title: [The endorem tolerance profile].
abstract: ENDOREM (Guerbet, Sulzbach) is a superparamagnetic contrast agent for magnetic resonance imaging of the liver and spleen. The contrast agent consists of dextran-coated iron oxide particles with a size distribution between 120 and 180 nm and an iron concentration of 0.2 mol/l. Before ENDOREM received approval in Germany and other European countries, clinical trials were performed in Japan, the USA, and Europe. At a dose of 10 micromol Fe/kg (Japan, USA) and 15 micromol Fe/kg (Europe). ENDOREM was slowly infused in 100 ml of glucose 5% over approximately 30 min in 163 (Japan), 213 (USA), and 467 patients (Europe). The rate of side effects ranged between 6.1% (Japan) and 10.3% (Europe). The most frequent side effect was lower back pain. However, infusion was stopped or medication was necessary because of lower back pain in only very few cases. Transient increases of serum iron and ferritin and decreases of iron binding capacity occurred. No clinically relevant changes of heart rate and arterial blood pressure were observed. With the recommended biphasic infusion (2 ml/min over 10 min and 4 ml/min over 20 min) and at a dose of 15 micromol Fe/kg in 100 ml of glucose 5% ENDOREM is a well tolerated contrast agent
authors.affiliation: Abteilung für Radiologische Diagnostik, Eberhard-Karls-Universität, Tübingen.
authors.forename: M
authors.initials: M
authors.lastname: Laniado
authors.forename: A
authors.initials: A
authors.lastname: Chachuat
mesh_terms: D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D003287:Contrast Media / Q000009:adverse effects*; D003911:Dextrans; D003937:Diagnosis, Differential; D004361:Drug Tolerance; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000009:adverse effects*; D008099:Liver / Q000473:pathology; D008107:Liver Diseases / Q000175:diagnosis* / Q000473:pathology; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000473:pathology; D008279:Magnetic Resonance Imaging / Q000379:methods*; D058185:Magnetite Nanoparticles; D010087:Oxides / Q000009:adverse effects*
chemical_list: D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide