Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
PREA(P):
P
Sponsor:
Ortho-McNeil-Janssen
NNPS:
FALSE'
Therapeutic Category:
Pancreatic enzyme
-
-