OXILAN ioxilan injection solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ioxilan (UNII: A4YJ7J11TG) (ioxilan - UNII:A4YJ7J11TG)

Предлага се от:

Guerbet LLC

INN (Международно Name):

ioxilan

Композиция:

ioxilan 300 mg in 1 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

OXILAN- IOXILAN INJECTION INJECTION, SOLUTION
GUERBET LLC
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OXILAN (IOXILAN INJECTION) 300 MGI/ML
OXILAN (IOXILAN INJECTION) 350 MGI/ML
OXILAN (IOXILAN INJECTION) 300 MGI/ML PHARMACY BULK PACKAGE
OXILAN (IOXILAN INJECTION) 350 MGI/ML PHARMACY BULK PACKAGE
NONIONIC CONTRAST AGENTS
NOT FOR INTRATHECAL USE
PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION
DESCRIPTION
OXILAN® (Ioxilan Injection) formulations are stable, aqueous,
sterile, and non- pyrogenic solutions
for intravascular administration as diagnostic radiopaque media.
Ioxilan is designated chemically as N-
(2,3-dihydroxypropyl)-N’-(2-
hydroxyethyl)-5-[N-(2,3-dihydroxypropyl) acetamido]-2,4,6-
triiodoisophthal-amide and has the following structural formula:
The molecular weight of ioxilan is 791.12 and the organically bound
iodine content is 48.1%. Ioxilan is
nonionic and does not dissociate in solution. OXILAN® (Ioxilan
Injection) Pharmacy Bulk Package is
available in two strengths: OXILAN® (Ioxilan Injection) 300 mgI/mL
and OXILAN® (Ioxilan Injection)
350 mgI/mL.
Each mL of OXILAN® (Ioxilan Injection) 300 mgI/mL provides 623 mg
ioxilan. Each mL of
OXILAN® (Ioxilan Injection) 350 mgI/mL provides 727 mg ioxilan. Each
mL of OXILAN® (Ioxilan
Injection) 300 mgI/mL Pharmacy Bulk Package provides 623 mg ioxilan.
Each mL of OXILAN® (Ioxilan Injection) 350 mgI/mL Pharmacy Bulk
Package provides 727 mg
ioxilan.
Each mL of OXILAN® solution contains 0.1 mg edetate calcium disodium
(anhydrous basis), 1.0 mg
tromethamine, 0.5 mg sodium chloride and a minimum of 0.2 mg (0.01
mEq) sodium. The pH is adjusted
to 6.8 (5.5 to 7.5) with hydrochloric acid and sodium hydroxide. The
solutions contain no preservative.
Pertinent physicochemical data are below. OXILAN® (Ioxilan Injection)
is hypertonic compared to
plasma (approximately 285 mOsm/kg water).
®
®
®
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Concentration (mgI/mL)
Concentration W/V
300
350
Measured Osmolality
(mOsm/kg water)
@ 37°C
610
721
Viscosity (cPs)
@ 37°C
@ 20°C
5.1
9.4
8.1
16.3
Specific Gravity
@ 37°C
@ 20°C
1.319
1.327
1.3