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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dalbavancina Accord 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, as 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 Accord is and what it is used for
2. What you need to know before using Dalbavancina Accord
3. How to use Dalbavancina Accord
4. Possible side effects
5. How to store Dalbavancina Accord
6. Contents of the pack and other information

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

Dalbavancina Accord contains the active substance dalbavancin, which is an antibiotic of 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 using Dalbavancina Accord

Do not use Dalbavancina Accord 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 receiving dalbavancin:

• 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 with this type of antibiotic may cause redness of the upper body, hives, itching, or skin rash. If you experience such reactions, your doctor may decide to interrupt or slow down the infusion.

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.

Use of Dalbavancina Accord with other medicines

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 an unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You and your doctor will decide whether you should be given dalbavancin.

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

Driving and using machines

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

Dalbavancina Accord contains sodium

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

3. How to use Dalbavancin Accord

Dalbavancin will be administered by a doctor or nurse.

• Adults: dalbavancin is given either as a single dose of 1,500 mg or as two doses 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 given 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 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 of age will be calculated by the doctor based on the child's age and weight.

Dalbavancin will be administered through an intravenous infusion (into a vein) 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 Dalbavancin Accord 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 Dalbavancin Accord

Inform your doctor or nurse immediately if you are concerned about missing the 2nd 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 will experience 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; drop in blood pressure; difficulty swallowing and/or difficulty breathing. These may be signs of a hypersensitivity reaction and could 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 or watery diarrhoea. The 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 adverse effects have also been reported with the use of dalbavancin.

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 levels in blood), increased platelet count in blood (thrombocytosis), increased blood count of a type of white blood cells 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 (an enzyme found in the body)
• Itching, urticaria
• Genital itching (women)
• Pain, redness or swelling at the site where the infusion was administered
• Feeling of warmth
• Increased levels of gamma-glutamyltransferase (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 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalbavancina Accord

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

This medicine does not require special storage conditions, provided it remains closed in its original container.

The prepared Dalbavancina Accord infusion solution must not be used if particles are present or if the solution is cloudy.

Dalbavancina Accord 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 containers you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Dalbavancina Accord

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.

After reconstitution, each ml of concentrate contains 20 mg of dalbavancin.

The diluted solution for infusion must have a final concentration of 1 to 5 mg/ml of dalbavancin.

• The other components are mannitol (E421), lactose monohydrate, concentrated hydrochloric acid and/or sodium hydroxide (only for pH adjustment).

Appearance of the product and contents of the container

Dalbavancina Accord powder for concentrate for solution for infusion is supplied in a 50 ml glass vial with a green flip-off seal. The vial contains white to off-white or pale yellow powder.

It is available in packs containing 1 vial.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10

08970 Sant Joan Despí, Barcelona,

Spain

Date of the most recent review of this summary: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Important: Consult the product's summary of product characteristics before prescribing this medicine.

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

Vials of Dalbavancina Accord are for single use only.

Instructions for reconstitution and dilution

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

1. The contents of each vial must be reconstituted by slowly adding 25 ml of water for injection.
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 must be a clear, colorless to yellow solution, free from visible particles.
5. The reconstituted concentrate must be diluted with 50 mg/ml (5%) glucose infusion solution.
6. To dilute the reconstituted concentrate, the 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 infusion solution. For example: 25 ml of 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, free from visible particles.
9. If particles or discoloration are observed, the solution must be discarded.

Dalbavancin 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 dalbavancin concentrate has only been established with 50 mg/ml (5%) glucose infusion solution.

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

Use in the paediatric population

For paediatric patients, the dose of dalbavancin 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 and based on the child's weight, from the vial to an intravenous bag or bottle containing 50 mg/ml (5%) glucose infusion solution. The diluted solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.

Table 1 below provides guidance 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 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 be within 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 (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

Dispose of any unused 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.