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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
11/25/2016
Trade Name:
Renvela
Generic Name or Proper Name (*):
sevelamer carbonate
Indications Studied:
Control of serum phosphorus in children 6 years of age and older with chronic kidney disease on dialysis
Label Changes Summary:
*Expanded the indication from adults to pediatric patients ages 6 years and older. *Renvela has not been studied in pediatric patients below 6 years of age. *Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. *Information on starting dose and titration, adverse reactions and clinical trial. *Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Genzyme
NNPS:
FALSE
Therapeutic Category:
Phosphate binder
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