OPTIRAY 300 INJECTION 64%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IOVERSOL EQV BOUND IODINE

Available from:

TRANSMEDIC PTE LTD

ATC code:

V08AB07

Dosage:

64.00%

Pharmaceutical form:

INJECTION

Administration route:

INTRAVASCULAR

Prescription type:

Prescription Only

Manufactured by:

MALLINCKRODT CANADA ULC

Authorization date:

1998-09-17

Patient Information leaflet

INOPTH-0113
(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, excretion does not occur.
Optiray does not notably bind to serum or plasma proteins to any
marked extent and no 
significant metabolism, deiodination 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, like other non-ionic contrast media, has an insignificant
effect on blood coagulation (as 
shown by slightly increased prothrombin time and partial
thromboplastin time, and delayed 
platelet aggregation) and does not possess the anti-coagulant
properties of ionic contrast media.
Optiray causes concentration-dependent hemolysis, aggregation and
crenation of red b