Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, 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 reduced abso

Združene države Amerike - angleščina - NLM (National Library of Medicine)

bora pharmaceutical laboratories inc. - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - 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 3-4 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 tablets are not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate tablets. 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 tablets 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.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

northstar rxllc - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals 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

Združene države Amerike - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sevelamer carbonate -

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sevelamer carbonate -

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sevelamer carbonate -

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

golden state medical supply - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - 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 f