Dexmedetomidine Accord
Authorised
This medicine is authorised for use in the European Union
dexmedetomidine
MedicineHumanAuthorised
Overview
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.
Dexmedetomidine Accord can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.
Dexmedetomidine Accord is given by infusion (drip) into a vein using a controlled infusion device.
When Dexmedetomidine Accord is used in intensive care, the dose is adjusted to achieve the desired level of sedation. If sedation with the maximum dose is not adequate, the patient should be switched to other medicines.
When Dexmedetomidine Accord is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect. In some cases, the patient is also given a local anaesthetic, painkillers and other sedative medicines. The patient’s blood pressure, heart rate, breathing and oxygen levels should be monitored closely during the procedure.
Care should be taken when using Dexmedetomidine Accord in patients with reduced liver function and the dose may be reduced.
For more information about using Dexmedetomidine Accord, see the package leaflet or contact your doctor or pharmacist.
The active substance in Dexmedetomidine Accord, dexmedetomidine, is a selective alpha-2 receptor agonist. It works by acting on receptors (targets) in the brain called alpha-2 receptors and reducing the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate. By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Dexdor, and do not need to be repeated for Dexmedetomidine Accord.
As for every medicine, the company provided studies on the quality of Dexmedetomidine Accord. There was no need for ‘bioequivalence’ studies to investigate whether Dexmedetomidine Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Dexmedetomidine Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Because Dexmedetomidine Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Dexmedetomidine Accord has been shown to be comparable to Dexdor. Therefore, the Agency’s view was that, as for Dexdor, the benefits of Dexmedetomidine Accord outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexmedetomidine Accord have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dexmedetomidine Accord are continuously monitored. Side effects reported with Dexmedetomidine Accord are carefully evaluated and any necessary action taken to protect patients.
Dexmedetomidine Accord received a marketing authorisation valid throughout the EU on 13 February 2020.
Product information
Latest procedure affecting product information: IB/0011
24/01/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Dexmedetomidine Accord
- Active substance
- dexmedetomidine
- International non-proprietary name (INN) or common name
- dexmedetomidine
- Therapeutic area (MeSH)
- Premedication
- Anatomical therapeutic chemical (ATC) code
- N05CM18
Pharmacotherapeutic group
PsycholepticsTherapeutic 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.
News on Dexmedetomidine Accord
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