OPTIRAY 160 Ioversol 16.95g/50mL injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

ioversol

Tillgänglig från:

Guerbet Australia Pty Ltd

Bemyndigande status:

Registered

Produktens egenskaper

1
AUSTRALIAN PI
OPTIRAY 160 (IOVERSOL) SOLUTION FOR INJECTION
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 160 (ioversol injection 34%) provides 339
mg of ioversol with 3.6 mg of
trometamol as a buffer and 0.2 mg of sodium calcium edetate as a
stabiliser. OPTIRAY 160 provides
16% (160 mg/mL) organically bound iodine.
Each millilitre of OPTIRAY 240 (ioversol injection 51%) 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%) 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%) 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
3
PHARMACEUTICAL FORM
Solution for injection.
The OPTIRAY formulations are clear, colourless to pale yellow
solutions containing no undissolved
s