Malaysia - Inggris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - sevelamer carbonate -

Israel - Inggris - Ministry of Health

sanofi israel ltd - sevelamer carbonate anhydrous - film coated tablets - sevelamer carbonate anhydrous 800 mg - sevelamer - sevelamer - for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Israel - Inggris - Ministry of Health

sanofi israel ltd - sevelamer carbonate anhydrous - powder for suspension - sevelamer carbonate anhydrous 2.4 g/sachet - sevelamer - sevelamer - for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.also indicated for the control of hyperphosphataemia in adult patients with chronic kidney diseasenot on dialysis with serum phosphorus ≥ 1.78 mmol/l.should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - sevelamer carbonate - powder - 2.4gram

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

dr reddys laboratories australia pty ltd - sevelamer carbonate, quantity: 800 mg - tablet, film coated - excipient ingredients: crospovidone; hyprolose; silicon dioxide; mannitol; zinc stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified talc; xanthan gum; polyvinyl alcohol; lecithin - sevelamer-reddy?s is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of sevelamer hydrochloride tablets in ckd patients who are not on dialysis have not been studied. sevelamer hydrochloride is contraindicated in patients with bowel obstruction. sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. risk summary sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [ see clinical pharmacology (12.2)] . consider supplementing with these vitamins. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred at 7-21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. in pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurredin the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight). risk summary sevelamer hydrochloride is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to sevelamer hydrochloride. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in lactating women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. the safety and efficacy of sevelamer hydrochloride has not been established in pediatric patients. clinical studies of sevelamer hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

aurobindo pharma limited - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of sevelamer hydrochloride tablets in ckd patients who are not on dialysis have not been studied. sevelamer hydrochloride tablets are contraindicated in patients with bowel obstruction. sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. risk summary sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred at 7 to 21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. in pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight).   risk summary sevelamer hydrochloride is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to sevelamer hydrochloride. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in lactating women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. the safety and efficacy of sevelamer hydrochloride has not been established in pediatric patients. clinical studies of sevelamer hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

winthrop u.s, a business of sanofi-aventis u.s. llc - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride is indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of sevelamer hydrochloride in ckd patients who are not on dialysis have not been studied. sevelamer hydrochloride is contraindicated in patients with bowel obstruction. sevelamer hydrochloride is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. risk summary sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer hydrochloride may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bon

Amerika Serikat - Inggris - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of sevelamer hydrochloride tablets in ckd patients who are not on dialysis have not been studied. sevelamer hydrochloride is contraindicated in patients with bowel obstruction. sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. risk summary sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementing with these vitamins. data animal data: in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregula

Amerika Serikat - Inggris - NLM (National Library of Medicine)

carilion materials management - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. renvela is contraindicated in patients with bowel obstruction. renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate or to any of the excipients. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. sevelamer products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of sevelamer hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. in pregnant rats given doses of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred at a dose approximately equal to the maximum clinical trial dose of 13 g on a body su