DALBAVANCIN BAXTER 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

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

Do not use Dalbavancina Baxterif you are allergicto dalbavancina or to 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 Dalbavancina Baxter:

• If you have or have had kidney problems. Depending on your age and the condition of your kidney, 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 allergic to 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 rashes. 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 Baxter in children under 3 months have not been sufficiently studied.

Other medicines and Dalbavancina Baxter

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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You and your doctor will decide if you will be given this medicine.

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

Driving and using machines

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

Dalbavancina Baxter contains sodium

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

3. How to use Dalbavancina Baxter

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

• Adults: this medicine is administered in a single dose of 1500 mg or in two doses with a week's difference: 1000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6 years to less than 18 years: this medicine is administered in a single dose of 18 mg/kg (maximum 1500 mg).
• Young children and children from 3 months to less than 6 years: this medicine is administered in a single dose of 22.5 mg/kg (maximum 1500 mg).

Your doctor will calculate the dose for children from 3 months to less than 18 years based on the child's age and weight.

This medicine will be administered to you 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 Baxter than you should

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

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 Baxter

Tell your doctor or nurse immediately if you are concerned that you may miss the second 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; severe 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 severe reaction has been reported as a rare side effect. It can affect 1 in 1000 people.
• Abdominal pain (stomach pain) 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 should stop taking medicines 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 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 have any of the following side effects:

Common- may affect up to 1 in 10 people:

• Headache
• Feeling unwell (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, hot flashes
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase (enzyme found in the body)
• Itching, hives
• Genital itching (women)
• Pain, redness, or swelling at the infusion site
• Feeling of heat
• Increased gamma-glutamyltransferase (enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare- may affect up to 1 in 1000 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalbavancina Baxter

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

Do notuse this medicine after the expiry date which is stated on the vial after 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.

Chemical and physical stability has been demonstrated for 48 hours at 25°C and 2-8°C, for both the reconstituted concentrate and the diluted solution.

From a microbiological point of view, the medicine should be used immediately. Otherwise, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2 and 8°C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Do not use the Dalbavancina Baxter solution for infusion if you notice any particles or if the solution is cloudy.

Dalbavancina Baxter 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. Container Content and Additional Information

Composition of Dalbavancin Baxter

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

Appearance of the Product and Container Content

Dalbavancin Baxter powder for concentrate for solution for infusion EFG is provided in a 53 ml clear glass vial for single use with a chlorobutyl rubber stopper and a red aluminum seal. The vial contains powder ranging in color from white to off-white or light yellow.

It is available in cardboard boxes containing 1 vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BAXTER HOLDING B.V.

Kobaltweg 49, 3542 CE

Utrecht, Netherlands

Manufacturer

Famar Health Care Services Madrid S.A.U,

Avenida de Leganés, 62, Poligono Industrial Urtinsa I,

28923 Alcorcón, Madrid, Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Baxter, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Germany Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion

Austria Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion

Denmark Dalbavancin Baxter

Spain Dalbavancina Baxter 500 mg powder for concentrate for solution for infusion EFG

France Dalbavancine Baxter 500 mg powder for solution for infusion

Finland Dalbavancin Baxter 500 mg dry substance for intermediate concentrate for infusion solution, solution

Italy Dalbavancina Baxter

Sweden Dalbavancin Baxter 500 mg powder for concentrate for infusion solution, solution.

Date of the last revision of this prospectus:May 2024

Detailed information about 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 technical data sheet before prescribing this medication.

Dalbavancin Baxter 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 Dalbavancin Baxter are for single use.

Instructions for reconstitution and dilution

An aseptic technique must be used for the reconstitution and dilution of Dalbavancin Baxter.

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 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 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 a 50 mg/ml (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 Baxter 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. Compatibility of the reconstituted Dalbavancin Baxter 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 Dalbavancin Baxter, the line must be flushed before and after each Dalbavancin Baxter infusion with a 5% glucose solution for infusion.

Use in the pediatric population

For pediatric patients, the dose of Dalbavancin Baxter will vary depending on the age and weight of the child up to a maximum of 1500 mg. Transfer the required dose of the reconstituted dalbavancin 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 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 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 could be used to estimate the approximate volume to verify the calculation.

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

Elimination

Discard any unused portion of the reconstituted solution.

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