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ViroPharma's Buccolam® (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures
Date:9/6/2011

tment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

Hypersensitivity to the midazolam, benzodiazepines or to any of the excipients may occur. Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure, impaired hepatic function or reduced cardiac function.

The most common adverse reactions in clinical trials associated with buccal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting.  No severe adverse events were reported. The safety profile was similar to rectal or intravenous diazepam in the comparative clinical trials.

About Non-Epileptic and Epileptic Seizures

Seizures occur because of sudden and abnormal electrical activity in the brain. There are many causes of seizures affecting pediatric patients; many are the result of epilepsy, but other triggers can include medicines, head injuries, certain diseases, and high fevers (called 'febrile seizures'). Febrile seizures are the most common type of seizure in children; approximately one in every 25 children will have at least one febrile seizure, and more than one-third of these children will have additional febrile seizures before they outgrow the tendency to have them. Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly one percent of the population.  There are approximately six million people affected by epilepsy in Europe; nearly one million European children and adolescents have active epilepsy. Epilepsy commonly causes physical manifestations includ
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SOURCE ViroPharma Incorporated
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