOCM in a prospective, randomized, observational study of 8,931 CT patients³

Safe & inclusive

Gluten-free and latex-free & Halal certified4,5

Trusted globally

More than 800 million procedures worldwide and used in more than 130 countries2
ABOUT OMNIPAQUE

Omnipaque has been at least equivalent to any low-osmolar contrast media for either diagnostic efficacy or tolerability at equi-attenuating doses in head-to-head trials.11-20

Patient after patient

Omnipaque provides reliabilty and choice

• Indicated for intravenous, intra-arterial, intrathecal, intraarticular, body cavity and oral uses¹
• Approved for use in both adults and children¹
Scan after scan

Prescribing confidence with Omnipaque

Omnipaque was associated with comparable rates of acute adverse events amongst LOCM In a prospective, randomized, observational study of 8,931 CT patients³
Taste after Taste

Enhancing oral procedures

Omnipaque injection at multiple concentrations is approved for oral use in undiluted form for radiographic imaging of the GI tract.
Omnipaque injection at multiple concentrations is approved for oral use in diluted form for CT of the abdomen in conjunction with Omnipaque injection administered intravenously.

• 81% of adult body CT patients, who expressed a preference for positive oral contrast media, preferred Omnipaque over diatrizoate6
• 98% of paediatric patients undergoing abdominal CT, including patients under 5, drank the required volume of Omnipaque7
Bottle after Bottle

Omnipaque's polymer bottle packaging support departmental efficiency

• Color coded labelling to prevent administration errors
• Important information is repeated upside down so it's easier to read at any angle
• Reducing hazard and downtime with no more broken bottles and injuries from ring pulls8
• Reducing costs and environment impact with less storage space and lower disposal costs8-10

REFERENCES
1. Omnipaque [Product Monograph]. Mississauga, ON: GE HealthCare; 2023
2. Data on file. GE HealthCare Contrast Media Demand; 2020.
3. Gomi T et al. Are there any differences in acute adverse reactions among five low-osmolar non-ionic iodinated contrast media? Eur Radiol. 2010; 10(7):1631-5
4. Data on file, GE HealthCare; 2014.
5. Data on file, Halal Certification; GE HealthCare.
6. McNamara M et al. Oral Contrast Media for Body CT: Comparison of Diatrizoate Sodium and Iohexol for Patient Acceptance and Bowel Opacification. Am J Roentgenol. 2010; 195: 1137–41.
7. Smevik B, Westvik J. Iohexol for Contrast Enhancement of Bowel in Pediatric Abdominal CT. Acta Radiologica. 1990; 31: 601–4.
8. Marshall G. Sharps injuries among radiographers: Dangers associated with opening bottles of contrast agent. Radiography. 2008; 14:128-34
9. Gricar J et al. The Economic and Safety Impact of Glass Versus Polymer Containers in a Radiology Department. Radiology Management. 2007: Sept/Oct 34-42
10. Dhaliwal H et al. A life cycle assessment of packaging options for contrast media delivery: comparing polymer bottle vs. glass bottle. Int J Life Cycle Assess. 2014; 19:1965-73
11. Lamb JT. Iohexol vs. Iopamidol for Myelography. Investigative Radiology. 1985; 20(Suppl.) S37–S43.
12. Rubin CME et al. Comparison of low-osmolar contrast media in paediatric cardiac angiography. British Journal of Radiology. 1987; 60: 133–5.
13. Harding JR et al. A randomized, double-blind, parallel group trial of iomeprol, iohexol and iopamidol in intravenous urography. British Journal of Radiology. 1995; 68: 712–5.
14. Faykus MH et al. Double-Blind Study of the Safety, Tolerance, and Diagnostic Efficacy of Iopromide as Compared with Iopamidol and Iohexol in Patients Requiring Aortography and Visceral Angiography. Invest Radiol. 1994; 29 (Suppl.1): S98–S101.
15. Bischoff W. Clinical Experience with lohexol Versus lopromide in Excretory Urography. Fortschr Röntgenstr. 1989; 128: 108–10.
16. Kaufman AJ et al. Ioversol for Intravenous Urography: A Comparison Study. Urologic Radiology. 1990; 12: 56–60.
17. Cutcliff WB et al. A Double-Blind Comparative Study of the Safety, Tolerability, and Efficacy of Ioversol and Iohexol in Peripheral and Visceral Arteriography. Invest Radiol. 1989; 24 (Suppl.1): S56–9.
18. LaBounty, T et al. Withi-Hospital and 30-Day Outcomes in 107,994 Patients Undergoing Invasive Coronary Angiography With Different Low-Osmolar Iodinated Contrast Media. American Journal of Cardiology. 2012
19. McCullough PA et al. Rate of major adverse renal or cardiac events with iohexol. J Comp Eff Res 2018; 7: 331-41.
20. Dillman JR, al-Hawary M, Ellis JH. Comparative investigation of i.v. iohexol and iopamidol: effect on renal function in low-risk outpatients undergoing CT. AJR Am J Roentgenol. 2012;198:392-397.

