New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - sevelamer carbonate 800mg; sevelamer carbonate 800mg - film coated tablet - 800 mg - active: sevelamer carbonate 800mg excipient: isopropyl alcohol microcrystalline cellulose opacode opadry clear propylene glycol sodium chloride zinc stearate active: sevelamer carbonate 800mg excipient: acetylated monoglycerides hypromellose e-15 hypromellose e-5 isopropyl alcohol microcrystalline cellulose opacode propylene glycol sodium chloride zinc stearate - renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - sevelamer carbonate 1600mg - powder for oral suspension - 1.6 g - active: sevelamer carbonate 1600mg excipient: 'natural and artificial citrus cream' proprietary flavouring iron oxide yellow propylene glycol alginate sodium chloride sucralose - renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - sevelamer carbonate 2400mg - powder for oral suspension - 2.4 g - active: sevelamer carbonate 2400mg excipient: 'natural and artificial citrus cream' proprietary flavouring iron oxide yellow propylene glycol alginate sodium chloride sucralose - renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - sevelamer carbonate - hyperphosphatemia; renal dialysis - all other therapeutic products - renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.renvela 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.

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

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

sanofi-aventis australia pty ltd - sevelamer carbonate -

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

sanofi-aventis australia pty ltd - sevelamer carbonate -

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

sanofi-aventis australia pty ltd - sevelamer carbonate -

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

atlantic biologicals corps - 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 high-dose groups (hu

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

carilion materials management - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients 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 or to any of the excipients. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. sevelamer products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of sevelamer hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. in pregnant rats given doses 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 a dose approximately equal to the maximum clinical trial dose of 13 g on a body su