"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
ULTRAVIST® Injection is an iodinated contrast agent indicated for:
- 150 mg I/mL for intra-arterial digital subtraction angiography (IA-DSA)
- 300 mg I/mL for cerebral arteriography and peripheral arteriography
- 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
- 240 mg I/mL for peripheral venography
- 300 mg I/mL for excretory urography
- 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intraabdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
*For information on the concentrations and doses for the Pediatric Population [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].
DOSAGE AND ADMINISTRATION
- Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter and/or discoloration is observed.
- Determine the volume and concentration of ULTRAVIST Injection 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. Specific dose adjustments for age, gender, weight and renal function have not been studied for ULTRAVIST Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of ULTRAVIST Injection below doses recommended has not been established.
- The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.
- Hydrate patients adequately prior to and following the administration of ULTRAVIST [see WARNINGS AND PRECAUTIONS].
- Warming Ultravist to body temperature shortly before administration may help improve tolerability and ease of injection [see HOW SUPPLIED/Storage and Handling].
The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.
- Cerebral Arteriography (300 mg I/mL), Coronary Arteriography and Left Ventriculography (370 mg I/mL), Peripheral Arteriography (300 mg I/mL), Intra-arterial Digital Subtraction Angiography (IA-DSA) (150 mg I/mL): see Table 1.
- Aortography and Visceral Angiography (370 mg I/mL):
Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.
Table 1: Suggested Single Injection Doses for Adult
|IA-DSA* (150 mg I/mL)||Cerebral Arteriography (300 mg I/mL)||Peripheral Arteriography (300 mg I/mL)||Coronary Arteriography and Left Ventriculography (370 mg I/mL)|
|Intra-Arterial Injection Sites||Carotid Arteries||6-10 mL||3-12 mL||-||-|
|Vertebral Arteries||4-8 mL||4-12 mL||-||-|
|Aortic Arch Injection (4 vessel study)||-||20-50 mL||-||-|
|Right Coronary Artery||-||-||-||3-14 mL|
|Left Coronary Artery||-||-||-||3-14 mL|
|Left Ventricle||-||-||-||30-60 mL|
|Major Branches of the Abdominal Aorta||2-20 mL||-||-||-|
|Subclavian or Femoral Artery||-||-||5-40 mL||-|
|Aortic Bifurcation (distal runoff)||-||-||25-50 mL||-|
|Maximum Total Dose||250 mL||150 mL||250 mL||225 mL|
|*IA-DSA = Intra-Arterial Digital Subtraction Angiography|
- Peripheral Venography (240 mg I/mL):
Inject the minimum volume necessary to visualize satisfactorily the structures under examination. Do not exceed 250 mL as total dose for the procedure.
- Contrast Computed Tomography (CT) (300 mg I/mL and 370 mg I/mL) and Excretory Urography (300 mg I/mL): see Table 2.
Table 2: Suggested ULTRAVIST Injection Dosing for Adult
Intravenous Contrast Administration
|Excretory Urography (300 mg I/mL)||Contrast Computed Tomography (300 mg I/mL)||Contrast Computed Tomography (370 mg I/mL)|
|Excretory Urography||Approximately 300 mg I/kg body wt. (Adults with normal renal function)||-||-|
|Head||-||50-200 mL||41-162 mL|
|Bolus Injection||50-200 mL||41-162 mL|
|Rapid Infusion||100-200 mL||81-162 mL|
|Maximum Total Dose||100 mL (30 g iodine)||200 mL (60 g iodine)||162 mL (60 g iodine)|
The recommended dose in children over 2 years of age for the following evaluations is:
Cardiac chambers and related arteries (370 mg I/mL)
Inject 1 to 2 milliliters per kilogram (mL/kg). Do not exceed 4 mL/kg as total dose.
Contrast Computerized Tomography or Excretory Urography (300 mg I/mL)
Inject 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.
Dosage Forms And Strengths
ULTRAVIST Injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.
ULTRAVIST Injection is available in four strengths:
150 mg I/mL provides 311.7 mg/mL
240 mg I/mL provides 498.72 mg/mL iopromide,
300 mg I/mL provides 623.4 mg/mL iopromide,
370 mg I/mL provides 768.86 mg/mL iopromide.
Storage And Handling
ULTRAVIST Injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in four strengths.
|Glass Vials||NDC Number|
|ULTRAVIST Injection 150 mg I/mL|
|10 x 50 mL vials||50419-340-05|
|ULTRAVIST Injection 240 mg I/mL|
|10 x 50 mL vials||50419-342-05|
|10 x 50 mL vials (RFID)||50419-342-41|
|10 x 100 mL vials||50419-342-10|
|10 x 100 mL vials (RFID)||50419-342-43|
|ULTRAVIST Injection 300 mg I/mL|
|10 x 50 mL vials||50419-344-05|
|10 x 50 mL vials (RFID)||50419-344-41|
|10 x 75 mL fill/100 mL vials||50419-344-07|
|10 x 100 mL vials||50419-344-10|
|10 x 100 mL vials (RFID)||50419-344-43|
|10 x 125 mL fill/150 mL vials||50419-344-12|
|10 x 150 mL vials||50419-344-15|
|ULTRAVIST Injection 370 mg I/mL|
|10 x 50 mL vials||50419-346-05|
|10 x 50 mL vials (RFID)||50419-346-41|
|10 x 75 mL fill/100 mL vials||50419-346-07|
|10 x 100 mL vials||50419-346-10|
|10 x 100 mL vials (RFID)||50419-346-43|
|10 x 125 mL fill/150 mL vials||50419-346-12|
|10 x 150 mL vials||50419-346-15|
|10 x 150 mL vials (RFID)||50419-346-45|
|10 x 200 mL fill/250 mL vials||50419-346-20|
Inspect ULTRAVIST visually prior to use. Do not use if discolored, if particulate matter (including crystals) is present, or if containers are defective. As ULTRAVIST Injection is a highly concentrated solution, crystallization (milky-cloudy appearance and/or sediment at bottom, or floating crystals) may occur.
As with all contrast agents, because of the potential for chemical incompatibility, do not mix or inject ULTRAVIST Injection in intravenous administration lines containing other drugs, solutions or total nutritional admixtures.
Administer ULTRAVIST at or close to body temperature.
If nondisposable equipment is used, take scrupulous care to prevent residual contamination with traces of cleansing agents.
Withdraw ULTRAVIST from its container under strict aseptic conditions using only sterile syringes and transfer devices. Use immediately contrast agents which have been transferred into other delivery systems.
Store ULTRAVIST at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light.
Mfd. for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Mfd. in Germany. Revised 05/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/24/2012
Additional Ultravist Information
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