Optiray 350 Prefilled Syringe 125ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ioversol

Available from:

TRANSMEDIC PTE LTD

Dosage:

741 mg/ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Ioversol 741 mg/ml

Administration route:

INTRAVASCULAR

Prescription type:

Prescription Only

Manufactured by:

Liebel-Flarsheim Company LLC

Authorization status:

ACTIVE

Authorization date:

2008-09-10

Patient Information leaflet

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, 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, 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 pl

Summary of Product characteristics

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, 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.
Page 1 of 36
SG-0612
_Based on Montreal Asian PI 10/11 and Raleigh USPI 08/11_
_Last revised: Jun 2020_
Optiray, like other non-ionic contrast media, has an insignificant
effect on blood
coag