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Dexdor 100 micrograms/ml concentrate for solution for infusion

  • Name:

    Dexdor 100 micrograms/ml concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Dexmedetomidine hydrochloride

  • 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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Summary of Product Characteristics last updated on medicines.ie: 17/1/2020

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

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Medicine Name Dexdor 100 micrograms/ml concentrate for solution for infusion Active Ingredients Dexmedetomidine hydrochloride
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1 - 0 of 24 items.Total: Infinity pages

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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

The information around use in pregnancy has been updated (section 4.6)
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 SPC

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

Update of sections 2 and 6.6 of the SmPC in order to propose an alternative, higher final concentration for administration (8 micrograms/ml) to limit the fluid load for patients on fluid restriction. Update of section 6.4 of the SmPC to recommend to the ampoules or vials to be kept in the outer carton in order to protect from light.

Updated on 23 July 2015 PIL

Reasons for updating

  • Change to packaging
  • Change to storage instructions

Updated on 29 December 2014 SPC

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

Update of sections 4.4 and 4.8 of the SmPC in order to add a warning and update the safety information on respiratory depression and apnoea. Update of section 4.5 of the SmPC to add information on enhancement of effects, including sedative, anaesthetic and cardiorespiratory effects.

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 SPC

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

A new pack presentation has been added to section 2

Updated on 2 April 2013 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 12 February 2013 SPC

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

Correction of error in section 10 of the document.

Updated on 1 February 2013 SPC

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

Sections 4.2, 4.8, 5.1 and 5.2 have been updated as a result of the review of paediatric data in the text.  Please note there is no paediatric indication for the product.

Updated on 30 January 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 21 October 2011 SPC

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

Legal category amended

Updated on 7 October 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 October 2011 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided