IOPAMIRO 300

Valsts: Indonēzija

Valoda: indonēziešu

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

Aktīvā sastāvdaļa:

IOPAMIDOL

Pieejams no:

DIPA PHARMALAB INTERSAINS

SNN (starptautisko nepatentēto nosaukumu):

IOPAMIDOL

Deva:

300 MG I/ML

Zāļu forma:

CAIRAN INJEKSI

Vienības iepakojumā:

DUS, 1 BOTOL @ 100 ML

Ražojis:

PATHEON ITALIA S.P.A - Italy

Autorizācija datums:

2018-12-14

Produkta apraksts

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:
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
tolerability of Iopamiro®. The
favourable results of extended biological and clinical investigations
confirm the suitability of Iopamiro® as a
contrast medium for intrathecal, intra-arterial and intravenous
administration.
GENERAL INDICATIONS
_NEURORADIOLOGY: _myeloradiculography, cisternography and
ventriculography. _ANGIOGRAPHY: _cerebral
arteriography, coronary arteriography, thoracic aortography, abdominal
aortography, angiocardiography,
selective visceral arteriography, peripheral arteriography,
venography, digital subtraction angiography
(DSA), DSA of cerebral arteries, DSA of