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Ultravist® (iopromide) injection

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Ultravist® (iopromide) Injection

Ultravist® is an X-ray contrast medium with a broad range of indications.

Safety & Clinical Trials

INDICATIONS AND CLINICAL USE

Ultravist® (iopromide) in its three strengths, is indicated for intravascular use to provide diagnostic information in a number of radiographic contrast procedures. It is also indicated for the visualization of various body cavities, eg, arthrography and hysterosalpingography.

  • Ultravist® 240 Computed tomography (CT)
    • - Peripheral arteriography (bifemoral pelvis/leg)
    • - Phlebography of the extremities
    • - Cerebral arteriography
    • - Arthrography
    • - 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 angiocardiography
    • - Arthrography

CONTRAINDICATIONS:Ultravist® (iopromide) is not indicated for use in myelography, cerebral ventriculography, and cisternography.Ultravist® should not be administered to patients with known hypersensitivity to the drug, or with manifest hyperthyroidism.

Ultravist® Injection has amassed clinical experience in over 150 million patients. Developed by Bayer Healthcare LLC, Ultravist® Injection was launched in Europe in 1985, and is now in its 25th year as a global brand. Ultravist® Injection is supported by Bayer HealthCare LLC, a world leader in diagnostics serving the radiology community and specialists worldwide.

A clinical trial dataset of 2398 patients was used to generate the adverse drug reaction profile of Ultravist® prior to market authorization in Canada.

Adverse reactions reported with Ultravist® (iopromide) have generally been less frequent than with some commonly used iodinated compounds. Adverse reactions in association with the use of iodinated contrast media are usually mild to moderate and transient in nature.

MOST FREQUENT ARs IN IOPROMIDE GROUP¹
MOST FREQUESTLY REPORTED ADVERSE DRUG REACTIONS
FROM CLINICAL TRIALS
Adverse reactions %
Warmth° Slight to moderate 36.4%
Severe 3.0%
Pain° Slight to moderate 6.1%
Severe 0.4%
Nausea / Vomiting / Diarrhea 2.3%
Urticana 0.8%
Dysguesia 0.4%

May be associated with injection site reaction

Other reported adverse drug reactions (>0.2%) from clinical trials include: hypotension, collapse/loss of consciousness, respiratory symptoms, headache, anxiety, and tachycardia.

The possibility of serious life-threatening reactions should always be considered when administering Ultravist®.

  • The most serious adverse drug reactions in patients receiving Ultravist® are anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal edema, pharyngeal edema, asthma, coma, cerebral infarction, stroke, brain edema, convulsion, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction, cardiac failure, bradycardia, cyanosis, hypotension, shock, dyspnea, pulmonary edema, respiratory insufficiency and aspiration.

Reference: 1. Ultravist® (iopromide injection) Product Monograph. Bayer Inc. November 28, 2014

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Dosing

Dosing

  • Hydrate patients adequately prior to and following the administration of Ultravist® [see Warnings and Precautions in the Product Monograph]
  • Warming Ultravist® to body temperature shortly before administration may help improve tolerability and ease of injection
  • The recommended dosages of Ultravist® should not be exceeded. The volume of each individual injection is a more important consideration than the total dose used.
  • Determine the volume and concentration of Ultravist® to be used, taking into account factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of Ultravist® below doses recommended has not been established.

EXCRETORY UROGRAPHY

Adults

Recommended doses for each concentration of Ultravist®:

  • Ultravist® 300: 40 - 70 mL
  • Ultravist® 370: 30 - 55 mL

The dose may be adjusted in special indications (eg, obese patients, impaired renal function), if necessary.

Children

The physiologically poor concentrating ability of the immature nephron necessitates the administration of relatively high doses of contrast medium in children. The doses of Ultravist® 300 should not exceed:

  • Newborns (< 1 month): 4 mL/kg of body weight equivalent to 1.2 g I/kg.
  • Infants (1 month to 2 years): 3 mL/kg of body weight equivalent to about 1.0 g I/kg.
  • Children (2 to 11 years): 1.5 mL/kg of body weight equivalent to about 0.5 g I/kg.

