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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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