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

prasco laboratories - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum cation (3+) 500 mg - lanthanum carbonate 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 lanthanum carbonate 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 lanthanum carbonate 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 lanthanum carbonate 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 lanthanum carbonate 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 lanthanum carbonate in this population is not recommended. of the total number of patients in clinical studies of lanthanum carbonate, 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.

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

lupin pharmaceuticals, inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum cation (3+) 500 mg - lanthanum carbonate chewable tablet 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablet 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets in this population is not recommended. of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 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.

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

teva pharmaceuticals usa, inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum carbonate chewable tablets are 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets in this population is not recommended. of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 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.

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

exelan pharmaceuticals, inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum carbonate chewable tablets are 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 lanthanum carbonate 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

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

cipla usa inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum carbonate chewable tablets are 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 lanthanum carbonate 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

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

piramal pharma limited - halothane - liquid for inhalation - 100%

New Zealand - English - Ministry for Primary Industries

biovax limited - halothane - halothane 999.9 g/litre - anaesthetic

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lanthanum - chewable tablet - lanthanum 750 mg - all other therapeutic products

Canada - English - Health Canada

natco pharma (canada) inc - lanthanum (lanthanum carbonate dihydrate) - tablet (chewable) - 250mg - lanthanum (lanthanum carbonate dihydrate) 250mg - phosphate-removing agents

Canada - English - Health Canada

natco pharma (canada) inc - lanthanum (lanthanum carbonate dihydrate) - tablet (chewable) - 500mg - lanthanum (lanthanum carbonate dihydrate) 500mg - phosphate-removing agents