| Document Date: 2014-10-14 11:58:22
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Event Product Issues / Product Recall / / Facility Store BUNAVAIL / / IndustryTerm buprenorphine sublingual solutions / machinery / food / hazardous machinery / buprenorphine products / fixed-dose combination product / combination product / fixed combination product / buprenorphine product / / MedicalCondition anaphylactic shock / myoclonus / headache / CNS Depression / neonatal withdrawal syndrome / hives / cytolytic hepatitis / coma / dysfunction / apnea / respiratory depression / nausea / prostatic hypertrophy / hepatitis C / hepatitis B / hyperhidrosis / hepatic necrosis / withdrawal syndrome / bradycardia / Hypersensitivity / Hepatitis / constipation / pruritus / hepatorenal syndrome / head injury / insomnia / toxic psychoses / bronchospasm / urethral stricture / hypothyroidism / Carcinogenesis / chronic obstructive pulmonary disease / acute hepatitis / hepatic encephalopathy / increased CNS depression / chronic administration / Orthostatic Hypotension / Addison’s disease / vomiting / pain / hypertonia / neonatal tremor / fatal / respiratory depression / acute alcoholism / myxedema / hepatic failure / Allergic Reactions / Drug Abuse / Significant respiratory depression / Respiratory Depression / infection / delirium tremens / opioid withdrawal syndrome / miosis / angioneurotic edema / cor pulmonale / / MedicalTreatment counseling / psychotherapy / pharmacotherapy / / Movie CIII Initial U.S / / Organization Chronic administration / _______________DOSAGE AND ADMINISTRATION / FDA / / / Position Secretary of Health / physician / General / / Product Neonatal Withdrawal Neonatal / signs / Neonatal / Sublingual Tablet / Sublingual Tablets / Use / naloxone / SUBOXONE / Opioid / syndrome / Hepatic Function Impairment / machinery / / Technology drug screening / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BUNAVAIL safely and effectively. See full prescribing information for BUNAVAIL.