Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
Iron sucrose
Baxter Healthcare Pty Ltd
Medicine Listed (Export Only)
VIFOR (INTERNATIONAL) INC. PRODUCT INFORMATION VENOFER NAME OF THE MEDICINE VENOFER ® (iron sucrose). VENOFER solution contains a mixture of polymers, each consisting of a polynuclear iron(III) hydroxide core superficially surrounded by a larger number of non-covalently bound sucrose molecules. The proposed molecular formula is: [Na 2 Fe 5 O 8 (OH)·3(H 2 O)] n ·m(C 12 H 22 O 11 ) where n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron(III)-hydroxide. CAS Number: 8047-67-4 (saccharated iron oxide). Molecular weight range: 34000–60000. Nominal amount of sucrose: 320 g/L DESCRIPTION Solution for intravenous use. Each VENOFER 5 mL ampoule contains 20 mg/mL iron as iron sucrose (iron(III) hydroxide sucrose complex) as the active ingredient corresponding to 100 mg iron per 5 mL ampoule. Inactive ingredients include water for injections and sodium hydroxide. It has a pH of 10.5– 11.0 and an osmolarity of 1250 mOsmol/L. PHARMACOLOGY Pharmacokinetics: In healthy adults treated with intravenous doses of VENOFER, its iron component exhibits first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, non-steady state apparent volume of distribution of 10.0 L and steady state apparent volume of distribution of 7.9 L. Since iron disappearance from serum depends on the need for iron in the iron stores and iron utilising tissues of the body, serum clearance of iron is expected to be more rapid in iron deficient patients treated with VENOFER as compared to healthy individuals. The effects of age and gender on the pharmacokinetics of VENOFER have not been studied. The iron sucrose complex is not dialyzable through CA 210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In _in Baca dokumen lengkapnya