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City Birmingham / St. Hubert / Reference / / Company APTALIS Pharma US Inc. / USP / VIOKACE / New England Journal / Confab Laboratories Inc. / / Country United States / / Event FDA Phase / Product Issues / / IndustryTerm treatment / pancreatic enzyme replacement product / pancrelipase product / pancreatic enzyme products / food / food consumption / enzyme products / placebo / manufacturing / healthcare professional / / MedicalCondition JE / anal pruritus / skin disorders / hives / Urinary Disorders Renal cyst / nausea / exocrine pancreatic insufficiency / anaphylaxis / infectious illness / mucosal irritation / distal intestinal obstruction syndrome / Chronic high doses / gout / Infestations Viral infection / chronic pancreatitis / infectious agent / diarrhea / cystic fibrosis / constipation / pruritus / Infections / gastrointestinal disorders / asthma / malnutrition / severe allergic reactions / Abdominal pain / General Disorders / pre-existing carcinoma / severe allergy / steatorrhea present / Carcinogenesis / hyperuricemia and allergic reactions / allergy / viral disease / pancreatic insufficiency / concomitant disease / Lactose Intolerance VIOKACE / urticaria / diseases / Allergic Reactions / lactose intolerance / irritation / Nervous System Disorders Headache / steatorrhea / rash / Blood And Lymphatic System Disorders Anemia / skin and subcutaneous tissue disorders rash / / MedicalTreatment nutritional support / enzyme replacement therapy / drug therapy / / Organization American Dietetic Association / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product HOW SUPPLIED/STORAGE AND HANDLING VIOKACE tablets / Each VIOKACE tablet / cimetidine / VIOKACE tablets / talc / Lactose Intolerance VIOKACE tablets / VIOKACE / treatment / / ProvinceOrState Alabama / / 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 VIOKACE safely and effectively. See full prescribing information for VIOKACE VIOKACE (pancrelipase) tablets, for ora