Страна: Канада
Език: английски
Източник: Health Canada
IOXAGLATE SODIUM; IOXAGLATE MEGLUMINE
GUERBET
V08AB03
IOXAGLIC ACID
196MG; 393MG
SOLUTION
IOXAGLATE SODIUM 196MG; IOXAGLATE MEGLUMINE 393MG
INTRAVASCULAR
20/25/30/50/75/100/150/200ML
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0216261001; AHFS:
CANCELLED POST MARKET
2015-07-08
PRODUCT MONOGRAPH PROPRIETARY NAME: Hexabrix® 200 PROPER NAME: Ioxaglate Meglumine 24.6% and Ioxaglate Sodium 12.3% PROPRIETARY NAME: Hexabrix® 320 PROPER NAME: Ioxaglate Meglumine 39.3% and Ioxaglate Sodium 19.6% PHARMACOLOGY CLASSIFICATION: Ionic, low osmolality, water soluble radiopaque contrast medium for intravascular use. GUERBET BP 57400 95943 Roissy CdG Cedex FRANCE Control No. 162948 Revised: April 4, 2013 1 PRODUCT MONOGRAPH NAME OF DRUG HEXABRIX® 200 (Ioxaglate Meglumine 24.6% and Ioxaglate Sodium 12.3%) HEXABRIX® 320 (Ioxaglate Meglumine 39.3% and Ioxaglate Sodium 19.6%) Therapeutic or Pharmacological Classification Ionic, Low Osmolality, Water Soluble, Radiopaque Contrast Medium for Intravascular Use 2 ACTIONS AND CLINICAL PHARMACOLOGY Following intravascular injection, Hexabrix is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine. The pharmacokinetics of intravascularly administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slower beta phase for drug elimination. In patients with normal renal function, the alpha and beta half lives of Hexabrix 320 were 12 and 92 minutes, respectively. Following the intravenous administration of 50 mL of Hexabrix 320 in normal volunteers, the mean peak plasma concentration occurred at two minutes, reaching a concentration of 2.13 mg/mL. Fifty percent of the intravenously administered dose was recovered in the urine at 2 hours, and approximately 90% was recovered at 24 hours. Injectable iodinated contrast agents are excreted either through the kidneys or through the liver. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be related to the affinity of the contrast medium for serum albumin. Ioxaglate salts are poorly bound to serum albumin, and are excreted mainly through the kidneys. The liver and small intestine provide the major alternate route of excretion. Hexabrix appe Прочетете целия документ