Xydalba 500 mg de polvo para concentrado para solucion para perfusion

Patient Information Leaflet

Xydalba 500 mg Powder for Concentrate for Solution for Infusion

Dalbavancin

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Xydalba contains the active substance dalbavancin, which is aantibioticin the group of glucopéptidos.

Xydalba is used to treatskin and soft tissue infections (tissue under theskin) in adults and children 3 months or older.

Xydalba acts by killing certain bacteria, which can cause severe infections. It kills bacteria by interfering with the formation of bacterial cell walls.

If you have other bacteria causing the infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.

Do not use Xydalbaif you areallergicto dalbavancina or any of the other components of thismedication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Xydalba:

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

Diarhea during or after treatment

If you developdiarrhea duringorafteryour treatment, contact your doctorimmediately.

Do not take any medication to treat diarrhea without consulting your doctor first.

Reactions related to infusion

The intravenous infusion of this type of antibiotic may cause flushing of the upper body, urticaria, itching, or skin rashes. If you experience these types of reactions, your doctor may decide to stop or slow down the infusion.

Other infections

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

Children

Do not administer this medication to children under 3 months. The effects of using Xydalba in children under 3 months have not been sufficiently studied.

Use of Xydalba with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

Xydalba is not recommended during pregnancy unless clearly necessary, as it is not known what effect it could have on an unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. You and your doctor will decide if Xydalba will be administered to you.

The passage of Xydalba into human breast milk is unknown. Consult your doctor before breastfeeding your baby. You and your doctor will decide if Xydalba will be administered to you. Do not breastfeed while taking Xydalba.

Driving and operating machines

Xydalba may cause dizziness. Be careful when driving vehicles and using machines after receiving this medication.

Xydalba contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, making it essentially “sodium-free”.

Xydalba will be administered by a doctor or nurse.

• Adults: Xydalba is administered in a single dose of 1,500 mg or in two doses with a one-week interval: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6years old to less than 18years old:Xydalba is administered in a single dose of 18mg/kg (maximum 1,500mg).
• Small children and children from 3months old to less than 6years old:Xydalba is administered in a single dose of 22.5mg/kg (maximum 1,500mg).

The dose for children from 3months old to less than 18years old will be calculated by the doctor based on the child's age and weight.

Xydalba will be administered to you through a catheter directly into your bloodstream through a vein (intravenous route) 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 more Xydalba is administered than it should

Inform your doctor or nurse immediately if you think you may have received too much Xydalba.

If you miss a dose of Xydalba

Inform your doctor or nurse immediately if you are concerned that you may have missed the second dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

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

• Swelling of the lips, face, throat, or tongue; intense itching; hives; throat constriction; low blood pressure; difficulty swallowing and/or breathing.These may be signs of an allergic reaction and can be fatal. This reaction has been reported as a rare side effect.It may affect 1 in 1,000 people.
• Abdominal pain (stomach)ordiarrhea.The symptoms may be severe ormay not go away and the stool may contain blood or mucus. These may be signs of an intestinal infection. In this situation, you shouldstoptaking medicines that slow or reduce intestinal movement. Intestinal infection has been reported as an infrequent side effect. It may affect 1 in 100 people.
• Changes in hearing ability. They have been reported as a side effect in asimilar medicine. The frequency is unknown. It is not possible to estimate the frequency from the available data.

The following other side effects have been reported due to the use of Xydalba.

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

Frequent -may affect up to 1 in 10 people:

• Headache
• Unpleasant sensation (nausea)
• Diarrhea

Infrequent -may affect up to 1 in 100 people:

• Vaginal infections, fungal infections, oral candidiasis
• Urinary tract infections
• Anemia (low red blood cell count), elevated platelet count in blood (thrombocytosis), increased white blood cell count of a type called eosinophils (eosinophilia), low counts of other types of white blood cells (leucopenia, neutropenia)
• Changes in other blood tests
• Loss of appetite
• Difficulty sleeping
• Dizziness
• Change in sense of taste
• Swelling and inflammation of superficial veins, hot flashes
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase (enzyme found in the body)
• Itching, urticaria
• Genital itching (women)
• Pain, redness, or swelling at the site where the infusion was administered
• Sensation of heat
• Increased levels of gamma-glutamyltransferase (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 side effects

If you experience any type ofside effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es..By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do notuse this medication after the expiration date that appears in the vial after CAD.

The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions if it is kept closed in its original packaging.

The Xydalba solution prepared for infusion should not be used if there are any particles or the solution is cloudy.

Xydalba is for single use.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Xydalba

• 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).

Appearance of the product and contents of the package

Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green stopper cap. The vial contains powder of color from white, off-white to light yellow.

It is available in packages containing 1 vial.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Responsible for manufacturing

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet 09/2022..

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Important:Consult the product data sheet before prescribing this medicine.

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

Xydalba vials are for single use only.

Instructions for reconstitution and dilution

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

1. The contents of each vial must be reconstituted by adding 25 ml of water for injection slowly.
2. Do not agitate.To avoid foam generation, alternate gentle agitation and vial inversion until the contents have 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 reconstituted concentrate of the appropriate volume of 20 mg/ml must be transferred from the vial to a intravenous bag or a container that contains a 50 mg/ml (5 %) glucose solution for infusion. For example: 25 ml of the reconstituted 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 discoloration are identified, the solution must be discarded.

Xydalba must not be mixed with other medications 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 route is used to administer other medications in addition to Xydalba, the route must be cleaned before and after each Xydalba infusion with a 5 % glucose solution for infusion.

Use in pediatric population

For pediatric patients, the Xydalba dose 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 a container that contains 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.

The table1 below provides information to prepare an infusion solution with a final concentration of 2mg/ml or 5mg/ml (sufficient in most cases), to be administered via a syringe pump, to achieve a dose of 22.5mg/kg in pediatric patients aged 3 to 12months weighing 3 to 12kg. Alternative concentrations may be prepared, but they must have a final concentration range of 1 to 5mg/ml of dalbavancin.

Consult table1 to confirm calculations. The values shown are approximate. Note that the tabledoes not include all possible calculated doses in each age group, but may be used to estimate the approximate volume to verify the calculation.

Table1. Preparation of Xydalba (final concentration for infusion 2mg/ml or 5mg/ml to be administered via syringe pump) in pediatric patients aged 3 to 12months (dose of 22.5mg/kg)

Elimination

Dispose of any unused reconstituted solution.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.