DALBAVANCINA ZENTIVA 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you are given Dalbavancina Zentiva

Do not use Dalbavancina Zentivaif 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 Dalbavancina Zentiva:

• 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 previously had diarrhea when treated with antibiotics.
• If you are allergicto other antibiotics such as vancomycin or teicoplanin.

Diarrhea during or after treatment

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

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

Infusion-related reactions

Intravenous infusion with this type of antibiotic can cause redness of the upper body, hives, itching, and/or skin rash. 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 the appearance of a new and different infection. If this happens, your doctor will decide what to do.

Children

Do not give this medicine to children under 3 months. The effects of using dalbavancin in children under 3 months have not been sufficiently studied.

Other medicines and Dalbavancina Zentiva

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

Pregnancy and breastfeeding

Dalbavancin 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 are planning to have a baby, ask your doctor for advice before taking this medicine. You and your doctor will decide if you should be given dalbavancin.

It is not known whether dalbavancin passes into breast milk in humans. Ask your doctor for advice before breastfeeding your baby. You and your doctor will decide if you should be given dalbavancin. You should not breastfeed while taking dalbavancin.

Driving and using machines

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

Dalbavancina Zentiva contains sodium

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

3. How Dalbavancina Zentiva is given

Dalbavancina Zentiva will be given to you by a doctor or nurse.

• Adults: dalbavancin 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 6 years to less than 18 years:dalbavancin is given as a single dose of 18 mg/kg (maximum 1,500 mg).
• Young children and children from 3 months to less than 6 years:dalbavancin is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).

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

You will be given dalbavancin 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 dalbavancin in children with chronic kidney problems.

If you are given more Dalbavancina Zentiva than you should

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

If you miss a dose of Dalbavancina Zentiva

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

If you have any further questions on 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; throat tightness; low blood pressure; difficulty swallowing and/or difficulty breathing.These may be signs of a hypersensitivity reaction and can be life-threatening. This reaction has been reported as a rare side effect.It can affect up to 1 in 1,000 people.
• Abdominal pain (stomach)and/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 must stoptaking medicines that stop or reduce bowel movement. Intestinal infection has been reported as an uncommon side effect. It can affect up to 1 in 100 people.
• Changes in hearing. They 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 Dalbavancina Zentiva are listed below.

Talk to your doctor, pharmacist, or nurse if you get 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 in blood (thrombocytosis), increased count of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cells (leucopenia, neutropenia)
• 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 levels in blood (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

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

• Breathing difficulties (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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificarRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalbavancina Zentiva

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.

The physical and chemical stability of Dalbavancina Zentiva has been demonstrated for both the reconstituted concentrate and the diluted solution for 48 hours at or below 25 °C. The total in-use stability from reconstitution to administration should not exceed 48 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 and 8 °C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions. Do not freeze.

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

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

Dalbavancina Zentiva is for single use.

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

Dalbavancina Zentiva Composition

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
• The other ingredients are mannitol (E421), lactose monohydrate, 0.1M hydrochloric acid and/or 0.1M sodium hydroxide (only for pH adjustment).

Product Appearance and Container Content

Dalbavancina Zentiva powder for concentrate for solution for infusion is provided in a 50 ml glass vial with a grey bromobutyl stopper and sealed with an aluminium tear-off cap and green flip-off. The vial contains white or off-white to light yellow powder or compact powder.

It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, k.s.,

U kabelovny 130,

Prague 10 – Dolní Mecholupy,

102 37 Czech Republic

Manufacturer

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

San Agustin de Guadalix, 28750

Madrid – Spain

or

Galenicum Health, S.L.U.

Calle Sant Gabriel, 50

08950 Esplugues de Llobregat,

Barcelona – Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Malta: Dalbavancin Zentiva 500 mg powder for concentrate for solution for infusion

Germany: Dalbavancin Zentiva 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

France: DALBAVANCINE ZENTIVA 500 mg, poudre pour solution à diluer pour perfusion

Italy: Dalbavancina Zentiva

Spain: Dalbavancina Zentiva 500 mg polvo para concentrado para solución para perfusión EFG

Austria: Dalbavancin Zentiva 500 mg Pulver für ein Konzentrat zur Herstellung eine Infusionslösung

Sweden: Dalbavancin Zentiva

Date of last revision of this leaflet: July 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Important:Consult the Summary of Product Characteristics before prescribing this medicinal product.

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

The vials of Dalbavancina Zentiva are for single use.

Instructions for reconstitution and dilution

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

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, colourless 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 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, colourless to yellow solution without visible particles.
9. If particles or discoloration are identified, the solution must be discarded.

Dalbavancina Zentiva 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 Dalbavancina Zentiva concentrate has only been established with 50 mg/ml (5%) glucose solution for infusion.

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

Use in the Paediatric Population

For paediatric patients, the dose of Dalbavancina Zentiva 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 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 to prepare 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 paediatric patients from 3 to 12 months of age with a weight of 3 to 12 kg. Alternative concentrations can be prepared, but they must have a final concentration range of 1 to 5 mg/ml of dalbavancin.

Consult Table 1 to confirm the 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 Dalbavancina Zentiva (final infusion concentration 2 mg/ml or 5 mg/ml for administration via syringe pump) in paediatric patients from 3 to 12 months (dose of 22.5 mg/kg)

Disposal

Discard any unused portion of the reconstituted solution.

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