For more information, ask your doctor or pharmacist. These are not all the possible side effects of Midazolam Injection. Tell the doctor if you have any side effect that bothers you or that does not go away. pain, swelling, redness, blood clots and muscle stiffness at the injection site.The most common side effects of Midazolam Injection include: Get medical help right away, if you have any of the symptoms listed above. Midazolam Injection may cause serious side effects including: What are the possible side effects of Midazolam Injection? Midazolam Injection belongs to a class of drugs called Antianxiety Agents Anxiolytics, Benzodiazepines Anticonvulsants, Benzodiazepine. Midazolam Injection may be used alone or with other medications. Midazolam Injection is a prescription medicine used to treat the symptoms of Status Epilepticus, sedation and anesthesia. Since its inception, FIMI's performance has been exceptional by both local and global standards after having completed close to 100 investments.What is Midazolam Injection and how is it used? Rafa's controlling shareholder, FIMI Opportunity Funds, is the leading private equity fund in Israel with a track record of success spanning over 25 years and assets under management of $7b. Falk and Mundipharma, in a variety of therapeutic areas including oncology, hematology, respiratory, gastroenterology, and dermatology. With a proven track record of successful commercialization of niche and orphan products, Rafa has been privileged to nurture long-lasting alliances with leading innovative companies such as United Therapeutics, Helsinn, Zambon, Galderma, Dr. FDA, EMA) all the way through sales and marketing. Rafa's competencies span over the entire value chain from R&D and manufacturing by international standards (e.g. This product could assist in saving many lives around the globe."įounded in 1937 and headquartered in Jerusalem, Israel, Rafa is among the leading pharmaceutical companies in Israel and a global player in emergency solutions – medical countermeasures, supplying auto-injectors for government agencies, military forces and civilian populations. Clinical studies confirmed the correlation between early treatment of status epilepticus and a reduced risk of an ongoing and irreversible neurological damage. Roy Shay, Head of Emergency Solutions at Rafa, commented: "The usability of the autoinjector has a significant medical advantage in its immediate treatment effect, as well as in reducing long term damage. It is made in Israel and is meaningful news to the world of medical emergency solutions, thus strengthening Rafa's key role in providing reliable products to armies, governments, and first responders worldwide." It is already sold under EUA in other territories and is an important addition to Rafa's current autoinjector portfolio, which includes various formulations for emergency use.Īmir Levin, CEO of Rafa, stated: "We are proud of the FDA approval for this life saving product. The product was developed in Israel and is manufactured at Rafa's manufacturing site in Jerusalem. This is a significant advantage in a field setting during an emergency, when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure. Rafa's innovation resides in the use of an autoinjector to be administered intra muscularly to the thigh (can be administered through clothes as well), in a simple and fast manner which does not require an intravenous line. According to guidelines of the American Epilepsy Society, Midazolam Intra-muscular is a first-line therapy for Status Epilepticus. JPEO-CBRND, the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector.įDA approval was obtained following an expedited review, a testament to the importance and urgent need of the product, with NDA submission and final approval achieved in less than five months through prioritized engagement between the U.S. As such, this new autoinjector can be used to treat seizures resulting from nerve agent exposure. The Midazolam 10 mg autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults.
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