Ultravist
ULTRAVIST- iopromide injection
Bayer HealthCare Pharmaceuticals Inc.
1 INDICATIONS AND USAGE
ULTRAVIST® Injection is an iodinated contrast agent indicated for:
1.1 Intra-Arterial Procedures*
ULTRAVIST is indicated for:
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- Cerebral arteriography and peripheral arteriography in adults
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- Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults
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- Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older
1.2 Intravenous Procedures*
ULTRAVIST is indicated for:
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- Excretory urography in adults and pediatric patients aged 2 years and older
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- Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older
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- Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound
† Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2, 2.3, 2.4)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
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- ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1)].
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- Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ( 2.2, 2.3, 2.4)].
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- Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions ( 5.3)].
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- Individualize the volume, concentration, and injection rate of ULTRAVIST according to the specific dosing tables [see Dosage and Administration ( 2.2, 2.3, 2.4)]. Consider factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; also consider extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
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- Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter (including crystals) and/or discoloration is observed or if containers are defective.
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- Use aseptic technique for all handling and administration of ULTRAVIST.
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- Warm ULTRAVIST to body temperature before administration.
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- ULTRAVIST can be used with 0.9% Sodium Chloride Injection in a power injector suitable for simultaneous injection of contrast [see Dosage and Administration ( 2.3)]. However, do not mix or inject ULTRAVIST in intravenous administration lines containing other drugs or total nutritional admixtures.
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- Discard any unused portion remaining in the single-dose container following initial use.
2.2 Recommended Dosage for Intra-Arterial Procedures in Adults
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- The recommended doses for intra-arterial procedures in adults are shown in Table 1.
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- Inject at rates approximately equal to the flow rate in the vessel being injected.
Imaging Procedure | Cerebral Arteriography | Peripheral Arteriography | Coronary Arteriography and | Visceral Angiography and Aortography | |
Concentration (mg Iodine per mL) | 300* | 300* | 370* | 370* | |
Intra-Arterial Injection Sites | Carotid Arteries | 3 mL to 12 mL | – | – | – |
Vertebral Arteries | 4 mL to 12 mL | ||||
Aortic Arch Injection (four vessel study) | 20 mL to 50 mL | ||||
Subclavian or Femoral Artery | – | 5 mL to 40 mL | – | – | |
Aortic Bifurcation (distal runoff) | 25 mL to 50 mL | ||||
Right Coronary Artery | – | – | 3 mL to 14 mL | – | |
Left Coronary Artery | 3 mL to 14 mL | ||||
Left Ventricle | 30 mL to 60 mL | ||||
Aorta and Major Abdominal Branches | – | – | – | Individualize a volume approximately equal to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. | |
Maximum Total Dose | 150 mL | 250 mL | 225 mL | 225 mL |
*Use single-dose vials or pharmacy bulk package.
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