Stati Uniti - inglese - 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

Stati Uniti - inglese - 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

Stati Uniti - inglese - 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.

Stati Uniti - inglese - NLM (National Library of Medicine)

american health packaging - 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 organog

Stati Uniti - inglese - 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

Stati Uniti - inglese - 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

Stati Uniti - inglese - 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.

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

sanofi-aventis australia pty ltd - sevelamer hydrochloride -

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

sanofi-aventis australia pty ltd - sevelamer hydrochloride -

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

sanofi-aventis australia pty ltd - sevelamer hydrochloride -