Dalbavancin Baxter

Package leaflet: Information for the user

Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion

dalbavancin
Generic medicine
Read this leaflet carefully before this medicine is given to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Dalbavancin Baxter is and what it is used for
2. What you need to know before you are given Dalbavancin Baxter
3. How Dalbavancin Baxter is given
4. Possible side effects
5. How to store Dalbavancin Baxter
6. Contents of the pack and other information

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

Dalbavancina Baxter contains the active substance dalbavancina, which is an antibiotic belonging to the glycopeptide group.
Dalbavancina Baxter is used in adults and children aged 3 months and older for the treatment of skin infections or infections of the underlying layers of the skin.
This medicine works by killing certain bacteria that can cause serious infections. It kills these bacteria by interfering with the formation of the bacterial cell wall.
If other bacteria causing the infection are also present, your doctor may decide to treat the infection with additional antibiotics alongside Dalbavancina Baxter.

2. What you need to know before you are given Dalbavancin Baxter

Do not use Dalbavancin Baxter if you are allergic to dalbavancin or to any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given
Dalbavancin Baxter:

• If you have or have had kidney problems. Depending on your age and kidney function, your doctor may consider it necessary to reduce the dose.
• If you suffer from diarrhoea, or if you have previously experienced diarrhoea during antibiotic treatment.
• If you are allergic to other antibiotics such as vancomycin or teicoplanin.

Diarrhoea during or after treatment
If you develop diarrhoea during or after treatment, inform your doctor immediately. Do not take
any medicine for diarrhoea without first consulting your doctor.
Infusion-related reactions
Intravenous infusions of these types of antibiotics may cause flushing of the upper body, urticaria, itching and/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 promote the development of a new and different infection. If this occurs, contact your doctor, who will decide on the appropriate action.
Children
This medicine must not be administered to children under 3 months of age. The use of dalbavancin has not been sufficiently studied in children under 3 months of age.
Other medicines and Dalbavancin Baxter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Dalbavancin Baxter is not recommended during pregnancy unless strictly necessary. This is because the effect on the unborn baby is unknown. If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before you are given this medicine. Together with your doctor, you can decide whether to receive this medicine.
It is not known whether this medicine passes into human breast milk. Ask your doctor for advice before breastfeeding. Together with your doctor, you can decide whether to receive Dalbavancin Baxter. You must not breastfeed while receiving this medicine.
Driving and using machines
Dalbavancin Baxter may cause dizziness. Exercise caution when driving or operating machinery after receiving this medicine.
Dalbavancin Baxter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Dalbavancina Baxter is administered

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

• Adults: this medicine is given either as a single 1,500 mg dose or as two doses one week apart: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents aged 6 years to less than 18 years: this medicine is given as a single dose of 18 mg/kg (maximum 1,500 mg).
• Infants and children aged 3 months to less than 6 years: this medicine is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children aged 3 months to less than 18 years will be calculated by the doctor based on the child's age and weight.
This medicine will be administered to you as an intravenous infusion directly into the bloodstream through a vein over 30 minutes.

Patients with chronic kidney problems
If you have chronic kidney problems, your doctor may decide to reduce your dose. There is insufficient information to recommend the use of Dalbavancina Baxter in children with chronic kidney problems.

If you are given more Dalbavancina Baxter than you should
Immediately inform your doctor or nurse if you think you have been given too high a dose of Dalbavancina Baxter.

If you miss a dose of Dalbavancina Baxter
Immediately inform your doctor or nurse if you are concerned about not having received the second dose.

If you have any questions about how to use this medicine, consult 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 experience any of the symptoms listed below, as
they may require urgent medical attention:

• Sudden swelling of the lips, face, throat or tongue; severe rash; itching; feeling of suffocation; drop in blood pressure; difficulty swallowing and/or breathing. These may all be symptoms of a hypersensitivity reaction and may be life-threatening. This serious reaction has been reported as a rare side effect. It may affect up to 1 in 1,000 people.
• Abdominal pain (stomach ache) and/or watery diarrhoea. Symptoms may become severe or may not go away, and stools may contain blood or mucus. These may be signs of a bowel infection. In this case, do not take medicines that stop or slow down bowel movement. Bowel infections have been reported as an uncommon side effect. They may affect up to 1 in 100 people.
• Changes in hearing. This has been reported as a side effect with a similar medicine. The frequency is unknown. The frequency cannot be estimated from the available data.

