Šalis: Švedija
kalba: švedų
Šaltinis: Läkemedelsverket (Medical Products Agency)
lantan(III)karbonattetrahydrat
Orifarm AB
V03AE03
lanthanum(III)karbonattetrahydrat
750 mg
Tuggtablett
dextrat, hydratiserat Hjälpämne; lantan(III)karbonattetrahydrat 1431 mg Aktiv substans
Apotek
Receptbelagt
Lantankarbonat
Förpacknings: Burk, 90 (6 x 15) tabletter
Avregistrerad
2012-01-11
SUMMARY OF PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Fosrenol 750 mg chewable tablets. 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each chewable tablet contains lanthanum carbonate hydrate corresponding to 750 mg lanthanum. Excipient(s) with known effect Chewable tablets also contain on average 1599 mg of dextrates, containing glucose. For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Chewable tablet. White, round, 20-mm, bevelled-edge flat tablets debossed with ‘S405/750’ on one side. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Fosrenol is indicated in adult patients as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fosrenol is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Where Fosrenol oral powder is available, it can replace chewable tablets in patients who have difficulty chewing the tablets (see section 4.4). _Adults, including elderly (>65 years)_ Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Fosrenol is presented as a chewable tablet therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Fosrenol titrated every 2 to 3 weeks until an acceptable serum phosphate levels is reached, with regular monitoring thereafter. Control of serum phosphate level has been demonstrated at doses starting from 750 mg per day. The maximum dose studied in clinical trials, in a limited number of pati Perskaitykite visą dokumentą