Land: Canada
Taal: Engels
Bron: Health Canada
IOVERSOL
TYCO HEALTHCARE
V08AB07
IOVERSOL
34%
SOLUTION
IOVERSOL 34%
INTRAVASCULAR
100
Ethical
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0131317004; AHFS:
CANCELLED PRE MARKET
2010-03-12
PRESCRIBING INFORMATION PROPRIETARY NAME: OPTIRAY 160, 240, 300, 320, 350 PROPER NAME: Ioversol Injection 34%, Ioversol Injection 51%, Ioversol Injection 64%, Ioversol Injection 68%, Ioversol Injection 74% PHARMACOLOGY CLASSIFICATION: Non-ionic, low osmolality, water soluble, radiopaque contrast medium for intravascular use. tyco Healthcare 7500 Trans Canada Highway Montreal, Quebec H9R 5H8 CANADA Revised: March 10, 2004 NC Control No: 087416 _Page 2_ PRODUCT MONOGRAPH OPTIRAY (Ioversol Injection) OPTIRAY 160 (Ioversol Injection 34%, 160 mgI/mL) OPTIRAY 240 (Ioversol Injection 51%, 240 mgI/mL) OPTIRAY 300 (Ioversol Injection 64%, 300 mgI/mL) OPTIRAY 320 (Ioversol Injection 68%, 320 mgI/mL) OPTIRAY 350 (Ioversol Injection 74%, 350 mgI/mL) THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION Non-ionic, low osmolality, water soluble radiopaque contrast medium for intravascular use. Optiray 240 may be used in myelography. _Page 3_ ACTIONS AND CLINICAL PHARMACOLOGY A. GENERAL The pharmacokinetics of Optiray (ioversol) in normal subjects conform to an open two compartment model with first order elimination (a rapid alpha phase of 6.8 minutes for drug distribution and a slower beta phase of 92 minutes, for drug elimination). Based on the blood clearance curves for 12 healthy volunteers (6 receiving 50 mL and 6 receiving 150 mL of Optiray 320), the biological half-life was 1.5 hours for both dose levels and there was no evidence of any dose related difference in the rate of elimination. The mean half-life for urinary excretion following a 50 mL dose was 118 minutes (105-156) and following a 150 mL dose was 105 minutes. Optiray is excreted mainly through the kidneys following intravascular administration. Fecal elimination is 3-9%. Approximately 50% of the injected dose is excreted at 1.5 hours and 86% at 48 hours; about 1.5% is retained, mostly by the thyroid and liver. In patients with impaired renal function and in infants with immature kidneys, the elimination half-life is prolonged. In patients with severe renal disease, ex Lees het volledige document