Xydalba 500 mg powder for concentrate for solution for infusion
*Company:
ADVANZ PharmaStatus:
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 28 October 2024
File name
Xydalba 500 mg powder for concentrate for solution for infusion.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 December 2022
File name
XYDALB~1.PDF
Reasons for updating
- 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
Paediatric indication
Updated on 20 December 2022
File name
XYDALB~2.PDF
Reasons for updating
- Change to section 3 - use in children/adolescents
Free text change information supplied by the pharmaceutical company
Paediatric indication
Updated on 15 July 2022
File name
XYDALB~2.PDF
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 July 2022
File name
XYDALB~1.PDF
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 May 2021
File name
Xydalba PIL_UK+IE_ 25 Jan 2021.pdf
Reasons for updating
- Change due to harmonisation of PIL
Updated on 24 May 2021
File name
Xydalba PIL_UK+IE_ 25 Jan 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 24 May 2021
File name
Xydalba SmPC 26 Oct 2020.pdf
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2021
File name
Xydalba PIL_EN_ 25 Jan 2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 May 2020
File name
Xydalba 500 powder for concentrate for solution for infusion-SPC-v4-Dec2019-IE.pdf
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 infestations – Uncommon – 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
File name
Xydalba 500 powder for concentrate for solution for infusion-PIL-v4Dec2019-IE.pdf
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
File name
Xydalba 500 powder for concentrate for solution for infusion-PIL-v3-Dec2018.pdf
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
File name
Xydalba 500 powder for concentrate for solution for infusion-SPC-v3-Dec2018.pdf
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 03 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 October 2017
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 02 October 2017
File name
PIL_17005_322.pdf
Reasons for updating
- New PIL for new product
Updated on 02 October 2017
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 13 December 2016
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
Updated on 12 December 2016
Reasons for updating
- New PIL for medicines.ie
ADVANZ Pharma

Address:
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United KingdomMedical Information E-mail:
medicalinformation@advanzpharma.comTelephone:
+44 (0)208 588 9131Website:
https://www.advanzpharma.comMedical Information Direct Line:
+353 1800 851 119Customer Care direct line:
+353 1 5294 230