Ultravist

ULTRAVIST- iopromide injection
Bayer HealthCare Pharmaceuticals Inc.

WARNING: NOT FOR INTRATHECAL USE

1 INDICATIONS AND USAGE

ULTRAVIST® Injection is an iodinated contrast agent indicated for:

1.1 Intra-Arterial Procedures*

ULTRAVIST is indicated for:

Cerebral arteriography and peripheral arteriography in adults
Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults
Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older

1.2 Intravenous Procedures*

ULTRAVIST is indicated for:

Excretory urography in adults and pediatric patients aged 2 years and older
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
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

ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1)].
Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ( 2.2, 2.3, 2.4)].
Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions ( 5.3)].
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.
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.
Use aseptic technique for all handling and administration of ULTRAVIST.
Warm ULTRAVIST to body temperature before administration.
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.
Discard any unused portion remaining in the single-dose container following initial use.

2.2 Recommended Dosage for Intra-Arterial Procedures in Adults

The recommended doses for intra-arterial procedures in adults are shown in Table 1.
Inject at rates approximately equal to the flow rate in the vessel being injected.
Table 1: Recommended Concentrations and Volume of ULTRAVIST to Administer per Single Injection for Selected Injection Sites of Intra-Arterial Procedures in Adults

Imaging Procedure

Cerebral Arteriography

Peripheral Arteriography

Coronary Arteriography

and
Left Ventriculography

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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