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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  08/27/2009
 
Trade Name:  Zenpep
 
Generic Name or Proper Name (*):  pancrelipase
 
Indications Studied:  Exocrine pancreatic insufficiency due to cystic fibrosis
 
Label Changes Summary:  Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 years Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase with the same active ingredient. High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in children <12 years of age AEs similar to adults Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce Information on dosing, and clinical studies Not interchangeable with other pancrelipase products New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Eurand
 
NNPS:  FALSE'
 
Therapeutic Category:  Pancreatic enzyme
 
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