DALBAVANCIN TEVA 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Dalbavancina Teva 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dalbavancina Teva and what is it used for
2. What you need to know before you use Dalbavancina Teva
3. How to use Dalbavancina Teva
4. Possible side effects
5. Storage of Dalbavancina Teva
6. Contents of the pack and other information

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

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

Dalbavancin is used to treat skin and soft tissue infections (tissue under the skin) in adults and children 3 months or 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 also have other bacteria that cause the infection, your doctor may decide to treat you with other antibiotics in addition to dalbavancin.

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

Do not use Dalbavancina Tevaif you are allergicto dalbavancin or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start receiving dalbavancin:

• 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, and/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.

Other medicines and Dalbavancina Teva

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 dalbavancin passes into breast milk in humans. 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 or using machines after you have been given this medicine.

Dalbavancina Teva 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 Teva

Dalbavancina will be given 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 too much Dalbavancina Teva

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Dalbavancina Teva

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

If you have any further questions on 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; severe rash; itching; 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)and/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.
• Changes in hearing.These have been reported with a similar medicine. 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 of dalbavancina are 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
• 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 the 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, hot flushes
• 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:

• Breathing difficulties (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 Teva

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

Do notuse this medicine after the expiry date which is stated on the carton and on the vial after EXP/CAD. The expiry date is the last day of the month stated.

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

The chemical and physical stability of Dalbavancina Teva has been demonstrated for both the reconstituted concentrate and the diluted solution for 48 hours at 25 °C and at 2-8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally no longer than 24 hours at 2 to 8 °C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

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

Dalbavancina Teva is for single use.

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. Container Contents and Additional Information

Dalbavancina Teva Composition

• The active ingredient is dalbavancina. Each vial of powder contains dalbavancina hydrochloride equivalent to 500 mg of dalbavancina.
• The other components are mannitol (E421), lactose monohydrate, hydrochloric acid 1N and/or sodium hydroxide 1N (only for pH adjustment).

Product Appearance and Container Contents

Dalbavancina Teva powder for concentrate for solution for infusion is provided in a 53 ml transparent glass vial with a chlorobutyl plug and a red aluminum seal cap. The vial contains a white to light yellow powder.

It is available in packs containing 1 vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva, B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

Manufacturer

Famar Health Care Services Madrid S.A.U

Avenida de Leganés, 62, Polígono Industrial Urtinsa I

28923 Alcorcón, Madrid.

Spain

Local Representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Date of Last Revision of this Leaflet:May 2024

Detailed and updated information on this medicinal product 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 for healthcare professionals only:

Important:Consult the product's technical sheet before prescribing this medication.

Dalbavancina Teva must be reconstituted with sterile water for injectable preparations and subsequently diluted with a 50 mg/ml (5%) glucose solution for infusion.

The vials of Dalbavancina Teva are for single use.

Reconstitution and Dilution Instructions

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

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 generating foam, gently agitate 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, colorless to yellow solution without visible particles.
5. The reconstituted concentrate must be diluted with a 50 mg/ml (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 the 50 mg/ml (5%) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg of dalbavancina.
7. After dilution, the infusion solution must have a final concentration of 1 to 5 mg/ml of dalbavancina.
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.

Dalbavancina 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 dalbavancina concentrate has only been established with a 50 mg/ml (5%) glucose solution for infusion.

If a common intravenous line is used to administer other medications in addition to dalbavancina, the line must 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 depending on the age and weight of the child up to a maximum of 1,500 mg. Transfer the required dose of the reconstituted dalbavancina solution, according to the previous instructions, based on the child's weight, from the vial to an intravenous bag or bottle containing a 50 mg/ml (5%) glucose solution for infusion. The diluted solution must have a final concentration of 1 to 5 mg/ml of dalbavancina.

Table 1 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 Table 1 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 concentration for infusion 2 mg/ml or 5 mg/ml to be administered via syringe pump) in pediatric patients 3 to 12 months (dose of 22.5 mg/kg)

Elimination

Discard any remaining reconstituted solution that is not used.

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