OPTIRAY 350 INJECTION 74%

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

IOVERSOL

Հասանելի է:

TRANSMEDIC PTE LTD

ATC կոդը:

V08AB07

Դոզան:

741 mg/ml

Դեղագործական ձեւ:

INJECTION

Կազմը:

IOVERSOL 741 mg/ml

Կառավարման երթուղին:

INTRAVASCULAR

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Liebel-Flarsheim Company LLC

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

1994-06-15

Տեղեկատվական թերթիկ

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

Ապրանքի հատկությունները

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