ISOVUE 250- iopamidol injection, solution ISOVUE 300- iopamidol injection, solution ISOVUE 370- iopamidol injection, solutio

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

BIPSO GmbH

Spôsob podávania:

INTRAVASCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

ISOVUE (Iopamidol 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. None.

Prehľad produktov:

ISOVUE-250 (Iopamidol Injection 51%) Ten 200 mL Pharmacy Bulk Packages (NDC 0270-1317-41) ISOVUE-300 (Iopamidol Injection 61%) Ten 200 mL Pharmacy Bulk Packages (NDC 0270-1315-41) Six 500 mL Pharmacy Bulk Packages (NDC 0270-1315-98) ISOVUE-370 (Iopamidol Injection 76%) Ten 200 mL Pharmacy Bulk Packages (NDC 0270-1316-41) Six 500 mL Pharmacy Bulk Packages (NDC 0270-1316-98) Store at 20-25° C (68-77° F). [See USP]. Protect from light.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

ISOVUE 250- IOPAMIDOL INJECTION, SOLUTION
ISOVUE 300- IOPAMIDOL INJECTION, SOLUTION
ISOVUE 370- IOPAMIDOL INJECTION, SOLUTION
BIPSO GMBH
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IS OVUE
PHARMACY BULK PACKAGE-
NOT FOR DIRECT INFUSION
ISOVUE -250
IOPAMIDOL INJECTION 51%
ISOVUE -300
IOPAMIDOL INJECTION 61%
ISOVUE -370
IOPAMIDOL INJECTION 76%
NOT FOR INTRATHECAL USE
ISOVUE 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
DESCRIPTION
ISOVUE (Iopamidol Injection) formulations are stable, aqueous,
sterile, and nonpyrogenic solutions for
intravascular administration. Each bottle is to be used as a Pharmacy
Bulk Package for dispensing
multiple single dose preparations utilizing a suitable transfer
device.
Each mL of ISOVUE-250 (Iopamidol 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.
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 acid and/or sodium
hydroxide. Pertinent physicochemical data are noted below. ISOVUE
(Iopamidol Injection) is