Optiray

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

Ioversol

থেকে পাওয়া:

Mallinckrodt Australia Pty Ltd

শ্রেণী:

Medicine Registered

তথ্য লিফলেট

ISSUE DATE: April 2010
OPTIRAY
™
 240
_(Ioversol Injection 51% W/V)_
OPTIRAY
™
 320
_(Ioversol Injection 68% W/V)_
OPTIRAY
™
 350
_(Ioversol Injection 74% W/V)_
Mallinckrodt Inc.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common 
questions about Optiray.  It does 
not contain all the available 
information. It does not take the 
place of talking to your doctor.
All medicines have risks and 
benefits.  Your doctor has 
weighed the risks of using Optiray 
against the benefits it is expected 
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT 
RECEIVING OPTIRAY, ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
IN THIS LEAFLET:
1.  What  is Optiray  and what it 
is used for
2.  Before you are given Optiray 
3.  How Optiray is given
4.  When you are given Optiray
5.  Possible side effects
6. Product Description
1. WHAT IS OPTIRAY AND 
WHAT IT IS USED FOR
Optiray is an injectable contrast 
medium.  It is used to make 
clearer diagnostic images of the 
brain and body in adults and 
children.  As a result, it helps to 
clearly show abnormalities in the 
brain or body.  This medicine is for 
diagnostic use only.
2. BEFORE YOU ARE GIVEN 
OPTIRAY
_WHEN YOU MUST NOT USE IT_
Do not use Optiray if you are 
allergic (hypersensitive):
•  to the active substance ioversol, 
or
•  to any of the other ingredients 
in Optiray
_TAKE SPECIAL CARE WITH OPTIRAY_
Diagnostic procedures involving 
the use of contrast agents should 
be conducted under supervision of 
a physician with the prerequisite 
training and a thorough 
knowledge of the procedure to be 
performed.  
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF:
•  you suffer from allergies (e.g. 
medicinal products, seafood, 
hay fever, hives) or asthma
•  you had any reaction to 
previous injections of a contrast 
agent, including a previous 
history of reaction to iodine-
based agents
•  your kidneys do not function 
properly
•  Optiray is

পণ্য বৈশিষ্ট্য

PRODUCT INFORMATION
Name of Medicine
INOPTAU-0410 CA: 
87771-40-2
DESCRIPTION
Optiray™ (loversol Injection) formulations are sterile, 
nonpyrogenic, aqueous solutions intended for intravascular 
administration as diagnostic radiopaque media. Ioversol is 
designated chemically as N, N’-bis (2, 3-dihydroxypropyl)-
5-[N-(2-hydroxyethyl)glycollamido]-2, 4, 6-triiodoisopthalamide 
and has the following structural formula:
CAS number for Ioversol: 87771-40-2
The molecular weight of ioversol is 807.13 and the organically 
bound iodine content is 47.2%. Ioversol is non ionic and does 
not dissociate in solution.
Each millilitre of Optiray™-240 (ioversol injection 51%) provides 
509mg of ioversol with 3.6mg of TROMETAMOL as a buffer and 
0.2mg of sodium calciumedetate as a stabiliser. Optiray™-240 
provides 24% (240mg/mL) organically bound iodine.
Each millilitre of Optiray™-320 (ioversol injection 68%) provides 
678mg of ioversol with 3.6mg of TROMETAMOL as a buffer and 
0.2mg of sodium calciumedetate as a stabiliser. Optiray™-320 
provides 32% (320mg/mL) organically bound iodine.
Each millilitre of Optiray™-350 (ioversol injection 74%) provides 
741mg of ioversol with 3.6mg of TROMETAMOL as a buffer and 
0.2mg of sodium calciumedetate as a stabiliser. Optiray™-350 
provides 35% (350mg/mL) organically bound iodine.
The pH of the Optiray™ formulations has been adjusted to 
6.0 to 7.4 with hydrochloric acid or sodium hydroxide.
Some physical and chemical properties of these formulations 
are listed below:

OPTIRAY OPTIRAY OPTIRAY
 240 
320 
350
Ioversol content (mg/mL) 
509 
678 
741
Iodine content (mg/mL) 
240 
320 
350
Osmolality (mOsm/kg water) 
502 
702 
792
Viscosity (cps)
    at 25 celsius 
4.6 
9.9 
14.3
    at 37 celsius 
3.0 
5.8 
9.0
Specific gravity at 37 celsius 
1.281 
1.371 
1.405
The Optiray formulations are clear, colourless to pale yellow 
solutions containing no undissolved solids. Crystallization 
does not occur at temperatures above 15°