国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IRON SUCROSE
COMBIPHAR - Indonesia
IRON SUCROSE
20 MG/ML
CAIRAN INJEKSI
DUS, 5 AMPUL @ 5 ML
IDT BIOLOGIKA GMBH - Germany
2019-05-27
3005174-01 INJECTION _IRON SUCROSE COMPLEX_ COLOURS/FLATS Black PRODUCT Venofer Ampoules COUNTRY Indonesia MANUFACTURER IDT SAP NUMBER 3005174-01 MIN. VER.: 03 MANUFACTURER IDENTIFICATION NUMBER 3030812101 FONTS Univers (min. 8.5 pt) DIMENSIONS 170 x 295 mm NON-PRINTED COLOURS Dye Cut Not printet Color COMPOSITION Each 5 mL ampoule contains 20 mg/mL Iron as Iron Sucrose corresponding to 100 mg Iron per ampoule. MODE OF ACTION PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES The ferrokinetics of Venofer labelled with 59 Fe and 52 Fe were assessed in 5 patients with anaemia and chronic renal failure. Plasma clearance of 52 Fe was in the range of 60 to 100 minutes. 52 Fe was distributed to the liver, spleen and bone marrow. At two weeks after administration, the maximum red blood cell utilisation of 59 Fe ranged from 62% to 97%. PHARMACOKINETIC PROPERTIES Following intravenous injection of a single dose of Venofer con- taining 100 mg Fe (III) in healthy volunteers, maximum iron lev- els, averaging 538 µmol/L, were obtained 10 minutes after injec- tion. The volume of distribution of the central compartment corresponded well to the volume plasma (approx. 3 Litres). The iron injected was rapidly cleared from the plasma, the ter- minal half-life being approx. 6 h. The volume of distribution at steady state was about 8 Litres, indicating a low iron distribu- tion in the body fluid. Due to the lower stability of iron sucrose in comparison to transferrin, a competitive exchange of iron to transferrin was observed. This resulted in iron transport of approx. 31 mg Fe (III) / 24 h. Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than 5% of the total body clearance. After 24 h the plasma levels of iron were reduced to the pre-dose iron level and about 75% of the dosage of sucrose was excreted. PRECLINICAL SAFETY DATA There are no preclinical data of relevance to the prescriber that are additional to information already in other sections of the SPC. INDICATIONS ADULT Venofer is i 阅读完整的文件