Dexdor 100 micrograms/ml concentrate for solution for infusion
*Company:
Orion Pharma (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 July 2022
File name
Dexdor SPC July 2022 - Ireland ROI.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Information added to Section 4.4 - Special warning and precautions for use concerning the increased risk of mortality in intensive care unit (ICU) patients ≤65 years.
Updated on 22 July 2022
File name
Dexdor Package leaflet July 2022 - Ireland ROI.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
The patient leaflet has been updated to include information an increased mortality risk has been seen for patients 65 years of age and under when using this medicine, especially for patients admitted to the intensive care unit for other reasons than after surgery with a more severe disease condition on admission to the intensive care unit and with a younger age.
Updated on 11 January 2022
File name
Dexdor Package leaflet December 2021 IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The package leaflet is updated to include information on diabetes insipidus being reported in association with dexmedetomidine treatment.
Updated on 11 January 2022
File name
Dexdor SPC December 2021 IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 of the Summary of Product Characteristics updated to include information on diabetes insipidus being reported in association with dexmedetomidine treatment.
Updated on 15 May 2020
File name
Dexdor Package leaflet May20 IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Contact details for Bulgarian representative office updated
Updated on 17 January 2020
File name
Dexdor Package leaflet Jan20 IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The following information has been added to the package leaflet:
Section 2: if you have an abnormally slow heart rate (either due to illness or physical fitness) as it may increase the risk for cardiac arrest
Section 4: cardiac arrest
Updated on 17 January 2020
File name
Dexdor SPC Jan20 IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the Summary of Product Characteristics have addtional information added and updated:
Section 4.4: Also cases of cardiac arrest, often preceded by bradycardia or atrioventricular block, have been reported (see section 4.8)
Section 4.8: Cardiac arrest
Updated on 24 January 2019
File name
Dexdor Package leaflet January 2019 IE.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 24 January 2019
File name
Dexdor SPC Jan2019 IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use : Information regarding hyperthermia has been updated
Section 4.9: Overdose: Information regarding the common symptoms of overdose has been updated.
File name
dexdor Package leaflet Oct 18 IE.pdf
Updated on 16 October 2018
File name
dexdor SPC Oct2018 IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 has been updated to include more information on malignant hyperthermia.
Updated on 04 September 2018
File name
Dexdor Package leaflet August 2018 Ireland.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Updated on 04 September 2018
File name
Dexdor SPC August 2018 Ireland.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
An additional indication has been added to the SPC for Dexdor. The product is now also indicated for sedation of non-intubated adult pateints prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation. As a consequence other sections of the SPC have been updated to provide more information on dosage, warnings, precautions and undesirable effects of dexdor in this indication.
Updated on 16 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2016
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In addition, the term dexdor has been substituted by dexmedetomidine throughout the text.
Updated on 15 September 2016
File name
PIL_15159_633.pdf
Reasons for updating
- New PIL for new product
Updated on 15 September 2016
Reasons for updating
- Change to, or new use for medicine
Updated on 28 July 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 July 2015
Reasons for updating
- Change to packaging
- Change to storage instructions
Updated on 29 December 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 December 2014
Reasons for updating
- Change to side-effects
Updated on 10 March 2014
Reasons for updating
- Change to date of revision
Updated on 08 April 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 02 April 2013
Reasons for updating
- Introduction of new pack/pack size
Updated on 12 February 2013
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 February 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 January 2013
Reasons for updating
- Change to date of revision
Updated on 21 October 2011
Reasons for updating
- Addition of legal category
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 October 2011
Reasons for updating
- New PIL for new product
Updated on 06 October 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)