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Product Indications and Clinical Use – Omnipaque™ (iohexol injection USP)

Product Indications and Clinical Use – Omnipaque™ (iohexol injection USP)

Adults: Subarachnoid: Omnipaque 240 (iohexol 240 mg I/mL) and Omnipaque 300 (iohexol 300 mg I/mL) are indicated for subarachnoid administration in adults for lumbar, thoracic, cervical and total columnar myelography. Delayed CT scans of the spinal subarachnoid space and of the intracranial CSF spaces may be obtained at the appropriate time following myelography, taking advantage of delayed opacification by the physiological cephalad circulation of the opacified CSF. Intravascular: Omnipaque 350 (iohexol 350 mg I/mL) is indicated in adults for le_ ventriculography, coronary arteriography, intravenous contrast enhancement for computed tomographic head and body imaging, peripheral arteriography, excretory urography, and intravenous digital subtraction arteriography. Omnipaque 300 (iohexol 300 mg I/mL) is indicated in adults for cerebral arteriography, intravenous contrast enhancement for computed tomographic head and body imaging, peripheral arteriography, peripheral venography, and excretory urography. Omnipaque 240 (iohexol 240 mg I/mL) is indicated in adults for intravenous contrast enhancement in computed tomographic head imaging, and for peripheral venography. Arthrography: Omnipaque 300 (iohexol 300 mg I/mL) or Omnipaque 240 (iohexol 240 mg I/mL) is recommended in adults for arthrography of the knee joint. Omnipaque 300 (iohexol 300 mg I/mL) is recommended for arthrography of the shoulder joint in adults. Oral: Omnipaque 300 and Omnipaque 350 are indicated in adults for oral administration for radiographic imaging of the gastrointestinal tract (including esophagus, stomach, small bowel and colon). Omnipaque 240, Omnipaque 300 and Omnipaque 350 diluted to 6 to 9 mg I/mL are indicated for oral administration in adults for CT of the abdomen and pelvis in conjunction with intravenous administration of Omnipaque.

Pediatrics: Intravascular: Omnipaque 350 (iohexol 350 mg I/mL) is indicated in children for angiocardiography. Omnipaque 300 (iohexol 300 mg I/mL) is indicated in children for excretory urography and may be used in infants for angiocardiography. Oral, Rectal, or by Enteric Tube: Omnipaque 240 and Omnipaque 300 are indicated for oral, rectal, or by enteric tube administration for radiographic imaging of the gastrointestinal tract (including esophagus, stomach, small bowel and colon). Omnipaque 240, Omnipaque 300 and Omnipaque 350 diluted to 9 to 29 mg I/mL are indicated for oral administration in children for CT of the abdomen and pelvis in conjunction with intravenous administration of Omnipaque.

CONTRAINDICATIONS

  • Omnipaque (iohexol) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
  • Omnipaque is contraindicated in patients with clinically significant impairment of both hepatic and renal function.

SERIOUS WARNINGS AND PRECAUTIONS BOX

Serious Warnings and Precautions
• The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid reactions should always be considered. The majority of serious undesirable effects occur within the first 30 minutes. Late-onset (that is 1 hour or more after application) hypersensitivity reactions can occur. Patients should be observed for at least 30 minutes after administration of Omnipaque.
• 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.

 

  • Concentration used: Use the recommended Omnipaque concentration for the particular procedure to be performed
  • Caution is advised in patients with:
    • Sickle cell; fluid restriction is not advised in individuals who are homozygous for sickle cell disease
    • Multiple myeloma
    • Severe cardiovascular disease, hyperthyroidism, a history of bronchial asthma or other allergic manifestations, or sensitivity to iodine
    • Pheochromocytoma
    • Endotoxemia or elevated body temperature
  • Elderly and pediatric patients may present a greater risk
  • Thyroid dysfunction: Omnipaque, like all other iodinated contrast media, may induce changes in thyroid function in some patients. Transient hyperthyroidism or hypothyroidism has been reported following iodinated contrast media administration to adult and pediatric patients. Decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased levels of TSH were reported afterer exposure to ICM in infants, especially preterm infants, which remained for up to a few weeks or more than a month. Hypothyroidism in infants may be harmful for growth and development, including mental development, and may require treatment
  • Thyroid function should be checked in neonates following administration of iodinated contrast agents to mothers during pregnancy
  • Contrast media-induced nephrotoxicity. Patients with pre-existing conditions that alter renal function are at increased risk
  • Inaccurate thyroid function tests in the several weeks following radiopaque examination
  • Potential for thyroid storm in patients with hyperthyroidism or autonomously functioning thyroid nodule
  • Risk of severe adverse reactions in patients on adrenergic beta-blockers
  • Risk of clinical deterioration, convulsions, and serious temporary or permanent neurological complications in patients with 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 transit time of the contrast media through the cerebral vasculature is prolonged
  • Caution in dose selection for patients with renal insu_iciency
  • Risk of acute renal failure in patients with pre-existing renal impairment, sepsis, hypotension, dehydration, advanced vascular disease, congestive heart disease, diabetes mellitus, multiple myeloma or other paraproteinacious diseases, the elderly with age-related renal impairment, and those on medications that alter renal function
  • Patients should be adequately hydrated
  • Safety and efficacy not established in pregnant women or those who are breastfeeding

 

Subarachnoid Use: Myelography should not be performed in the presence of infection; caution should be taken with patients on anticonvulsants and at risk of seizures.

Vascular Use: Serious thromboembolic events; patients with serum creatinine above 3 mg/dL; extreme caution with vasopressors; general anesthesia; metformin should be discontinued and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.

Prior to administration, please read the Product Monograph for Omnipaque and the Important Safety Information About Iodinated Contrast Media, which is available by calling Customer Service 1 800 387 7146 or through an email request to canadainfo@ge.com.

Reporting Side Effects
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 to 905 847 5849 to request an adverse events form.

Adverse reactions can also be reported to Health Canada as follows:
• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/mede_ect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

JB01512CA February 2026