Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ioxilan (UNII: A4YJ7J11TG) (ioxilan - UNII:A4YJ7J11TG)
Guerbet LLC
ioxilan
ioxilan 300 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
OXILAN- IOXILAN INJECTION INJECTION, SOLUTION GUERBET LLC ---------- 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). ® ® ® ® 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 Izlasiet visu dokumentu