FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
L'Agenzia Italiana del Farmaco rende disponibili nuove e importanti informazioni, concordate con l'Agenzia Europea dei Medicinali, sull'uso Reminyl (galantamina bromidrato).
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
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