Rx Item-Evzio Auto Injector 2 Mg Pfs 2 By Kaleo

EVZIO- naloxone hydrochloride injection, solution
kaleo, Inc.

1 INDICATIONS AND USAGE

EVZIO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric patients.

EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present.

EVZIO is not a substitute for emergency medical care.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions


EVZIO is for intramuscular and subcutaneous use only.

Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of EVZIO and the Instructions for Use.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for EVZIO. Emphasize the following instructions to the patient or caregiver:

Seek emergency medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of EVZIO as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of EVZIO.
Additional doses of EVZIO may be required until emergency medical assistance becomes available.
Do not attempt to reuse EVZIO. Each EVZIO contains a single dose of naloxone.
Visually inspect EVZIO through the viewing window for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the glass container is undamaged.
EVZIO must be administered according to the printed instructions on the device label or the electronic voice instructions (EVZIO contains a speaker that provides voice instructions to guide the user through each step of the injection). If the EVZIO electronic voice instruction system does not operate properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.
Once the red safety guard is removed, EVZIO must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed.
Upon actuation, EVZIO automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone hydrochloride injection, and retracts the needle fully into its housing. Post injection, the black base locks in place, a red indicator appears in the viewing window, and electronic visual and audible instructions signal that EVZIO has delivered the intended dose of naloxone hydrochloride and instructs the user to seek emergency medical attention.

RX ITEM-Evzio Auto Injector 2 Mg Pfs 2 B
NDC 60842-0030-01 UPC/GTIN No.3-60842-03001-7 Mfg.Part No.3001

Evzio Auto Injector 2 Mg Pfs 2 By Kaleo
BRAND: EVZIO AUTO NDC: 60842-0051-01, 60842005101 UPC: 060842-051011,60842051011 Kaleo Inc

NALOXONE HCL INJECTION AU
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