DALBAVANCIN ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Dalbavancina Accord

Do not use Dalbavancina Accordif you are allergicto dalbavancina or 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:

• 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 medicine 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 give this medicine to children under 3 months. The effects of using dalbavancina in children under 3 months have not been sufficiently studied.

Using Dalbavancina Accord with other medicines

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

Pregnancy and breastfeeding

Dalbavancina 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 are planning to have a baby, ask your doctor for advice before taking this medicine. You and your doctor will decide if you should be given dalbavancina.

It is not known whether dalbavancina passes into human breast milk. Ask your doctor for advice before breastfeeding your baby. You and your doctor will decide if you should be given dalbavancina. You should not breastfeed while taking dalbavancina.

Driving and using machines

Dalbavancina may cause dizziness. Be careful when driving vehicles or using machines after you have been given this medicine.

Dalbavancina Accord contains sodium

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

3. How to use Dalbavancina Accord

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

• Adults:dalbavancina is administered in a single dose of 1,500 mg or in two doses with a week's difference: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6 to less than 18 years:dalbavancina is administered in a single dose of 18 mg/kg (maximum 1,500 mg).

• Young children and children from 3 months to less than 6 years:dalbavancina 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 will be calculated by the doctor based on the child's age and weight.

You will be given dalbavancina 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 dalbavancina in children with chronic kidney problems.

If you are given more Dalbavancina Accord than you should

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

If you miss a dose of Dalbavancina Accord

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

If you have any other questions about the use of this medicine, 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 life-threatening. 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 stop takingmedicines that stop or reduce bowel movement. Intestinal infection has been reported as an uncommon side effect. It can affect 1 in 100 people.

Other side effects that have been reported due to the use of dalbavancina are listed below.

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

Common -may affect up to 1 in 10 people:

• Headache
• Feeling sick (nausea)
• 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 blood (thrombocytosis), increased 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
• 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 warmth
• 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 they are 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 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 which is stated on the vial after EXP/CAD. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions if it is kept in its original packaging.

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

Dalbavancina Accord 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 of Dalbavancina Accord

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

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

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

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

Appearance of the product and pack contents

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

It is available in packs containing 1 vial.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10

08970 Sant Joan Despí, Barcelona,

Spain

Date of last revision of this leaflet: March 2024

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

This information is intended only for healthcare professionals:

Important:Consult the technical data sheet of the product before prescribing this medicine.

Dalbavancina Accord must be reconstituted with sterile water for injections and subsequently diluted with a 5% glucose solution for infusion.

The 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 dalbavancina.

1. The contents of each vial should be reconstituted by slowly adding 25 ml of water for injections.
2. Do not shake.To avoid foam formation, 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 dalbavancina.
4. The reconstituted concentrate must be a clear solution, colorless to yellow, 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 should be transferred from the vial to an intravenous bag or bottle containing the 5% glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg of dalbavancina.
7. After dilution, the infusion solution should have a final concentration of 1 to 5 mg/ml of dalbavancina.
8. The infusion solution must be a clear solution, colorless to yellow, without visible particles.
9. If particles or discoloration are identified, the solution should be discarded.

Dalbavancina 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. The compatibility of the reconstituted dalbavancina concentrate has only been established with a 5% glucose solution for infusion.

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

Use in the pediatric population

For pediatric patients, the dose of dalbavancina 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 dalbavancina 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 should have a final concentration of 1 to 5 mg/ml of dalbavancina.

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 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 dalbavancina.

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.

Table 1. Preparation of dalbavancina (final infusion concentration 2 mg/ml or 5 mg/ml for administration via syringe pump) in pediatric patients 3 to 12 months (dose 22.5 mg/kg)

Disposal

Discard any remaining reconstituted solution that is not used.

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