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: 14/05/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 14/5/2020

Click on this link to Download PDF directly

Correvio

logo_correvio_1554391637

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 14 May 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

  • Black triangle removed – no longer subject to additional monitoring
  • Minor formatting changes

Note: sections only provided where amendments have been made

New text highlighted in blue

Deleted text highlighted in red strikethrough

4.4     Special warnings and precautions for use

Hypersensitivity reactions

DalbavancinXydalba should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction to dalbavancinXydalba occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.

Clostridioides (formerly Clostridium) difficile Clostridium difficile -associated diarrhoea

Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8). In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) Clostridium difficile should be considered. These patients must never be treated with medicinal products that suppress the peristalsis.

4.6     Fertility, pregnancy and lactation

Pregnancy

Xydalba is not recommended during pregnancy, unless clearly necessaryunless the potential expected benefit clearly justifies the potential risk to the foetus.

4.8       Undesirable effects

Tabulated list of adverse reactions (Table 1)

Infections and infestationsUncommon – amended:

vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis

Description of selected adverse reactions

Class adverse reactions

Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic agentmedicinal product, such as an aminoglycoside, may be at increased risk.

6.6     Special precautions for disposal and other handling

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

10.       DATE OF REVISION OF THE TEXT

14/12//201805/12/2019

Updated on 14 May 2020 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to other sources of information section
  • Change to information for healthcare professionals
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

  • Black triangle removed – no longer subject to additional monitoring.

Note: sections only provided where amendments have been made

New text highlighted in blue

Deleted text highlighted in red strikethrough

6.       Contents of the pack and other information

What Xydalba looks like and contents of the pack

Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal. The vial contains white to off-white to pale yellow powder.

It is available in packs containing 1 vial.

6.       Contents of the pack and other information

The local representative section has been updated

6.       Contents of the pack and other information

Information intended for medical/HCP:

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

 

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