Dalbavancin Advanz Pharma 500 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dalbavancina Advanz Pharma 500 mg powder for concentrate for solution for infusion EFG

Read the entire 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dalbavancina Advanz Pharma is and what it is used for
2. What you need to know before you are given Dalbavancina Advanz Pharma
3. How Dalbavancina Advanz Pharma is administered
4. Possible adverse effects
5. How to store Dalbavancina Advanz Pharma
6. Contents of the pack and other information

1. What Dalbavancina Advanz Pharma is and what it is used for

Dalbavancina Advanz Pharma contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste.

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 Advanz Pharma is administered to you

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Dalbavancina Advanz Pharma:

• 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 Advanz Pharma

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

Pregnancy and breastfeeding

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

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 administered Dalbavancina Advanz Pharma. You must not breastfeed while receiving dalbavancin.

Driving and use of machines

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

Dalbavancina Advanz Pharma contains sodium

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

3. How Dalbavancina Advanz Pharma is administered

Dalbavancina 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 3 months 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 3 months 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 directly into your bloodstream via a vein over a period of 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 Advanz Pharma than you should have received

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

If you miss a dose of Dalbavancina Advanz Pharma

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 have 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 may 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 may not go away, and stools may contain blood or mucus. These may be signs of an intestinal infection. In this case, you should stop taking medicines that slow down or reduce intestinal movement. Intestinal 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 Dalbavancin Advanz Pharma.

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

Common – 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
• Increase in alkaline phosphatase (an enzyme found in the body)
• Itching, hives
• Genital itching (women)
• Pain, redness or swelling at the site where the infusion was administered
• Feeling of warmth
• Increase in gamma-glutamyl transferase levels (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 Dalbavancina Advanz Pharma

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.

This medicine does not require special storage conditions, provided it is kept closed in its original packaging.

Do not use the prepared Dalbavancina Advanz Pharma solution for infusion if you notice any particles or if the solution appears cloudy.

Dalbavancina Advanz Pharma is for single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Dalbavancina Advanz Pharma

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg 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 Advanz Pharma powder for concentrate for solution for infusion is supplied in a 50 ml glass vial, closed with a grey bromobutyl stopper and sealed with an aluminum cap and a green plastic flip-off cap. The vial contains a white, off-white or pale yellow powder or compacted powder.

It is available in packs containing 1 vial.

Marketing Authorization Holder

Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9,
D09 V504,
Ireland

Manufacturer

SAG Manufacturing, S.L.U.
Ctra. N-I, Km 36
San Agustín de Guadalix, 28750
Madrid – Spain

Or

Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 Esplugues de Llobregat
Barcelona - Spain

Local Representative

Advanz Pharma Spain S.L.U.
Paseo de la Castellana 135, 7th floor
28046 Madrid
Spain
Tel.: +34 900 834 889
[email protected]

Date of the most recent revision of this package leaflet: October 2025

Detailed information on this medicine 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's technical data sheet or summary of product characteristics before prescribing this medicine.

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

Dalbavancina Advanz Pharma vials are for single use only.

Instructions for reconstitution and dilution

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

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 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, colorless 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, 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 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, colorless to yellow solution, free from visible particles.

9. If particles or color changes are observed, the solution must be discarded.

Dalbavancina Advanz Pharma must not be mixed with other medicines 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 Dalbavancina Advanz Pharma has only been established with 50 mg/ml (5%) glucose solution for infusion.

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

Use in the pediatric population

For pediatric patients, the dose of Dalbavancina Advanz Pharma 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 solution for infusion. 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 pediatric patients from birth to 12 months of age weighing 3 to 12 kg. Alternative concentrations may be prepared, but must fall 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 calculations.

Table 1. Preparation of Dalbavancina Advanz Pharma (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.

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