Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
IOVERSOL
TRANSMEDIC PTE LTD
V08AB07
741 mg/ml
INJECTION
IOVERSOL 741 mg/ml
INTRAVASCULAR
Prescription Only
Liebel-Flarsheim Company LLC
ACTIVE
1994-06-15
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 Citiți documentul complet
Page 1 SG-0422 _Based on Montreal Asian PI 10/11 and Raleigh _ _USPI 08/11 _ Optiray 240 may be used in myelography. INOPTH-1011 CONTROL 087416 (INOPT-0709) THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION Non-ionic, low osmolality, water soluble radiopaque contrast medium for intravascular use. 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, excretion does not occur. Optiray does not notably bind to serum or plasma proteins to any marked extent and no significant metabolism, deionization or biotransformation occurs. OPTIRAY, LIKE ALL OTHER CONTRAST MEDIA, MAY INDUCE CHANGES IN THYROID FUNCTION IN SOME PATIENTS, AND ELEVATION OF THYROXINE AND/OR TSH MAY BE OBSERVED. 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) Page 2 SG-0422 _Based on Montreal Asian PI 10/11 and Raleigh _ _USPI 08/11 _ Optiray, like other non-ionic contra Citiți documentul complet