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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZUBSOLV® safely and effectively. See full prescribing information for ZUBSOLV. •
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Document Date: 2015-03-03 23:40:11


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Company

Ames / /

Currency

pence / /

Event

Product Recall / Product Issues / /

IndustryTerm

buprenorphine sublingual solution / machinery / mg solution / hazardous machinery / buprenorphine products / Healthcare professionals / prokaryotic and eukaryotic systems / combination products / buprenorphine sublingual solutions / sublingual products / treatment of neonatal abstinence syndrome / parallel / fixed-dose combination product / buprenorphine solution / combination product / fixed combination product / chemical structure / buprenorphine product / /

MedicalCondition

omphalocele / Leydig cell tumors / HIV / Neonatal Abstinence Syndrome / seizures / Fetal/neonatal adverse reactions Neonatal abstinence syndrome / hives / coma / dysfunction / prostatic hypertrophy / fatal respiratory depression / hepatitis B / drug dependence / bradycardia / Diarrhea / Hepatitis / Whole Abscess / birth defects / Flu Syndrome / hypoventilation / urethral stricture / hypothyroidism / Chills / Carcinogenesis / preterm birth / acute hepatitis / chronic buprenorphine treatment / hepatic encephalopathy / chronic administration / Orthostatic Hypotension / dystocia / vomiting / acute alcoholism / myxedema / HCV infection / Allergic Reactions / significant respiratory depression / respiratory depression / infection / drug-related tumors / delirium tremens / renal failure / Depression / miosis / angioneurotic edema / cor pulmonale / Dizziness Insomnia / anaphylactic shock / myoclonus / CNS Depression / headache / neonatal withdrawal syndrome / cytolytic hepatitis / apnea / respiratory depression / nausea / hepatitis C / hyperhidrosis / hepatic necrosis / tremor / withdrawal syndrome / Neonatal Abstinence Syndrome Neonatal abstinence syndrome / Addison's disease / hypersensitivity / constipation / pruritus / hepatorenal syndrome / head injury / hypotension / insomnia / toxic psychoses / bronchospasm / buprenorphine-induced respiratory depression / Leydig cell adenomas / chronic obstructive pulmonary disease / increased drowsiness / aluminum/aluminum child resistant unit dose blister / increased CNS depression / pain / hypertonia / neonatal tremor / concomitant disease / hepatic failure / Drug Abuse / severe and fatal respiratory depression / fetal death / opioid withdrawal syndrome / Pharyngitis / /

MedicalTreatment

pharmacotherapy / dialysis / antibiotics / counseling / psychotherapy / drug therapy / /

Organization

Chronic administration / DOSAGE AND ADMINISTRATION / FDA / Dietary administration / /

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Position

Secretary of Health / physician / General / /

Product

Action ZUBSOLV / efavirenz / SC / signs / naloxone HCl / erythromycin / phenytoin / Suboxone / Opioid / Unused ZUBSOLV Sublingual Tablets / syndrome / Suboxone 8 / nevirapine / ZUBSOLV tablet / One 5.7 mg/1.4 mg ZUBSOLV tablet / carbamazepine / Neonatal / mannitol / One 8 mg / naloxone / General Precautions ZUBSOLV / 3x10 / ketoconazole / Operate Machinery ZUBSOLV / One 8.6 mg/2.1 mg ZUBSOLV tablet / BP / Maintenance ZUBSOLV / Hepatic Function / subjects / /

PublishedMedium

the Medication Guide / /

Technology

drug screening / dialysis / alpha / Pharmacokinetics / DNA synthesis / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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