Dexdor 100 micrograms/ml concentrate for solution for infusion
- Name:
Dexdor 100 micrograms/ml concentrate for solution for infusion
- Company:
Orion Pharma (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/05/20
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Orion Pharma (Ireland) Ltd
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 15 May 2020 PIL
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 24 January 2019 SmPC
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.
Updated on 17 October 2018
Updated on 16 October 2018 SmPC
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 4 September 2018 PIL
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 4 September 2018 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2016 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 15 September 2016 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 28 July 2015 SmPC
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 PIL
Reasons for updating
- Change to packaging
- Change to storage instructions
Updated on 29 December 2014 SmPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 10 March 2014 PIL
Reasons for updating
- Change to date of revision
Updated on 8 April 2013 SmPC
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 2 April 2013 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 12 February 2013 SmPC
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 1 February 2013 SmPC
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 PIL
Reasons for updating
- Change to date of revision
Updated on 21 October 2011 SmPC
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 7 October 2011 PIL
Reasons for updating
- New PIL for new product
Updated on 6 October 2011 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)