Dalbavancin Zentiva 500 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dalbavancina Zentiva 500 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Dalbavancina Zentiva is and what it is used for
2. What you need to know before being administered Dalbavancina Zentiva
3. How Dalbavancina Zentiva is administered
4. Possible side effects
5. How to store Dalbavancina Zentiva
6. Contents of the pack and other information

1. What Dalbavancina Zentiva is and what it is used for

Dalbavancina Zentiva contains the active substance dalbavancin, which is an antibiotic belonging to the glycopeptide group.

Dalbavancin is used to treat skin and soft tissue infections (tissue beneath the skin) in adults and children from birth.

Dalbavancin works by killing certain bacteria that can cause serious 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 additional antibiotics along with dalbavancin.

2. What you need to know before Dalbavancina Zentiva is administered to you

Do not use Dalbavancina Zentiva if you are allergic to dalbavancin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with 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 allergic to other antibiotics such as vancomycin or teicoplanin.

Diarrhea during or after treatment

If you develop diarrhea during or after your treatment, contact your doctor immediately.

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

Infusion-related reactions

Intravenous infusion of this type of antibiotic may cause redness of the upper body, hives, itching, and/or skin rashes. If you experience such reactions, your doctor may decide to interrupt the infusion or slow down the infusion rate.

Other infections

The use of antibiotics may sometimes lead to the development of a new and different infection. If this occurs, your doctor will decide on the appropriate course of action.

Other medicines and Dalbavancina Zentiva

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

Pregnancy and breastfeeding

Dalbavancin is not recommended during pregnancy unless clearly necessary, as it is unknown what effect it may have on the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine. You and your doctor will decide whether dalbavancin should be administered.

It is unknown whether dalbavancin passes into human breast milk. Consult your doctor before breastfeeding. You and your doctor will decide whether dalbavancin should be administered. You must not breastfeed while receiving dalbavancin.

Driving and using machines

Dalbavancina may cause dizziness. Exercise caution when driving or operating machinery after receiving this medicine.

Dalbavancina Zentiva contains sodium

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

3. How Dalbavancina Zentiva is administered

Dalbavancina Zentiva will be administered by a doctor or nurse.

• Adults: dalbavancin is administered either as a single 1,500 mg dose or as two doses given one week apart: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6 to less than 18 years of age: dalbavancin is administered as a single dose of 18 mg/kg (maximum 1,500 mg).
• Young children and children from 0 to less than 6 years of age: dalbavancin is administered as a single dose of 22.5 mg/kg (maximum 1,500 mg).

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

Dalbavancin will be given to you via an intravenous infusion, delivered through a drip directly into your bloodstream over 30 minutes.

Patients with chronic kidney problems

If you have chronic kidney problems, your doctor may decide to reduce your dose. There is insufficient information available to recommend the use of dalbavancin in children with chronic kidney problems.

If you are given more Dalbavancina Zentiva than you should

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

If you miss a dose of Dalbavancina Zentiva

Inform your doctor or nurse immediately if you are concerned about missing the second dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Serious adverse effects

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

• Sudden swelling of the lips, face, throat or tongue; severe rash; itching; tightness in the throat; 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 adverse effect. It may affect up to 1 in 1,000 people.
• Abdominal (stomach) pain and/or watery diarrhoea. Symptoms may be severe or persistent, and stools may contain blood or mucus. These may be signs of a bowel infection. In this situation, you must stop taking medicines that slow down or reduce intestinal movement. Bowel infection has been reported as an uncommon adverse effect. It may affect up to 1 in 100 people.
• Changes in hearing ability. These have been reported as an adverse effect with a similar medicine. Frequency is unknown. It is not possible to estimate the frequency from the available data.

The following are other adverse effects reported with Dalbavancin Zentiva.

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

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

• Headache
• Feeling unwell (nausea)
• Diarrhoea

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

• Vaginal infections, fungal infections, oral candidiasis
• Urinary tract infections
• Anaemia (low red blood cell count), increased platelet count in blood (thrombocytosis), increased blood 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
• Decreased appetite
• Difficulty sleeping
• Dizziness
• Change in taste sensation
• Inflammation and swelling of superficial veins, hot flushes
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase levels (an enzyme found in the body)
• Itching, urticaria
• Genital itching (women)
• Pain, redness, or swelling at the infusion site
• Feeling of warmth
• Increased blood levels of 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 adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificarRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalbavancin Zentiva

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

Do not use this medicine after the expiry date stated on the vial after EXP.

The expiry date refers to the last day of the month indicated.

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

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

This medicine does not require special storage conditions if kept closed in its original container.

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

Dalbavancin Zentiva is for single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dalbavancin Zentiva

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

Appearance of the product and contents of the pack

Dalbavancin Zentiva powder for concentrate for solution for infusion is supplied in a 50 ml glass vial with a grey bromobutyl stopper and sealed with an aluminum seal and green flip-off cap. The vial contains white or off-white to pale yellow powder or compacted 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 European Economic Area member states 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 the most recent review of this summary: October 2025

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

This information is intended for healthcare professionals only:

Important: Consult the Product Information before prescribing this medicinal product.

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

Dalbavancin Zentiva vials are for single use only.

Instructions for reconstitution and dilution

An aseptic technique must be used for the reconstitution and dilution of Dalbavancin Zentiva.

1. The contents of each vial must be reconstituted by slowly adding 25 ml of water for injections.
2. Do not shake. To avoid foaming, gently swirl and invert the vial alternately until the contents are completely dissolved. Reconstitution may take up to 5 minutes.
3. The reconstituted concentrate in the vial contains 20 mg/ml of dalbavancin.
4. The reconstituted concentrate should be a clear, colourless to yellow solution, free from visible particles.
5. The reconstituted concentrate must be diluted with 50 mg/ml (5%) glucose solution for infusion.
6. To dilute the reconstituted concentrate, an appropriate volume of the 20 mg/ml concentrate should 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 concentrate contains 500 mg of dalbavancin.
7. After dilution, the infusion solution should have a final concentration of 1 to 5 mg/ml of dalbavancin.
8. The infusion solution should be a clear, colourless to yellow solution, free from visible particles.
9. If particles or discoloration are observed, the solution must be discarded.

Dalbavancin 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. Compatibility of the reconstituted concentrate of Dalbavancin Zentiva 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 Dalbavancin Zentiva, the line must be flushed before and after each Dalbavancin Zentiva infusion with 5% glucose solution for infusion.

Use in the paediatric population

For paediatric patients, the dose of Dalbavancin Zentiva will vary depending on the child's age and weight, up to a maximum of 1,500 mg. Transfer the required dose of 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 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 paediatric patients from birth to 12 months of age weighing 1 to 12 kg. Alternative concentrations may be prepared, but 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 for each age group, but may be used to estimate the approximate volume to verify the calculation.

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

Disposal

Discard any unused portion of the reconstituted solution.

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