Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IOPAMIDOL
DIPA PHARMALAB INTERSAINS - Indonesia
IOPAMIDOL
612.4 MG
INJEKSI
DUS, 1 BOTOL @ 100 ML
PATHEON ITALIA S.P.A - Italy
2021-06-17
_SENSO MACCHINA LETTURA CODICE_ 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 0 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 Lugege kogu dokumenti