Iomeron
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
Iomeprol
Available from:
Bracco Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
PRODUCT INFORMATION
IOMERON
®
300 LOMEPROL INJECTION
IOMERON
®
350 IOMEPROL INJECTION
NAME OF THE MEDICINE
Iomeprol
Chemical name:
N,N’-bis-(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-triiodo-1,3-
benzene-dicarboxamide Iomeprol is a white crystalline powder, which
is highly water soluble.
Organically bound iodine: 49% of its molecular weight.
The chemical structure of Iomeprol is as follows:
CONHCH
2
CHCH
2
OH
I
I
I
CONHCH
2
CHCH
2
OH
OH
CH
3
OH
HOCH
2
CO
-
N
CAS
-
78649-41-9]
MWt
777.09
DESCRIPTION
Iomeron
®
is a sterile aqueous contrast medium solution for intravascular and
body cavities
administration._ _The active ingredient of Iomeron
® formulations is iomeprol, a tri-iodinated, non-
ionic contrast agent, and is indicated for use in X ray
examinations._ _
The Iodine strength-specific physico-chemical characteristics of
Iomeron
® for injection are as
follows:
_Iodine _
_concentration _
_mgI/mL _
_Density§ _
_(g/mL) _
_Osmolality _
_mOsm/kg water _
_ _
_Viscosity _
_mPa.s _
_ _
_ _
_20°C _
_37°C _
_37° C _
_20° C _
_37° C _
300 1.334
1.329
521 8.1 4.5
350 1.390
1.385
618 14.5
7.5
_____________________________________________________________________________
§ = Eur J Radiol Vol 18, suppl 1, 1994: S1-S2.
The pH of the solutions ranges from 6.5-7.2.
The following strengths are available:
IOMERON
_®_
300
Each mL contains iomeprol 612.4 mg, trometamol 1 mg, hydrochloric
acid (d=1.18) 0.24 mg and
water for injections q.s. to 1 mL.
IOMERON
_®_
350
Iomeron
_®_
PI 9
1
of
13
Each mL contains iomeprol 714.4 mg, trometamol 1 mg, hydrochloric
acid (d=1.18) 0.24 mg, and
water for injections q.s. to 1 mL.
PHARMACOLOGY
ANIMAL STUDIES
Results from studies in rats, mice and dogs demonstrate that iomeprol
has an acute intravenous
or intra-arterial toxicity similar to that of the other non-ionic
cont
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