XYDALBA 500 mg POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

2. What you need to know before you are given Xydalba

Do not use Xydalbaif you are allergicto dalbavancin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start receiving Xydalba:

• If you have or have had kidney problems. Depending on your age and kidney function, your doctor may need to reduce your dose.
• If you have diarrhea, or have had diarrhea in the past when treated with antibiotics.
• If you are allergicto other antibiotics such as vancomycin or teicoplanin.

Diarrhea during or after treatment

If you have diarrhea duringor afteryour treatment, contact your doctor immediately.

Do not take any medicine to treat diarrhea without first talking to your doctor.

Infusion-related reactions

Intravenous infusion with this type of antibiotic can cause redness of the upper body, hives, itching, or skin rashes. If you experience this type of reaction, your doctor may decide to interrupt or slow down the infusion.

Other infections

The use of antibiotics can sometimes cause a new and different infection to appear. If this happens, your doctor will decide what to do.

Other medicines and Xydalba

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Xydalba is not recommended during pregnancy unless clearly necessary, as it is not known what effect it could have on the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before you are given this medicine. You and your doctor will decide if you will be given Xydalba.

It is not known if Xydalba passes into breast milk in humans. Talk to your doctor before breastfeeding your baby. You and your doctor will decide if you will be given Xydalba. You should not breastfeed while taking Xydalba.

Driving and using machines

Xydalba may cause dizziness. Be careful when driving or using machines after you have been given this medicine.

Xydalba contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How Xydalba is given

Xydalba will be given to you by a doctor or nurse.

• Adults: Xydalba is given as a single dose of 1,500 mg or in two doses with a week's difference: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6to less than 18years: Xydalba is given as a single dose of 18 mg/kg (maximum 1,500 mg).
• Young children and children from 0to less than 6years: Xydalba is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children from 0 to less than 18 years will be calculated by the doctor based on the child's age and weight.

You will be given Xydalba through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.

Patients with chronic kidney problems

If you have chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of Xydalba in children with chronic kidney problems.

If you are given more Xydalba than you should

Tell your doctor or nurse immediately if you think you may have been given too much Xydalba.

If you miss a dose of Xydalba

Tell your doctor or nurse immediately if you are concerned that you may miss the 2nd dose.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you have any of these symptoms - you may need urgent medical attention:

• Sudden swelling of the lips, face, throat, or tongue; severe rash; itching; difficulty swallowing or breathing; low blood pressure.These can be signs of a hypersensitivity reaction and can be life-threatening. This reaction has been reported as a rare side effect.
• Abdominal pain (stomach)or watery diarrhea. The symptoms can be severe or may not go away, and the stools may contain blood or mucus. These can be signs of an intestinal infection. In this situation, you should stoptaking medicines that stop or slow down bowel movements. Intestinal infection has been reported as an uncommon side effect.
• Changes in hearing. These have been reported with a similar medicine. The frequency is unknown. It is not possible to estimate the frequency from the available data.

Other side effects that have been reported with Xydalba are listed below.

Talk to your doctor, pharmacist, or nurse if you have any of the following side effects:

Common – (may affect up to 1 in 10 people):

• Headache
• Feeling sick (nausea)
• Diarrhea

Uncommon – (may affect up to 1 in 100 people):

• Vaginal infections, fungal infections, oral thrush
• Urinary tract infections
• Anemia (low red blood cell count), high platelet count, increased eosinophil count, low white blood cell count
• Changes in other blood tests
• Loss of appetite
• Difficulty sleeping
• Dizziness
• Change in taste
• Inflammation and swelling of superficial veins, flushing
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase (an enzyme found in the body)
• Itching, hives
• Genital itching (women)
• Pain, redness, or swelling at the infusion site
• Feeling of warmth
• Increased gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare – (may affect up to 1 in 1,000 people):

• Difficulty breathing (bronchospasm)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xydalba

Keep this medicine out of the sight and reach of children.

Do notuse this medicine after the expiry date which is stated on the vial after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions if kept in the original package.

Do not use the Xydalba solution for infusion if you notice any particles or the solution is cloudy.

Xydalba is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Xydalba Composition

• The active ingredient is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
• The other components are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (only for pH adjustment).

Product Appearance and Container Content

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 or off-white to light yellow powder.

It is available in packs containing 1 vial.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate,

Dundalk,

Co. Louth, A91 P9KD, Ireland

Almac Pharma Services Ltd

Seagoe Industrial Estate, Craigavon,

County Armagh BT63 5UA

United Kingdom

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22

60131 Ancona

Italy

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet {MM/YYYY}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Important:Consult the summary of product characteristics or package leaflet before prescribing this medicinal product.

Xydalba must be reconstituted with sterile water for injection and subsequently diluted with a 50 mg/ml (5%) glucose solution for infusion.

Xydalba vials are for single use only.

Reconstitution and Dilution Instructions

Aseptic technique must be used for the reconstitution and dilution of Xydalba.

1. The contents of each vial must be reconstituted by slowly adding 25 ml of water for injectable preparations.
2. Do not shake.To avoid foam formation, gently swirl and invert the vial until the contents are completely dissolved. The reconstitution time may be up to 5 minutes.
3. The reconstituted concentrate in the vial contains 20 mg/ml of dalbavancin.
4. The reconstituted concentrate must be a clear, colorless to yellow solution without visible particles.
5. The reconstituted concentrate must be diluted with a 50 mg/ml (5%) glucose solution for infusion.
6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/ml concentrate must be transferred from the vial to an intravenous bag or bottle containing a 50 mg/ml (5%) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg of dalbavancin.
7. After dilution, the infusion solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.
8. The infusion solution must be a clear, colorless to yellow solution without visible particles.
9. If particles or color changes are identified, the solution must be discarded.

Xydalba must not be mixed with other medicinal products or intravenous solutions. Solutions containing sodium chloride may cause precipitation and MUST NOT be used for reconstitution or dilution. The compatibility of the reconstituted Xydalba concentrate has only been established with a 50 mg/ml (5%) glucose solution for infusion.

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

Use in the Pediatric Population

For pediatric patients, the dose of Xydalba will vary depending on the age and weight of the child up to a maximum of 1,500 mg. Transfer the required dose of the reconstituted dalbavancin solution, according to the instructions above, based on the child's weight, from the vial to an intravenous bag or bottle containing a 50 mg/ml (5%) glucose solution for infusion. The diluted solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.

Table 1 below provides information for preparing an infusion solution with a final concentration of 2 mg/ml or 5 mg/ml (sufficient in most cases), to be administered via a syringe pump, to achieve a dose of 22.5 mg/kg in pediatric patients from birth to 12 months of age with a weight of 1 to 12 kg. Alternative concentrations can be prepared, but they must have a final concentration range of 1 to 5 mg/ml of dalbavancin.

Refer to Table 1 to confirm calculations. The values shown are approximate. Note that the table does NOT include all possible calculated doses in each age group, but it can be used to estimate the approximate volume for verification of the calculation.

Table 1. Preparation of Xydalba (final infusion concentration 2 mg/ml or 5 mg/ml for administration via syringe pump) in pediatric patients from birth to 12 months (dose of 22.5 mg/kg)

Disposal

Discard any unused portion of the reconstituted solution.

Disposal of unused medicinal products and all materials that have come into contact with them must be carried out in accordance with local regulations.