OPTIRAY 320 Ioversol 33.9g/50mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ioversol, Quantity: 678 mg/mL (Equivalent: iodine, Qty 320 mg/mL)

Available from:

Guerbet Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide

Administration route:

Intraarterial, Intravenous

Units in package:

25 x 50 mL, 10 x 50 mL

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Indications approved as specified in the letter of 19 April 1993 from Dr H. Arora are as follows: Optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. These include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. Optiray may be used in intravenous excretory urography. Optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1994-07-11

Patient Information leaflet

Page 1 of 6
OPTIRAY® 240
_(Ioversol Injection 51% w/v)_
OPTIRAY® 320
_(Ioversol Injection 68% w/v) _
OPTIRAY® 350
_(Ioversol Injection 74% w/v) _
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):
Page 2 of 6
• 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 planned to be used in your child who is under the age
of two years
TELL YOUR DOCTOR IF:
• you are pregnant, intend to become pregnant or breast-fee

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
OPTIRAY® 240 (IOVERSOL) SOLUTION FOR INJECTION
OPTIRAY® 320 (IOVERSOL) SOLUTION FOR INJECTION
OPTIRAY® 350 (IOVERSOL) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ioversol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OPTIRAY (ioversol injection) formulations are sterile, non-pyrogenic,
aqueous solutions intended for
intravascular administration as diagnostic radiopaque media.
Each millilitre of OPTIRAY 240 (ioversol injection 51% w/v) provides
509 mg of ioversol with 3.6 mg of
trometamol as a buffer and 0.2 mg of sodium calcium edetate as a
stabiliser. OPTIRAY 240 provides 24%
(240 mg/mL) organically bound iodine.
Each millilitre of OPTIRAY 320 (ioversol injection 68% w/v) provides
678 mg of ioversol with 3.6 mg of
trometamol as a buffer and 0.2 mg of sodium calcium edetate as a
stabiliser. OPTIRAY 320 provides 32%
(320 mg/mL) organically bound iodine.
Each millilitre of OPTIRAY 350 (ioversol injection 74% w/v) provides
741 mg of ioversol with 3.6 mg of
trometamol as a buffer and 0.2 mg of sodium calcium edetate as a
stabiliser. OPTIRAY 350 provides 35%
(350 mg/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 240
OPTIRAY 320
OPTIRAY 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°C
4.6
9.9
14.3
at 37°C
3.0
5.8
9.0
Specific gravity at 37°C
1.281
1.371
1.405
For the full list of excipients, see Section 6.1 List of excipients.
2(18)
3
PHARMACEUTICAL FORM
Solution for injection.
The OPTIRAY formulations are clear, colourless to pale yellow
solutions containing no undissolved solids.
Crystallisation does not occur at temperatures above 15°C. The
products are supplied in containers from
which the air has been displaced by nitrogen. OPTIRAY solutions have
osmolalities 1.2 to 2.5 times that
of plasma (285 mOsm/kg wat