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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:  03/01/2012
 
Trade Name:  Ultresa
 
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 7--17 years "Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience "High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age " Adverse reactions similar to adults "Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended "Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children "Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately "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:  Aptalis Pharma U.S., Inc
 
Therapeutic Category:  Pancreatic enzyme
 
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