ISOVUE 300- iopamidol injection, solution ISOVUE 370- iopamidol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44)

Available from:

Bracco Diagnostics Inc

INN (International Name):

IOPAMIDOL

Composition:

IOPAMIDOL 612 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ISOVUE (Iopamidol Injection) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography; or for intravenous use in adult and pediatric for computed tomographic (CT) imaging of the head and body (see below). CT Head Imaging ISOVUE may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Tumors ISOVUE may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the ret

Product summary:

ISOVUE-300 (Iopamidol Injection 61%)    Ten 200 mL Imaging Bulk Packages (NDC 0270-1315-45)    Six 500 mL Imaging Bulk Packages (NDC 0270-1315-95) ISOVUE-370 (Iopamidol Injection 76%)    Ten 200 mL Imaging Bulk Packages (NDC 0270-1316-45)    Six 500 mL Imaging Bulk Packages (NDC 0270-1316-95) Store at 20-25° C (68-77° F). [See USP]. Protect from light. ISOVUE is a registered trademark of Bracco Diagnostics Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

ISOVUE 300- IOPAMIDOL INJECTION, SOLUTION
ISOVUE 370- IOPAMIDOL INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
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ISOVUE
IMAGING BULK PACKAGE
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.
ISOVUE -300
IOPAMIDOL INJECTION 61%
ISOVUE -370
IOPAMIDOL INJECTION 76%
NOT FOR INTRATHECAL USE
ISOVUE 300 and 370 are NOT FOR INTRATHECAL USE.
See Indications, and Dosage and Administration sections for further
details on proper
use
DIAGNOSTIC
NONIONIC RADIOPAQUE CONTRAST MEDIA
For Angiography Throughout the Cardiovascular System in Adults ,
Including Cerebral
and Peripheral Arteriography, Coronary Arteriography and
Ventriculography, Selective
Visceral Arteriography and Aortography, Peripheral Venography
(Phlebography), and in
Pediatric Patients for Angiocardiography;
or
For Intravenous Adult and Pediatric
Computed Tomographic (CT) Imaging of the Head and Body
DESCRIPTION
ISOVUE (Iopamidol Injection) is a stable, aqueous, sterile, and
nonpyrogenic solution for
intravascular administration. Each bottle is to be used as an Imaging
Bulk Package for
dispensing multiple single doses of iopamidol injection for multiple
patients, using 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.
Each mL of ISOVUE-300 (Iopamidol Injection 61%) provides 612 mg
iopamidol with 1 mg
tromethamine and 0.39 mg edetate calcium disodium. The solution
contains
approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound
iodine per
mL.
Each mL of ISOVUE-370 (Iopamidol Injection 76%) provides 755 mg
iopamidol with 1 mg
®
®
®
tromethamine and 0.48 mg edetate calcium disodium. The solution
contains
approximately 0.053 mg (0.002 mEq) sodium and 370 mg organically bound
iodine per
mL.
The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with
hydrochloric ac