N/a Injection, Solution
Product Images NDC 71053-595

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for N/a (NDC 71053-595). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rafa Laboratories, Ltd., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Aes Clinical Trials (Pi Table1)

A table comparing adverse reaction percentages between IM Midazolam (N=448) and IV Lorazepam (N=445). It lists adverse reactions including upper airway obstruction, agitation, pyrexia, mental status changes, postictal state, and acute renal failure, showing higher occurrence rates for IM Midazolam across all listed categories.*

FDA Label Image

Ifu 1 (Pages From Nda 216359 Approval Letter 2 Page 1)

Instructions for use of Midazolam injection, for intramuscular use, 10 mg/0.7 mL single-dose autoinjector. The text includes guidance on determining if the autoinjector is appropriate based on status epilepticus criteria and patient age, with a flowchart depicting clinical decision steps. It emphasizes that the injection is for treating status epilepticus in adults, single-use only, and not for pediatric patients or other seizure types.*

FDA Label Image

Ifu 2 (Pages From Nda 216359 Approval Letter 2 Page 2)

Instructions for using the Midazolam autoinjector include illustrations and text showing steps: removing the plastic sleeve while avoiding the orange tip, holding the autoinjector with the orange tip down, pulling off the grey safety cap, injecting at a 90° angle into the mid-outer thigh (through clothing if necessary), and holding in place for at least 10 seconds to complete the injection.*

FDA Label Image

Ifu 3 (Pages From Nda 216359 Approval Letter 2 Page 3)

Instructional illustrations and text showing steps for using a Midazolam Injection autoinjector. The top left shows two syringe images indicating needle visibility to confirm injection completion. The bottom left depicts a hand bending the needle of the used autoinjector against a hard surface. The right panel contains detailed steps for post-injection care, including needle visibility check, massage of the injection site, bending the needle, and instructions to seek medical help. Text mentions the single-dose nature of the autoinjector.*

FDA Label Image

480 Count Box (Box Label)

Label for Midazolam Injection 10 mg/0.7 mL autoinjector solution for intramuscular use. Each autoinjector delivers 10 mg Midazolam with hydrochloric acid and sodium chloride. Contains 480 single-dose autoinjectors. Manufactured by Rafa Laboratories, Jerusalem, Israel. Includes NDC 71053-595-01 and storage instructions to avoid freezing.*

FDA Label Image

Structure (Midazolam Structure)

Chemical structure diagram of Midazolam, showing its molecular framework with chlorine and fluorine substituted aromatic rings and fused nitrogen-containing rings.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.