COMPUTERIZED TOMOGRAPHY ( CT )

Cranial CT

The following doses are recommended and should not be exceeded:

  • Ultravist® 240: 105 - 175 mL
  • Ultravist® 300: 70 - 140 mL
  • Ultravist® 370: 70 - 105 mL

Whole-body CT

In whole-body computerized tomography, the necessary doses of Ultravist® and the rates of administration depend on the organs under investigation, the diagnostic problem and, in particular, the different scan and image reconstruction times of the scanner. Recommended doses for each concentration of Ultravist®:

  • Ultravist® 240: 125 - 180 mL
  • Ultravist® 300: 100 - 150 mL
  • Ultravist® 370: 80 - 120 mL

ANGIOGRAPHY

The dosage of Ultravist® depends on the age, weight, cardiac output and general condition of the patient, the clinical problem, examination technique, and the nature and volume of the vascular region to be investigated. The following dosages may serve as a guide:

Recommended Dosage
Procedure Ultravist Concentration
(mg l/mL)
Usual Recommended Single
Dose (mLlinjection)
Cerebral Arteriography:
Aortic arch angiography 300 40-80
Retrograde carotid angiography 300 30-40
Common carotid 300 6-12
Internal carotid 300 5-12
External carotid 300 4-8
Vertebral artery 300 6-10
Aortography:
Thoracic aortography 300 50-80
Abdominal aortography 300 40-60
Peripheral angiography:
Selective artenography 300 8-12
Aorto-femoral runoffs 300 40-80
Ph lebog ra phy:
240 60-100
300 60-90
Angiocardiography:
Left ventriculography 370 30-60
Coronary artenography 370 5-8

Pediatric Angiography

Ultravist® 370 mg I/mL is indicated for pediatric angiocardiography. Pediatric dosing is suggested proportional to body weight, and based on cardiac output and general condition of the patient, the clinical problem, examination technique, and the nature and volume of the vascular region to be investigated.

ARTHROGRAPHY

Intraarticular injections of contrast media should be monitored by fluoroscopy to ensure adequate injection technique and opacification while preventing over distention of the joint space. Excessive dilution of the contrast medium should be avoided. Recommended doses for procedures of the know using each concentration of Ultravist®:

  • Ultravist® 240: 5 - 11 mL
  • Ultravist® 300: 5 - 11 mL
  • Ultravist® 370: 5 - 11 mL

HYSTEROSALPINGOGRAPHY

Hysterosalpingography contrast media should be instilled into the uterine cavity under controlled pressure with fluoroscopic monitoring of the dose, to avoid excessive injection pressures and doses. Recommended doses for each concentration of Ultravist®:

  • Ultravist® 240: 10 - 25 mL
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Formulation and Packaging

Formulation and Packaging

Ultravist® Injection is available as a stable, ready-to-use aqueous solution of iopromide in vials or bottles in concentrations of 240 mg, 300 mg, and 370 mg iodine per mL. Ultravist® 300 mg and 370 mg iodine per mL is available in a number of vial sizes including the 500 mL Pharmacy Bulk Package.

Packaging

  • Color-coded vials for easy identification of concentration
  • Integrated hanger labels
  • Clear glass vials/bottles for examination of product clarity
  • Peel-off product identification labels
GLASS VIALS (mL) Vial Size
(mL)
PRODUCT CODE
50 81347833

 

50 81347973
100 81348090
150 81348228

 

50 81348295
100 81348325
PHARMACY BULK PACKAGES (mL) Vial Size
(mL)
NDC CODE
200 81347930

 

500 84560529

 

200 81346368
500 84560510
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INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Ultravist® (iopromide) in its three strengths, is indicated for intravascular use to provide diagnostic information in a number of radiographic contrast procedures. It is also indicated for the visualization of various body cavities, eg, arthrography and hysterosalpingography.

Ultravist® 240 Computed tomography (CT)

  • Peripheral arteriography (bifemoral pelvis/leg)
  • Phlebography of the extremities
  • Arthrography
  • 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 angiocardiography
  • Arthrography
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration and Use in Special Populations in the Product Monograph ]

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Ultravist® (iopromide) is not indicated for use in myelography, cerebral ventriculography, and cisternography. Ultravist® should not be administered to patients with known hypersensitivity to the drug, or with manifest hyperthyroidism.

SELECTED WARNINGS AND PRECAUTIONS:

  • Life-threatening or fatal anaphylactoid reactions may occur during or after Ultravist® administration, particularly in patients with allergic disorders.
  • Contrast media-induced nephrotoxicity, presenting as transient impairment of renal function, may occur after intravascular Ultravist® 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.
  • Hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist®.
  • Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure. In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall. The physicochemical properties of the contrast agent, the dose and the speed of injection can influence the reactions.
  • Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of any iodinated contrast agent.
  • Administer iodinated contrast agents with extreme caution in patients with known or suspected pheochromocytoma. Inject the minimal amount of contrast necessary.
  • Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.

MOST COMMON ADVERSE REACTIONS

The most frequently observed adverse drug reactions (>4%) in patients receiving Ultravist® are headache, nausea, and vasodilation.

Please see Product Monograph.