Dalbavancin Sala 500 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

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

Read all of this leaflet carefully before you start using this medicine, as 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, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Dalbavancin Sala is and what it is used for
2. What you need to know before using Dalbavancin Sala
3. How to use Dalbavancin Sala
4. Possible adverse effects
5. How to store Dalbavancin Sala
6. Contents of the pack and other information

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

Dalbavancina Sala contains the active substance dalbavancin, which is a glycopeptide antibiotic.

Dalbavancin is used to treat skin and soft tissue infections (tissue beneath the skin) in adults and children 3 months of age and older.

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 starting to use Dalbavancina Sala

Do not use Dalbavancina Sala 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 to receive Dalbavancina Sala:

• 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, 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 lead to the development of a new and different infection. If this occurs, your doctor will decide on the appropriate course of action.

Children

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

Other medicines and Dalbavancina Sala

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 could have on an unborn baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 dalbavancin should be administered. You must not breastfeed while receiving dalbavancin.

Driving and use of machines

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

Dalbavancina Sala 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 Sala

Dalbavancin will be administered to you by a doctor or nurse.

• Adults: dalbavancin is administered as a single 1,500 mg dose or in 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 into a vein (intravenous route) over 30 minutes.

Patients with chronic renal impairment

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

If you are given more Dalbavancin Sala 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 Sala

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 1 in 1,000 people.
• Abdominal (stomach) pain or watery diarrhoea. Symptoms may be severe or persistent, and stools may contain blood or mucus. These may be signs of an intestinal infection. In this situation, you must stop taking medicines that slow or reduce intestinal movement. Intestinal infection has been reported as an uncommon adverse effect. It may affect 1 in 100 people.
• Changes in hearing ability. These have been reported as an adverse effect with a similar medicine. The 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 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
• Increase in alkaline phosphatase (an enzyme present in the body)
• Itching, urticaria
• Genital itching (women)
• Pain, redness or swelling at the site where the infusion was administered
• Feeling of warmth
• Increase in gamma-glutamyltransferase 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 adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Sala

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 if kept closed in its original packaging.

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

Dalbavancina Sala 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 will help protect the environment.

6. Contents of the pack and other information

Composition of Dalbavancina Sala

• 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 pack

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

It is available in packs containing 1 vial.

Marketing Authorization Holder

Laboratorio Reig Jofre S.A.

Gran Capitan, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10

08970 Sant Joan Despí, Barcelona

Spain

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

France: Dalbavancine Reig Jofre 500 mg powder for solution to be diluted for infusion

Spain: Dalbavancina Sala 500 mg powder for concentrate for solution for infusion EFG

Poland: Dalbavancin Reig Jofre

Sweden: Dalbavancin Bioglan

Date of the most recent review of this summary: 03/2024

Other sources of information

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's summary of product characteristics before prescribing this medicinal product.

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

Dalbavancina Sala vials 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 injections.
2. Do not shake. To avoid foaming, gently swirl and invert the vial alternately until the contents are completely dissolved. The reconstitution time 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 glucose 50 mg/ml (5%) 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 glucose 50 mg/ml (5%) solution for infusion. 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 glucose 50 mg/ml (5%) solution for infusion.

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 solution for infusion.

Use in the paediatric population

For paediatric patients, the dose of dalbavancin will vary according to 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 glucose 50 mg/ml (5%) 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 a syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients aged 3 to 12 months with a weight of 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 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 aged 3 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.