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Company Boehringer Ingelheim Pharmaceuticals Inc. / / Event FDA Phase / Product Issues / / Facility Poison Control Center / Laboratory Tests Changes / / IndustryTerm treatment for diabetes / food / biguanide combination product / / MedicalCondition hyperinsulinemia / Lactic Acidosis Metformin Lactic acidosis / acidosis / headache / OF LACTIC ACIDOSIS / urinary tract infection / nausea / anaphylaxis / angioedema / exfoliative skin conditions / Metformin Hypoglycemia / diabetic ketoacidosis / obesity / hypersensitivity / diarrhea / type 2 diabetes mellitus / bronchial hyperreactivity / chronic metabolic acidosis / constipation / Hypoglycemia / pruritus / resistant bradyarrhythmias / dose-dependent metabolic acidosis / hepatic disease / neurologic manifestations / sepsis / hypotension / acute myocardial infarction / megaloblastic anemia / congestive heart failure / acute congestive heart failure / Vitamin B12 deficiency / OF LACTIC ACIDOSIS Lactic acidosis / metformin-induced lactic acidosis / nasopharyngitis / both intrinsic renal disease / hypertriglyceridemia / shock / Carcinogenesis / Metabolic acidosis / hyperglycemia / serious disease / hypothermia / migraine / congestive heart failure requiring pharmacologic management / diabetes / hyperlipidemia / azotemia / metabolic acidosis lacking evidence / septicemia / serious hypersensitivity / poorly-controlled diabetes / vomiting / fatal pancreatitis / myocardial infarction / Lactic acidosis / diabetes mellitus / urticaria / angioedema / pancreatitis / epilepsy / cough / acute pancreatitis / Cause Hypoglycemia / Rash / severe acidosis / anemia / respiratory distress / dehydration / pituitary insufficiency / / MedicalTreatment oral contraceptives / peritoneal dialysis / insulin therapy / hemodialysis / / NaturalFeature Himalayan / / Organization US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / Major / / Product pioglitazone / topiramate / ranitidine / trimethoprim / glucagon / Glimepiride / zonisamide / cimetidine / isoniazid / acetazolamide / rifampin / JENTADUETO tablets / phenytoin / talc / Indication JENTADUETO tablets / digoxin / metformin hydrochloride / CYP3A4 / Hepatic Function / metformin / / Technology alpha / tomography / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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Microsoft Word - Jentadueto supplement 006 approval 30 July 2014.doc