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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:  04/12/2010
 
Trade Name:  Pancreaze
 
Generic Name or Proper Name (*):  pancrelipase
 
Indications Studied:  Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
 
Label Changes Summary:  Safety and efficacy assessed in 2 studies that included patients 6-30 months and 8--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 containing the same active ingredient High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age Adverse reactions 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:  Ortho-McNeil-Janssen
 
NNPS:  FALSE'
 
Therapeutic Category:  Pancreatic enzyme
 
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