Xydalba 500 mg powder for concentrate for solution for infusion

  • Name:

    Xydalba 500 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Dalbavancin 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: 24/01/19

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Summary of Product Characteristics last updated on medicines.ie: 24/1/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Company Products

Medicine NameActive Ingredients
Medicine Name Brinavess 20 mg/ml concentrate for solution for infusion Active Ingredients Vernakalant Hydrochloride
Medicine Name Xydalba 500 mg powder for concentrate for solution for infusion Active Ingredients Dalbavancin hydrochloride
1 - 0 of 2 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 24 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to information for healthcare professionals

Updated on 24 January 2019 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

New text highlighted in blue

6.6     Special precautions for disposal and other handling

If a common intravenous line is being used to administer other drugs in addition to Xydalba, the line should be flushed before and after each Xydalba infusion with 5% glucose solution for infusion.

Updated on 3 October 2017 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

New text highlighted in blue

Deleted text highlighted in red

 

 

4.8       Undesirable effects

HPRA national reporting system details included

 

6.3       Shelf life

Dry powder: 34 years

 

7.         MARKETING AUTHORISATION HOLDER

Durata Therapeutics International B.V.

Spaces Zuidas II,

Barbara Strozzilaan 101,

1083HN Amsterdam

The Netherlands

Allergan Pharmaceuticals International Ltd.,

Clonshaugh Industrial Estate, Coolock,

Dublin 17,

Ireland

 

10.       DATE OF REVISION OF THE TEXT

 

27/01//2017

 

Updated on 3 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 October 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 2 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 December 2016 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 12 December 2016 PIL

Reasons for updating

  • New PIL for medicines.ie