Dexdomitor

dexmedetomidine hydrochloride

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Dexdomitor?

Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action. It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).

What is Dexdomitor used for?

Dexdomitor is used to sedate (calm down) dogs and cats in the following situations: 

  • when carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated, and made less sensitive to pain (analgesia). It is used in noninvasive procedures. This means that the procedure does not involve breaking the skin or a body cavity;
  • before inducing general anaesthesia. When used in cats, ketamine should be used as the anaesthetic agent;
  • for deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.

The dose is chosen according to the species being treated, the use, whether it is given by intravenous (into a vein) or intramuscular (into a muscle) injection and any other medicines that are also being used. The dose depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats. In dogs, Dexdomitor is given by intravenous or intramuscular injection. In cats, it is given by intramuscular injection. The duration and depth of sedation and analgesia depend on the dose that is used.

How does Dexdomitor work?

Dexmedetomidine is an alpha2-adrenoceptor agonist. It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain. Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.

How has Dexdomitor been studied?

Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine. The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia. In dogs, both intravenous and intramuscular injections of Dexdomitor were studied.

Dexdomitor was also compared with medetomidne for premedication (sedation prior to anaesthesia) in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol. Finally, it was studied as a premedication in dogs and cats prior to induction of general anaesthesia.

What benefit has Dexdomitor shown during the studies?

The studies showed that Dexdomitor had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats. As for medetomidine, ‘good’ or ‘excellent’ analgesia was reached in about 40 to 50% of the animals, supporting its used in noninvasive mildly to moderately painful procedures.

Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine. Dexdomitor also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and for premedication in dogs and cats before induction of general anaesthesia, reducing the amount of anaesthetic that the dogs and cats require.

What is the risk associated with Dexdomitor?

Dexdomitor causes a decrease in heart rate and body temperature. In addition, the blood pressure will increase before returning to normal or below normal. In some dogs and cats, there may be a decrease in breathing rate and the mucous membranes may appear pale or with a blue tinge. Vomiting may occur five to 10 minutes after injection or at the time of recovery. Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation. Other side effects can occur when Dexdomitor is used with other medicines. For a full list of all side effects reported with Dexdomitor, see the package leaflet.

It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole-body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.

The safety of the use of Dexdomitor has not been studied in puppies below 16 weeks of age or in kittens below 12 weeks of age.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

If Dexdomitor is accidentally self-injected or taken by mouth, medical advice should be sought immediately and the package leaflet or the label shown to the doctor. However, the person should not drive due to the risk of sedation and changes in blood pressure. Contact with the skin, eyes or mucous membranes (moist body surfaces) should be avoided. If contact does occur, rinsing with large amounts of water is advised. The use of waterproof gloves is advisable. Pregnant women should take special care to avoid self-injection. People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.

Why has Dexdomitor been approved?

The CVMP concluded that the benefits of Dexdomitor exceed the risks and recommended that it be given a marketing authorisation. The benefit / risk balance may be found in the scientific discussion module of this EPAR.

Other information about Dexdomitor

The European Commission granted a marketing authorisation valid throughout the European Union for Dexdomitor on 30 August 2002. The marketing authorisation was renewed on 2 August 2007. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Dexdomitor : EPAR - Summary for the public BG = bălgarski 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public ES = español 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public CS = čeština 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public DA = dansk 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public DE = Deutsch 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public ET = eesti keel 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public EL = elliniká 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public EN = English 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public FR = français 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public IT = italiano 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public LV = latviešu valoda 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public LT = lietuvių kalba 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public HU = magyar 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public MT = Malti 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public NL = Nederlands 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public PL = polski 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public PT = português 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public RO = română 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public SK = slovenčina 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public SL = slovenščina 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public FI = suomi 2009-12-14 2012-10-08
Dexdomitor : EPAR - Summary for the public SV = svenska 2009-12-14 2012-10-08

This EPAR was last updated on 08/11/2017 .

Authorisation details

Product details

Product details for Dexdomitor
NameDexdomitor
Agency product numberEMEA/V/C/000070
Active substance

dexmedetomidine hydrochloride

International non-proprietary name (INN) or common name

dexmedetomidine

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codes QN05CM18







Publication details

Publication details for Dexdomitor
Marketing-authorisation holder

Orion Corporation

Revision17
Date of issue of marketing authorisation valid throughout the European Union30/08/2002

Contact address:

Orion Corporation
Orionintie 1
FIN-02200 Espoo
Finland

Product information

Product information

18/10/2017  Dexdomitor -EMEA/V/C/000070 -IAIN/0036

Name Language First published Last updated
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08
Dexdomitor : EPAR - Product Information SV = svenska 2009-11-19 2017-11-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19
Dexdomitor : EPAR - All Authorised presentations SV = svenska 2008-03-03 2014-03-19

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Premedication in cats before induction and maintenance of general anaesthesia with ketamine.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs before induction and maintenance of general anaesthesia.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Dexdomitor : EPAR - Procedural steps taken before authorisation SV = svenska 2005-10-21  
Dexdomitor : EPAR - Scientific Discussion SV = svenska 2005-10-21