Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Iomeprol
Bracco Pty Ltd
Medicine Registered
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 Soma hati kamili