Evzio(r) Naloxone Hcl
Product Images NDC 51662-1495

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Evzio(r) Naloxone Hcl (NDC 51662-1495). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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2nd Inst 1 (2nd Inst 1)

This text describes the trainer and the outer case of EVZIO, a device used for the emergency treatment of opioid overdoses. The trainer is a reusable device that simulates the use of EVZIO but does not contain any needle or medicine. The outer case of the EVZIO device is different from the trainer in terms of color and design, and it contains a needle and medicine. However, it cannot be reused and has an expiration date. Overall, this text provides information regarding the features and limitations of the EVZIO device and its trainer.*

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2nd Inst 2 (2nd Inst 2)

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Auto Injector Case Label (Auto Injector Case Label)

This text seems to be the instructions and warning labels for a drug injection device called "Evaio". The device is used for opioid emergencies such as suspected overdose. It includes voice instructions from a speaker and should be stored at room temperature without refrigeration. The text mentions removing the device and keeping it in the provided case until it needs to be used. If the solution appears discolored, cloudy, or contains particles, it should not be used. The text also includes hard to read characters and some errors due to .*

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Auto Injector Label (Auto Injector Label)

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Carton Label (Carton Label)

This is a description of a naloxone hydrochloride injection auto-injector called Evzio. It does not contain a needle and is used for opioid emergencies such as suspected overdose. The carton contains three units of auto-injectors and a Trainer for Evzio is not recommended for use in an emergency. The medication contained in each Evzio includes 2mg naloxone hydrochloride, 3.34 mg sodium chloride, and water for injection. It should be stored at room temperature and protected from heat. For further information or questions, call the provided phone number.*

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Clinical 1 (Clinical 1)

Table 1 shows the mean pharmacokinetic parameters for Naloxone administered through Intramuscular/Subcutaneous injection using EVZIO to healthy subjects. The table contains data on different dosages (0.4 mg, 0.8 mg, and 2 mg). The parameters listed are Trnax, Cmax, AUCy, AUCg inf, and Tip along with their corresponding values expressed in units such as ng/mL and ng.h/mL. The values in brackets signify the coefficient of variation (% CV) for each parameter. Median values for Tmax (time to reach maximum concentration) are also provided. Note that one of the parameters was obtained for N=23 rather than 24.*

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Clinical 2 (Clinical 2)

This appears to be a chart or a table showing the Naloxone plasma concentration in ng/mt after different doses of EVZIO injection at different times post-dose. It indicates that the plasma concentration of Naloxone increases with dosage and peaks at around 0.8 mg dose, with a rapid decline afterwards. It also shows the time post-dose in hours to aid in interpreting the pharmacokinetics of Naloxone.*

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Inst 1 (Inst 1)

The text provides a brief description of EVZIO Parts consisting of 2 mg Outer Case and a component called Figure A. It also states that the EVZIO device does not require any assembly as it comes pre-assembled for use.*

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Inst 2 (Inst 2)

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Inst 3 (Inst 3)

This text provides instructions on how to use the EVZIO auto-injector. It explains how to place the device against the outer thigh and how to react in case of injection failure. Additionally, it is advised to seek emergency medical help immediately after using the device and not to reuse it.*

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Inst 4 (Inst 4)

The text appears to be describing the features of a device called EVZIO, which seems to have a red indicator and a red LED, along with a locked base and a retracted needle. It is suggested to seek emergency help when the red indicator is turned on. The purpose of the device and the context in which it is used are not clear from the given text.*

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Serialized Carton Labeling (Serialized Carton Labeling)

This product is an auto-injector designed for use during opioid emergencies such as suspected overdose. The package contains three units, including one Evzio Auto-Injector and a Trainer. The Trainer has been assembled in China, and the product has a GTIN of 00360842051012, a SN of 000000056360, an expiry date of 01-2020, and a LOT number of FO207918BB. The product is required to be handled with special care by Californians due to the presence of batteries containing Perchlorate Material. For more information on handling such products, please visit www.dtsc.ca.gov/hazardouswaste/perchlorate.*

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Structure (Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.