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

remedyrepack inc. - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (ckd) on dialysis. pediatric use information is approved for genzyme corporation’s renvela (sevelamer carbonate) tablets and renvela (sevelamer carbonate) for oral suspension. however, due to genzyme corporation’s marketing exclusivity rights, these drug products are not labeled with that pediatric information. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology

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

dr reddys laboratories australia pty ltd - sevelamer carbonate, quantity: 800 mg - tablet, film coated - excipient ingredients: silicon dioxide; hyprolose; crospovidone; 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 lupin is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

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

american health packaging - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)]. consider supplementation. 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

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

aurobindo pharma limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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 in mid and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). in pregnant rabbits given oral doses of 100, 500, or 1,000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose). risk summary sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. the safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with ckd. in this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with ckd. most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. no new risks or safety signals were identified with the use of sevelamer carbonate in the trial. sevelamer carbonate has not been studied in pediatric patients below 6 years of age. clinical studies of sevelamer carbonate 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.

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

aurobindo pharma limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate for oral suspension is contraindicated in patients with bowel obstruction. sevelamer carbonate for oral suspension is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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 in mid and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). 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 twice the maximum clinical trial dose). risk summary sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. the safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with ckd. in this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with ckd. most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. no new risks or safety signals were identified with the use of sevelamer carbonate in the trial. sevelamer carbonate has not been studied in pediatric patients below 6 years of age. clinical studies of sevelamer carbonate 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.

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

dr. reddy's laboratories limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis.  sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology ( 12.2 )] . consider supplementation.   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 vitami

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

winthrop u.s, a business of sanofi-aventis u.s. llc - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate is contraindicated in patients with bowel obstruction. sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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 in mid and high-dose groups (human equivalent doses approximately equal to 3–4 times the maximum clinical trial dose of 13 g). 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 twice the maximum clinical trial dose). risk summary sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. clinical considerations sevelamer carbonate may decrease serum levels of fat-soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. the safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with ckd. in this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with ckd. most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. no new risks or safety signals were identified with the use of sevelamer carbonate in the trial. sevelamer carbonate has not been studied in pediatric patients below 6 years of age. clinical studies of sevelamer carbonate 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.

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

micro labs limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablet is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. 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

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

remedyrepack inc. - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (ckd) on dialysis. pediatric use information is approved for genzyme corporation’s renvela (sevelamer carbonate) tablets and renvela (sevelamer carbonate) for oral suspension. however, due to genzyme corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider suppleme

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

impax generics - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (ckd) on dialysis. pediatric use information is approved for genzyme corporation’s renvela (sevelamer carbonate) tablets and renvela (sevelamer carbonate) for oral suspension. however, due to genzyme corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplemen