البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
IOVERSOL
TRANSMEDIC PTE LTD
V08AB07
678 mg/ml
INJECTION
INTRAVASCULAR
Prescription Only
Mallinckrodt Inc
1991-09-20
Page 1 of 35 SG-0612 _Based on Montreal Asian PI 10/11 and Raleigh USPI 08/11 _ 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) INOPTH-1011 CONTROL 087416 (INOPT-0709) THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION Non-ionic, low osmolality, water soluble radiopaque contrast medium for intravascular use. Optiray 240 may be used in myelography. 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, exc اقرأ الوثيقة كاملة