| Document Date: 2015-05-22 15:56:17
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City Bagsvaerd / Plainsboro / / Company Phe Val Asn Gln / Novo Nordisk A/S / Ames / Novo Nordisk Inc. / / Country Denmark / / Event FDA Phase / Product Issues / / Facility I store NovoLog / store NovoLog / / IndustryTerm injection site / technology utilizing / machinery / rubber / healthcare / sympatholytic products / food / energy / metal / oral antidiabetic products / insulin product / food intake / Diabetes Care / insulin products / erratic food intake / / MedicalCondition anaphylactic reaction / hypoglycemia unawareness / postprandial hyperglycemia / Hypoglycemia Hypoglycemia / lymphoma / transitory / reversible ophthalmologic refraction disorder / headache / unconsciousness / maternal hypoglycemia / mammary gland tumors / sterility / coma / anaphylaxis / glycosuria / gestational diabetes / drowsiness / injury / diabetic ketoacidosis / obesity / hypersensitivity / generalized allergy / Type 2 Diabetes Mellitus / Preferred Term Hypoglycemia Headache Influenza-like / illness / hypoglycemia / pruritus / Back pain / birth defects / Lipodystrophy Long-term / wheezing / acute painful peripheral neuropathy / ventricular arrhythmia / light-headedness / diabetic retinopathy / lipodystrophy / respiratory tract infection Headache Diarrhea Neuropathy Pharyngitis Abdominal pain Rhinitis NovoLog / OVERDOSAGE Hypoglycemia / respiratory paralysis / intensified diabetes / diabetic complications / shortness of breath / Carcinogenesis / hyperglycemia / mammary tumors / diabetes / erythema / itching / allergy / seizure / pain / respiratory tract infection NovoLog / concomitant disease / diabetes mellitus / heart failure / allergic reactions / diabetic nerve disease / infectious diseases / Severe hypoglycemia / infection / dizziness / hypokalemia / rash / / MedicalTreatment medication errors / oral contraceptives / antibiotics / insulin therapy / insulin injections / insulin delivery / drug therapy / insulin pump / / Organization U.S. Food and Drug Administration / DOSAGE AND ADMINISTRATION / FDA / / Person Blood Glucose (Plasma) / Ser Ile Cys Ser / Ser Leu Tyr / / / Position pharmacist / Physician / forward / / Product NovoLog / pioglitazone / reserpine / protamine sulfate / sodium chloride / glucagon / Novolin / niacin / danazol / isoniazid / fluoxetine / epinephrine / NovoLog® Mix / pharmacodynamic profile / / ProvinceOrState New Jersey / / PublishedMedium Baseline / / RadioStation Mix 70 / / Technology antibodies / Pharmacokinetics / Pharmacodynamics / recombinant DNA technology / / URL www.fda.gov/medwatch / http /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NovoLog® Mixsafely and effectively. See full prescribing information for NovoLog® Mix 70/30. ——— ADV