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

sanofi-aventis australia pty ltd - sevelamer carbonate -

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

genzyme corporation - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - renvela ® (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. renvela is contraindicated in patients with bowel obstruction. renvela 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

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

atlantic biologicals corps - 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, these drug products are not labeled with that pediatric information. sevelamer carbonate is 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

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

unit dose services - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate is 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. however, due to genzyme corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information 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/

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

dr. reddys laboratories inc - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - 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 reduc

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

hangzhou anprime biopharm co., ltd. - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - 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-do

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

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

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - sevelamer carbonate - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Ireland - English - HPRA (Health Products Regulatory Authority)

genthon b.v. - sevelamer carbonate anhydrous - film-coated tablet - 800 milligram(s) - drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

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; crospovidone; hyprolose; 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-drla is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.