DALBAVANCIN SALA 500 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

2. What you need to know before you use Dalbavancin Sala

Do not useDalbavancin Salaif you are allergicto dalbavancin or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to receiveDalbavancin Sala:

• If you have or have had kidney problems. Depending on your age and kidney condition, your doctor may need to reduce your dose.

• If you suffer from 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 develop diarrhea duringor afteryour treatment, contact your doctor immediately.

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

Infusion-related reactions

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

Children

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

Other medications and Dalbavancin Sala

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

Pregnancy and breastfeeding

Dalbavancin is not recommended during pregnancy unless clearly necessary, because it is not known 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 medication. You and your doctor will decide if you will be given dalbavancin.

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

Driving and using machines

Dalbavancin may cause dizziness. Be careful when driving vehicles and using machines after being administered this medication.

Dalbavancin Salacontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to use Dalbavancin Sala

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

• Adults: dalbavancin is administered in a single dose of 1,500 mg or in two doses with a week apart: 1,000 mg on day 1 and 500 mg on day 8:
• • Children and adolescents from 6to less than 18years old:dalbavancin is administered in a single dose of 18 mg/kg (maximum 1,500 mg).
  • Young children and children from 3months to less than 6years old:dalbavancin is administered in a single dose of 22.5 mg/kg (maximum 1,500 mg).

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

You will be administered 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 moreDalbavancin Salathan you should

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

If you miss a dose ofDalbavancin Sala

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

If you have any other questions about using this medication, 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; intense rash; itching; throat tightness; low blood pressure; difficulty swallowing and/or difficulty breathing.These can be signs of a hypersensitivity reaction and can be fatal. This reaction has been reported as a rare side effect. It can affect 1 in 1,000 people.
• Abdominal pain (stomach)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 medications that stop or reduce bowel movement. Intestinal infection has been reported as an uncommon side effect. It can affect 1 in 100 people.
• Changes in hearing. They have been reported with a similar medication. The frequency is unknown. It is not possible to estimate the frequency from the available data.

Other side effects that have been reported due to the use ofdalbavancinare 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
• Nausea (feeling sick)
• 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 the blood (thrombocytosis), increased count of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cells (leukopenia, neutropenia)
• Changes in other blood tests
• Decreased 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 heat
• Increased 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dalbavancin Sala

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

Do not use this medication after the expiration date stated on the vial after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions if kept in its original packaging.

The prepared Dalbavancin Sala solution for infusion should not be used if there are any particles or if the solution is cloudy.

Dalbavancin Sala is for single use only.

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. Contents of the pack and other information

Composition ofDalbavancin Sala

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

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

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

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

Appearance and pack contents

Dalbavancin Sala powder for concentrate for solution for infusion is presented in a 50 ml glass vial with a green flip-off cap. The vial contains a white, off-white to light 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 medication is authorized in the Member States of the European Economic Area under the following names:

France: Dalbavancine Reig Jofre 500 mg powder for solution for infusion

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

Poland: Dalbavancin Reig Jofre

Sweden: Dalbavancin Bioglan

Date of last revision of this leaflet 03/2024.

Other sources of information

Detailed information on this medication 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 product's technical data sheet before prescribing this medication.

Dalbavancin Sala must be reconstituted with sterile water for injectable preparations and then diluted with a 5% glucose solution for infusion.

The vials of Dalbavancin Sala 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 sterile water for injectable preparations.
2. Do not shake.To avoid foaming, 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, colorless to yellow solution without visible particles.
5. The reconstituted concentrate must be diluted with a 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 a 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, colorless to yellow solution without visible particles.
9. If particles or discoloration are identified, the solution must be discarded.

Dalbavancin must not be mixed with other medications or intravenous solutions. Solutions containing sodium chloride may cause precipitation and MUST NOT be used for reconstitution or dilution. The compatibility of the reconstituted dalbavancin concentrate has only been established with a 5% glucose solution for infusion.

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

Use in the pediatric population

For pediatric patients, the dose of dalbavancin will vary based on the child's age and weight 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 a 5% glucose solution for infusion. The diluted solution must have a final concentration of 1 to 5 mg/ml of dalbavancin.

The table 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 pediatric 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 the table 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.

Table1. Preparation of dalbavancin (final infusion concentration 2mg/ml or 5mg/ml to be administered via syringe pump) in pediatric patients from 3 to 12months (dose of 22.5mg/kg)

Disposal

Discard any unused reconstituted solution.

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