Land: Canada
Språk: engelsk
Kilde: Health Canada
IOHEXOL
GE HEALTHCARE CANADA INC
V08AB02
IOHEXOL
388MG
SOLUTION
IOHEXOL 388MG
SUBARACHNOIDAL
20ML VIAL
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0116846002; AHFS:
CANCELLED POST MARKET
2023-02-21
PRODUCT MONOGRAPH OMNIPAQUE (iohexol injection USP) OMNIPAQUE 180 (iohexol injection USP 39% w/v, 180 mg I/mL) OMNIPAQUE 240 (iohexol injection USP 52% w/v, 240 mg I/mL) OMNIPAQUE 300 (iohexol injection USP 65% w/v, 300 mg I/mL) OMNIPAQUE 350 (iohexol injection USP 76% w/v, 350 mg I/mL) Non-ionic radiographic contrast medium GE Healthcare Canada Inc. Date of Revision: 1919 Minnesota Court, Mississauga, Ontario January 12, 2021 L5N 0C9 Control Number: 242219 2 NAME OF DRUG OMNIPAQUE (iohexol injection USP) OMNIPAQUE 180 ( iohexol injection USP, 39% w/v, 180 mg I/mL ) OMNIPAQUE 240 ( iohexol injection USP, 52% w/v, 240 mg I/mL) OMNIPAQUE 300 ( iohexol injection USP, 65% w/v, 300 mg I/mL ) OMNIPAQUE 350 ( iohexol injection USP, 76% w/v, 350 mg I/mL ) THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION Non-ionic radiographic contrast medium. ACTION AND CLINICAL PHARMACOLOGY A. GENERAL Immediately following rapid intravascular injection, Omnipaque (iohexol) reaches peak plasma concentration and is then rapidly distributed throughout the extracellular fluid 3 compartment. Iohexol does not normally cross the blood-brain barrier to any significant extent. It is excreted unchanged by the kidneys, mainly by glomerular filtration; tubular secretion plays a minor role, and a very small quantity (1-2%) is excreted via the bile. About 80-90% of the injected dose is excreted in the first 24 hours, with peak urine concentrations occurring in the first hour. Pharmacokinetic studies of iohexol following i.v. injection in healthy male volunteers showed, using a three-compartment open model, that its distribution half-life (alpha phase) is 22 minutes, excretion half-life (beta phase) 2.1 hours, and first-order terminal elimination half-life (gamma phase) 12.6 hours. The volume of distribution of the central compartment is 165-270 mL/kg, the mean renal clearance 120 mL/min., and the mean total body clearance is 131 mL/min. In the presence of impaired renal function, the excretion of iohexol by the kidneys will b Les hele dokumentet