| Document Date: 2014-04-03 11:33:57
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City Reference / / Company Ames / kaleo Inc. / / Event Product Issues / Product Recall / / IndustryTerm natural rubber latex / hydrochloride solution / appropriate healthcare setting / hydrochloride products / administration site / / MedicalCondition small pupils / ventricular tachycardia / prolonged respiratory depression / pulmonary vascular bed resulting / subsequent slow dissociation / seizures / coma / nausea / acute abstinence syndrome / low blood pressure / encephalopathy / pulmonary edema / tachycardia / diarrhea / central nervous system depression / restlessness / cardiac arrest / dyspnea / pulmonary edema / pre-existing cardiovascular disorders / Hypotension / opioid depression / hypertension / convulsions / neurogenic pulmonary edema / Carcinogenesis / acute withdrawal syndrome / body aches / fever / vomiting / runny nose / concomitant disease / acute opioid withdrawal syndrome / cardiac disease / respiratory depression / infection / abdominal cramps / opioid withdrawal syndrome / Neonatal opioid withdrawal syndrome / Fertility Carcinogenesis Long-term / / MedicalTreatment emergency treatment / emergency therapy / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position speaker / red safety guard / / Product sodium chloride / naloxone hydrochloride / naloxone / opioid / syndrome / EVZIO injection / DOSAGE FORMS AND STRENGTHS Injection / Severe Opioid / / Technology 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 EVZIO safely and effectively. See full prescribing information for EVZIO. EVZIO (naloxone hydrochloride injection) A