Ultravist

ULTRAVIST- iopromide injection
Bayer HealthCare Pharmaceuticals Inc.

WARNING: NOT FOR INTRATHECAL USE

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications (4)].

1 INDICATIONS AND USAGE

ULTRAVIST® Injection is an iodinated contrast agent indicated for:

1.1 Intra-Arterial Procedures*

300 mg Iodine per mL for cerebral arteriography and peripheral arteriography
370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography

1.2 Intravenous Procedures*

300 mg Iodine per mL for excretory urography
300 mg Iodine per mL and 370 mg Iodine per mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal 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 (2.3) and Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

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. As ULTRAVIST Injection is a highly concentrated solution, crystallization (milky-cloudy appearance and/or sediment at bottom, or floating crystals) may occur.
Use sterile technique for all handling and administration of ULTRAVIST.
Determine the volume and concentration of ULTRAVIST Injection to be used considering 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.
Administer ULTRAVIST at or close to body temperature.
Do not mix or inject ULTRAVIST Injection in intravenous administration lines containing other drugs or total nutritional admixtures. ULTRAVIST can be mixed with saline when used in a power injector suitable for simultaneous injection of contrast and saline [see Dosage and Administration ( 2.2)].
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, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions (5.2)].

2.1 Intra-Arterial Procedures

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 Iodine per mL), Coronary Arteriography and Left Ventriculography (370 mg Iodine per mL), Peripheral Arteriography (300 mg Iodine per mL),: see Table 1.
Aortography and Visceral Angiography (370 mg Iodine per 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 Intra-Arterial Procedures

Cerebral Arteriography

(300 mg Iodine per mL)

Peripheral Arteriography

(300 mg Iodine per mL)

Coronary Arteriography and
Left Ventriculography

(370 mg Iodine per mL)

Intra-Arterial Injection Sites

Carotid Arteries

Vertebral Arteries

Aortic Arch Injection (4 vessel study)

3 ml to 12 mL

4 ml to 12 mL

20 ml to 50 mL

-

-

-

-

-

-

Right Coronary Artery

Left Coronary Artery

Left Ventricle

-

-

-

-

-

-

3 ml to 14 mL

3 ml to 14 mL

30 ml to 60 mL

Aorta

Major Branches of the Abdominal Aorta

-

-

-

-

-

-

Subclavian or Femoral Artery

Aortic Bifurcation (distal runoff)

-

-

5 ml to 40 mL

25 ml to 50 mL

-

-

Maximum Total Dose

150 mL

250 mL

225 mL

2.2 Intravenous Procedures

Contrast Computed Tomography (CT) (300 mg Iodine per mL and 370 mg Iodine per mL) and Excretory Urography (300 mg Iodine per mL): see Table 2.
Table 2: Suggested ULTRAVIST Injection Dosing for Adult Intravenous Contrast Administration

Excretory Urography (300 mg Iodine per mL)

Contrast Computed Tomography (300 mg Iodine per mL)

Contrast Computed Tomography
(370 mg Iodine per mL)

Excretory Urography

Approximately 300 mg Iodine per kg body wt. (Adults with normal renal function)

-

-

Head

-

50 ml to 200 mL

41 ml to 162 mL

Body

Single Phase Contrast

Bolus Injection

-

50 ml to 200 mL

41 ml to 162 mL

Rapid Infusion

-

100 ml to 200 mL

81 ml to 162 mL

Body
Multiple Phase Contrast

50 ml to 200 mL total volume
Phase 1: 100% contrast
Phase 2: 20-60% contrast
using a power injector suitable for simultaneous injection

41 ml to 162 mL total volume
Phase 1: 100% contrast
Phase 2: 20-60% contrast
using a power injector suitable for simultaneous injection

Maximum Total Dose

100 mL (30 g iodine)

200 mL (60 g iodine)

162 mL (60 g iodine)

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