Canada - English - Health Canada

takeda canada inc - lanthanum (lanthanum carbonate hydrate) - tablet (chewable) - 1000mg - lanthanum (lanthanum carbonate hydrate) 1000mg - phosphate-removing agents

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lanthanum carbonate hydrate, quantity: 1908 mg - tablet, chewable - excipient ingredients: dextrates; magnesium stearate; silicon dioxide - treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (capd).

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lanthanum carbonate hydrate, quantity: 1431 mg - tablet, chewable - excipient ingredients: dextrates; magnesium stearate; silicon dioxide - treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (capd).

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lanthanum carbonate hydrate, quantity: 954 mg - tablet, chewable - excipient ingredients: dextrates; silicon dioxide; magnesium stearate - treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (capd).

United States - English - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum cation (3+) 500 mg - fosrenol is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (esrd). management of elevated serum phosphorus levels in patients with esrd usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. contraindicated in bowel obstruction, including ileus and fecal impaction. risk summary available data from case reports with use of fosrenol in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (mrhd), resulted in no adverse developmental effects. in rabbits, lanthanum carbonate doses 5 times the mrhd was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see data) . deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a pregnant woman. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus. the mrhd for fosrenol is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m2 for a 60-kg patient. the 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m2 , 3 times the mrhd. in pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m2 ; 5 times the daily mrhd) during organogenesis was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. no effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m2 ; 2.5 times the mrhd). in a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m2 /day; equivalent to 3 times the mrhd) from day 6 of pregnancy through 20 days postpartum (including lactation). at 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day. at 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the mrhd, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see nonclinical toxicology (13.2)] . risk summary there are no data on the presence of lanthanum carbonate from fosrenol in human milk, the effects on the breastfed infant, or the effects on milk production. deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a lactating woman. the safety and efficacy of fosrenol in pediatric patients have not been established. while growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. the consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of fosrenol in this population is not recommended. of the total number of patients in clinical studies of fosrenol, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. no overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.

Israel - English - Ministry of Health

takeda israel ltd - lanthanum as carbonate hydrate - chewable tablets - lanthanum as carbonate hydrate 500 mg - lanthanum carbonate - lanthanum carbonate - fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in crf patients on haemodyalisis or continuous ambulatory peritoneal dialysis (capd).fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels > or = 1.78 mmol/l in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

Israel - English - Ministry of Health

takeda israel ltd - lanthanum as carbonate hydrate - chewable tablets - lanthanum as carbonate hydrate 750 mg - lanthanum carbonate - lanthanum carbonate - fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in crf patients on haemodyalisis or continuous ambulatory peritoneal dialysis (capd).fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels > or = 1.78 mmol/l in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

Israel - English - Ministry of Health

takeda israel ltd - lanthanum as carbonate hydrate - chewable tablets - lanthanum as carbonate hydrate 1000 mg - lanthanum carbonate - lanthanum carbonate - fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in crf patients on haemodyalisis or continuous ambulatory peritoneal dialysis (capd).fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels > or = 1.78 mmol/l in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

Israel - English - Ministry of Health

takeda israel ltd - lanthanum as carbonate hydrate - powder - lanthanum as carbonate hydrate 1000 mg - lanthanum carbonate - fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in crf patients on haemodyalisis 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.

Israel - English - Ministry of Health

takeda israel ltd - lanthanum as carbonate hydrate - powder - lanthanum as carbonate hydrate 750 mg - lanthanum carbonate - fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in crf patients on haemodyalisis 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.