Spojené státy - angličtina - 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

Spojené státy - angličtina - NLM (National Library of Medicine)

genzyme corporation - sevelamer hydrochloride (unii: gls2pgi8qg) (sevelamer - unii:941n5duu5c) - sevelamer hydrochloride 400 mg - renagel ® is indicated for the control of serum phosphorus in patients with chronic kidney disease (ckd) on dialysis. the safety and efficacy of renagel in ckd patients who are not on dialysis have not been studied. renagel is contraindicated in patients with bowel obstruction. renagel 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 renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vit

Panama - angličtina - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

sandoz gmbh - sevelamero carbonato anhidro - sevelamero carbonato anhidro....800.00 mg

Panama - angličtina - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

genthon b.v. - sevelamero carbonato anhidro - sevelamero carbonato anhidro....800.00 mg

Panama - angličtina - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

genthon b.v. - sevelamero carbonato anhidro - sevelamero carbonato anhidro....800.00 mg.

Izrael - angličtina - 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.

Izrael - angličtina - 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sevelamer hydrochloride, quantity: 800 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; stearic acid; hypromellose; acetylated monoglycerides; propylene glycol; isopropyl alcohol; purified water; iron oxide black - renagel is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

Panama - angličtina - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

inversiones tagore panama, s.a. (tagore) - sevelamer carbonato - sevelamer carbonato....800,00 mg

Spojené státy - angličtina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - 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 tablet is contraindicated in patients with bowel obstruction.   sevelamer carbonate tablet 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.