ISOVUE 300- iopamidol injection, solution ISOVUE 370- iopamidol injection, solution ISOVUE 200- 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

Administration route:

INTRAVASCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ISOVUE (lopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging (see below). ISOVUE may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. 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 r

Product summary:

ISOVUE-200 (lopamidol Injection 41%)    Ten 200 mL single dose bottles (NDC 0270-1314-15) ISOVUE-250 (lopamidol Injection 51%)    Ten 100 mL single dose bottles (NDC 0270-1317-02) ISOVUE-300 (lopamidol Injection 61%)    Ten 30 mL single dose vials (NDC 0270-1315-25)    Ten 50 mL single dose vials (NDC 0270-1315-30)    Ten 100 mL single dose bottles (NDC 0270-1315-35)    Ten 150 mL single dose bottles (NDC 0270-1315-50) ISOVUE-370 (lopamidol Injection 76%)    Ten 50 mL single dose vials (NDC 0270-1316-30)    Ten 75 mL single dose bottles (NDC 0270-1316-52)    Ten 100 mL single dose bottles (NDC 0270-1316-35)    Ten 125 mL single dose bottles (NDC 0270-1316-04)    Ten 150 mL single dose bottles (NDC 0270-1316-37)    Store at 20-25° C (68-77° F). [See USP]. Protect from light. lopamidol Injection is also available as ISOVUE-M® for intrathecal administration. 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
ISOVUE 200- IOPAMIDOL INJECTION, SOLUTION
ISOVUE 250- IOPAMIDOL INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
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ISOVUE -200
IOPAMIDOL INJECTION 41%
ISOVUE -250
IOPAMIDOL INJECTION 51%
ISOVUE -300
IOPAMIDOL INJECTION 61%
ISOVUE -370
IOPAMIDOL INJECTION 76%
NOT FOR INTRATHECAL USE
ISOVUE 200, 250, 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, Including Cerebral and Peripheral Arteriography,
Coronary Arteriography and Ventriculography,
Pediatric Angiocardiography, Selective Visceral
Arteriography and Aortography,
Peripheral Venography (Phlebography), and
Adult and Pediatric Intravenous Excretory
Urography and Intravenous Adult and Pediatric
Contrast Enhancement of Computed Tomographic
(CECT) Head and Body Imaging
DESCRIPTION
ISOVUE (lopamidol Injection) formulations are stable, aqueous,
sterile, and nonpyrogenic
solutions for intravascular administration.
Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg
iopamidol with 1 mg
tromethamine and 0.26 mg edetate calcium disodium. The solution
contains
approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound
iodine per
mL.
Each mL of ISOVUE-250 (lopamidol Injection 51%) provides 510 mg
iopamidol with 1 mg
tromethamine and 0. 33 mg edetate calcium disodium. The solution
contains
approximately 0.036 mg (0.002 mEq) sodium and 250 mg organically bound
iodine per
mL.
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®
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Each mL of ISOVUE-300 (lopamidol 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 (lopamidol Injection 76%) provides 755 mg
iopamidol with 1 mg
tromethamine and 0.48 mg edetate calcium disodium. The solution
contains
approxima