| Document Date: 2012-05-22 07:50:44
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City Burkhart / Stallings / Reference / / Company AEs / USP / Digestive Care Inc. / New England Journal / / Event FDA Phase / / Facility Handling Store / / IndustryTerm acidic soft food / pancrelipase products / immediate-release pancreatic enzyme products / soft acidic food / food mixture / healthcare / pancrelipase product / pancreatic enzyme products / food / food consumption / manufacturing / soft food mixture / healthcare professional / / MedicalCondition Allergic Reaction / skin disorders / hives / dull headache / nausea / exocrine pancreatic insufficiency / anaphylaxis / infectious illness / mucosal irritation / Chronic high doses / distal intestinal obstruction syndrome / gout / chronic pancreatitis / infectious agent / diarrhea / cystic fibrosis / constipation / pruritus / gastrointestinal disorders / asthma / malnutrition / severe allergic reactions / abdominal pain / mild allergic reaction / pre-existing carcinoma / severe allergy / steatorrhea present / Adverse Reaction Diarrhea Dyspepsia Cough PERTZYE / Carcinogenesis / red / blotchy rash / hyperuricemia and allergic reactions / allergy / viral disease / pancreatic insufficiency / urticaria / diseases / Allergic Reactions / Irritation / steatorrhea / cough / rash / / MedicalTreatment nutritional support / enzyme replacement therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product ursodiol / sodium bicarbonate / talc / PERTZYE capsules / Delayed-Release Capsules / PERTZYE / / ProvinceOrState Virginia / South Carolina / Georgia / / PublishedMedium New England Journal of Medicine / / Region New England / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PERTZYE safely and effectively. See full prescribing information for PERTZYE. PERTZYE (pancrelipase) delayed-release