Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IOPROMIDE
BAYER INDONESIA - Indonesia
IOPROMIDE
370 MGI/ML
INFUS
DUS, 10 BOTOL @ 100 ML
BAYER AG., - GERMANY
2018-05-23
Name of Product/Active ingredient/Dosage form/Version/Date of approval ULTRAVIST 300 & 370/Iopromide/Solution for injection/BEC 19581 & 19924 - CCDS #15&16/ 1 ULTRAVIST ® 300 / 370 SOLUTION FOR INJECTION/INFUSION Important information, please read carefully! COMPOSITION Ultravist 300: 1 ml contains 623 mg iopromide (equivalent to 300 mg iodine) Ultravist 370: 1 ml contains 769 mg iopromide (equivalent to 370 mg iodine) PHARMACEUTICAL FORM Solution for injection/infusion. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar X-ray contrast media ATC code: V08AB05 The contrast-giving substance in the Ultravist formulations is iopromide, a non-ionic, water-soluble derivative of triiodi nated isophthalic acid with a molecular weight of 791.12 in which the firmly bound iodine absorbs the X-rays. Injection of iopromide opacifies those vessels or body cavities in the path of flow of the contrast ag en t, p ermi tti n g rad i o- graphic visualization of the internal structures until significant dilution occurs. PHARMACOKINETIC PROPERTIES GENERAL INFORMATION Iopromide behaves in the organism like other highly hydrophilic biologically inert, renally excreted compounds (e.g. mannitol or inulin). ABSORPTION AND DISTRIBUTION Following intravenous administration, plasma concentrations of iopromide decline rapidly due to distribution into the extracellular space and subsequent elimination. The total distribution volume at steady state is about 16 L corresponding roughly to the volume of the extracellular space. Protein binding is negligible (about 1%). There is no indication that iopromide crosses the intact blood-brain-barrier. A smal l amount crossed the placental barrier in animal studies (≤ 0.3 % of the dose were found in rabbit fetuses). Following intrathecal administration, maximum iodine concentrations of 4.5 % of the administered dose per total plasma volume were observed after 3.8 hours. Following administration in the biliary and/or pancreatic duct Preberite celoten dokument