Ultravist

ULTRAVIST- iopromide injection
Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

ULTRAVIST^® injection is an iodinated contrast agent indicated In

Adults

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For 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.

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The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.

Pediatric Patients

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For Computed Tomography (CT) of the head and body

For use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

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ULTRAVIST IMAGING BULK PACKAGE is for intravenous use only not for direct infusion.

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Visually inspect ULTRAVIST injection for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST injection 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.

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Use sterile technique for all handling and administration of ULTRAVIST.

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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.

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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)].

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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.

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Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST injection [see Warnings and Precautions (5.2)].

2.2 Intravenous Procedures

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Computed Tomography (CT) (300 mg Iodine per mL and 370 mg Iodine per mL): see Table 1.

Table 1: Suggested ULTRAVIST injection Dosing for Adult Intravenous Contrast Administration
	Contrast Computed Tomography (300 mg Iodine per mL)	Contrast Computed Tomography (370 mg Iodine per mL)
Head	50 ml to 200 mL	41 ml to 162 mL
Body Single Contrast Phase
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 of contrast and saline	41 ml to 162 mL total volume Phase 1: 100% contrast, Phase 2: 20-60% contrast, using a power injector suitable for simultaneous injection of contrast and saline
Maximum Total Dose	200 mL (60 g iodine)	162 mL (60 g iodine)

2.3 Pediatric Dosing

The recommended dose in children over 2 years of age for Computerized Tomography of the head and body (300 mg Iodine per mL):

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1 to 2 milliliters per kilogram (mL/kg) injected intravenously.

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[see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

Do not exceed the adult dose (200 mL)

2.4 Imaging Bulk Package Preparation Instructions

ULTRAVIST Imaging Bulk Package is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. Please see drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.

1.

The ULTRAVIST Imaging Bulk Package is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

2.

Utilize aseptic technique for penetrating the container closure of the ULTRAVIST Imaging Bulk Package and transferring ULTRAVIST injection. The container closure may be penetrated only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this this Imaging Bulk Package.

3.

Once the ULTRAVIST Imaging Bulk Package is punctured, do not be remove it from the work area during the entire period of use. Maintain the bottle in an inverted position such that container contents are in continuous contact with the dispensing set.

4.

A maximum use time of 10 hours from initial puncture is permitted to complete fluid transfer. Discard any unused ULTRAVIST injection 10 hours after initial puncture of the Imaging Bulk Package.

5.

After the container closure is punctured, if the integrity of the Imaging Bulk Package and the delivery system cannot be assured through direct continuous supervision, the Imaging Bulk Package and all associated disposables for the automated contrast injection system, contrast management system, or contrast media transfer set should be discarded.

Storage temperature of Imaging Bulk Package after the closure has been entered should not exceed 25°C (77°F) excursions permitted to 15–30°C (59–86°F); however, it is desirable that the contents be warmed to body temperature prior to injection.