IOPAMIRO 370

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

IOPAMIDOL

Saadav alates:

DIPA PHARMALAB INTERSAINS - Indonesia

INN (Rahvusvaheline Nimetus):

IOPAMIDOL

Annus:

755.3 MG

Ravimvorm:

INJEKSI

Ühikuid pakis:

DUS, 1 VIAL @ 50 ML

Valmistatud:

PATHEON ITALIA S.P.A - Italy

Loa andmise kuupäev:

2021-06-17

Toote omadused

_SENSO MACCHINA LETTURA CODICE_
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The product Iopamiro
®
(lopamidol) was discovered and developed in the research laboratories
of Bracco s.p.a.
of Milan (Italy). Chemically the substance is: (S)-N,N’-bis
[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-
5-lactamido-isophthalamide.
Iopamiro
®
is a x-ray contrast medium of the new generation of non ionic
compounds, which are water soluble
because the molecular structure incorporates hydrophilic groups. This
new class of contrast media differs
significantly from other compounds currently used in connection with
radiological procedures, all of which are
soluble only when the radiopaque molecule is ionised by forming a salt
with sodium and/or meglumine. While
such products are remarkably well tolerated, their aqueous solutions
show an inherently high osmolality and this
is responsible for a number of side effects that may occur after
administration. The discovery of non ionic
contrast agents has afforded, along with a sizable reduction of
general toxicity, a considerable improvement in
local and tissue tolerability, even by the more delicate structures of
the human body such as vascular endothelia
and the central nervous system. The product is available as
preconstituted solution in four different
concentrations, with the following physical properties:
_Concentration _
_Viscosity mPa.s _
_Relative density d_
_20_
_4_
_ _
_Osmometric values at 37°C _
_ mg iodine/ml g iopamidol/100ml _
_20°C _
_37°C _
_20°C _
_ Osmolality _
_Osmotic _
_ _
_pH_
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ (osmol.kg_
_-1_
_) _
_pressure (atm)_
150
30.6
2.3
1.5
1.17
0.342
8.7
7 ± 0.5
200
40.8
3.3
2.0
1.22
0.413
10.5
7 ± 0.5
300
61.2
8.8
4.7
1.33
0.616
15.7
7 ± 0.5
370
75.5
20.9
9.4
1.41
0.796
20.3
7 ± 0.5
The low osmotic pressure of solutions, the nonionic nature of the
molecule and its inherently low chemotoxicity
contribute to the exceptionally good local and systemic tolerabili