Xydalba 500 mg powder for concentrate for solution for infusion

Paediatric indication 

Paediatric indication 

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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

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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.

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.

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