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Product Label Images

The following 6 images provide visual information about the product associated with N/a NDC 71053-595 by Rafa Laboratories, Ltd., such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

AEs clinical trials - PI Table1

AEs clinical trials - PI Table1

This appears to be a table showing adverse reactions to IM Midazolam and IV Lorazepam. The table shows the number of cases (N), percentages (%), and specific adverse reactions experienced by patients. The adverse reactions include upper airway obstruction, agitation, pyrexia (fever), mental status changes, postictal state (after a seizure), and acute renal failure.*

ifu 1 - Pages from NDA 216359 Approval Letter 2 Page 1

ifu 1 - Pages from NDA 216359 Approval Letter 2 Page 1

This is a set of instructions for the use of Midazolam injection, a medication used for the treatment of status epilepticus in adults, through a 10mg/0.7mL prefilled autoinjector. The instructions provide important precautions and safety instructions, such as the need for administration by a healthcare provider or someone trained in treating seizures and basic airway management, the one-time use of each autoinjector, and the inappropriateness of dose adjustment for pediatric patients. A helpful flow chart is also provided to determine eligibility for treatment with Midazolam based on the defined status epilepticus criteria and age of the patient.*

ifu 2 - Pages from NDA 216359 Approval Letter 2 Page 2

ifu 2 - Pages from NDA 216359 Approval Letter 2 Page 2

This text provides step-by-step instructions for using a Midazolam Autoinjector, including how to remove it from its plastic sleeve, how to inject it into the mid-outer thigh, and how to hold it in place for at least 10 seconds. It also gives a note for people who do not have enough fat at the injection site.*

ifu 3 - Pages from NDA 216359 Approval Letter 2 Page 3

ifu 3 - Pages from NDA 216359 Approval Letter 2 Page 3

This text provides instructions for the administration of a single dose of Midazolam using an autoinjector. It includes steps for injection, monitoring, and disposal of the used autoinjector. The text also includes information for troubleshooting and what to do if the injection is not completed. It is recommended to monitor the patient's respiratory and cardiac function continuously after the administration of the autoinjector until the patient stabilizes. The autoinjector should be disposed of properly, and medical help should be sought immediately if needed. The autoinjector is manufactured and distributed by Rafa Laboratories, Ltd.*

480 count box - box label

480 count box - box label

This is a description of Midazolam Injection 10 mg/0.7 mL in an autoinjector, which can be used to treat status epilepticus in adults. Each autoinjector contains 10 mg of Midazolam, Hydrochloric Acid, and Sodium Chloride. The product is manufactured by Rafa Laboratories in Jerusalem, Israel and is available in a package of 480 single-dose autoinjectors. It should be stored between 20°C to 25°C (68°F to 77°F) but can be kept in excursions from 15°C to 30°C (59°F to 86°F). The product has an expiry date of MMM YYYY and should not be frozen.*

structure - midazolam structure

structure - midazolam structure

* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.