Basic Information
Dexmedetomidine Accord
Regulatory Information
January 25, 2023
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Overview Summary
Dexmedetomidine Accord is a medicine used to sedate (calm or make sleepy) adults in the following settings: - in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale); - before or during diagnostic or surgical procedures where the patient remains awake (awake sedation). Dexmedetomidine Accord contains the active substance dexmedetomidine. Dexmedetomidine Accord is a ‘generic medicine’. This means that Dexmedetomidine Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Dexdor.