Other side effects reported with dalbavancin are listed below.
Contact your doctor, pharmacist, or nurse if you experience any of the following side effects:
Common – 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 thrush
• Urinary tract infections
• Anaemia (low red blood cell count), increased platelet count (thrombocytosis), increased blood levels of a type of white blood cells called eosinophils (eosinophilia), low levels of other types of white blood cells (leucopenia, neutropenia)
• Changes in other blood parameters
• Loss of appetite
• Sleep disorders
• 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, hives
• Genital itching (in females)
• Pain, redness or swelling at the infusion site
• Feeling of warmth
• Increased blood levels of gamma-glutamyl transferase (an enzyme produced by liver tissue and other body tissues)
• Rash
• Feeling unwell (vomiting)

Rare – may affect up to 1 in 1,000 people:

• Breathing difficulties (bronchospasm)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dalbavancin Baxter

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and vial after
Exp. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions when kept closed in the
original container.
Chemical and physical in-use stability of Dalbavancin Baxter 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 standpoint, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.
The Dalbavancin Baxter solution prepared for infusion must not be used if particulate matter is present or if the solution is cloudy.
Dalbavancin Baxter is a single-use medicinal product.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dalbavancina Baxter contains

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

Description of the appearance of Dalbavancina Baxter and contents of the pack
Dalbavancina Baxter powder for concentrate for solution for infusion is supplied in a single-use
clear glass vial of 53 mL with a chlorobutyl stopper and a red tear-off seal. The
vial contains a powder ranging in colour from white to off-white to pale yellow.
It is available in cardboard packs containing 1 vial.
Marketing Authorisation Holder and Manufacturer
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht, The Netherlands
Manufacturer
Famar Health Care Services Madrid S.A.U
Avenida de Leganés, 62,
Poligono Industrial Urtinsa I
28923 Alcorcón, Madrid,
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
AT Dalbavancin Baxter 500 mg Powder for a concentrate for solution for infusion
DE Dalbavancin Baxter 500 mg Powder for a concentrate for solution for infusion
ES Dalbavancina Baxter 500 mg powder for concentrate for perfusion solution EFG
FR Dalbavancine Baxter 500 mg powder for solution for perfusion
FI Dalbavancin Baxter 500 mg dry substance for intermediate concentrate for infusion solution, solution
IT Dalbavancina Baxter
SE Dalbavancin Baxter 500 mg powder for concentrate for infusion solution, solution.
The following information is intended exclusively for physicians or healthcare professionals:
Important: please consult the Summary of Product Characteristics (SmPC) before prescribing.
Dalbavancina Baxter must be reconstituted with sterile water for injections and subsequently diluted with 5% glucose solution for infusion (50 mg/mL).
Dalbavancina Baxter vials are for single use only.
Instructions for reconstitution and dilution
Aseptic technique must be used for the reconstitution and dilution of Dalbavancina Baxter.

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 alternate swirling and inverting the vial until the contents are completely dissolved. 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 clear, colourless to yellow, and free from visible particles.
5. The reconstituted concentrate must be further diluted with 5% glucose solution for infusion (50 mg/mL).
6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/mL concentrate must be transferred from the vial into an intravenous infusion bag or vial containing 5% glucose solution for infusion (50 mg/mL). For example: 25 mL of concentrate contains 500 mg of dalbavancin.
7. After dilution, the infusion solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.
8. The infusion solution must be clear, colourless to yellow, and free from visible particles.
9. If particulate matter or discolouration is observed, the solution must be discarded.

Dalbavancina Baxter 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 concentrate of Dalbavancina Baxter has been established only with 5% glucose solution for infusion (50 mg/mL).
If a common intravenous line is used to administer other medicinal products in addition to Dalbavancina Baxter, the line must be flushed before and after each Dalbavancina Baxter infusion with 5% glucose infusion solution.
Use in the paediatric population
For paediatric patients, the dose of Dalbavancina Baxter 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 into an intravenous infusion bag or vial containing 5% glucose solution for infusion (50 mg/mL). The diluted solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.
Table 1 below provides information for preparing an infusion solution with a final concentration of 2 mg/mL or 5 mg/mL (sufficient for most scenarios), to be administered via syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients aged between 3 and 12 months and weighing from 3 to 12 kg.
Alternative concentrations may be prepared, but must have a final concentration range between 1 and 5 mg/mL of dalbavancin. Refer to Table 1 to confirm calculations. The values indicated 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 Dalbavancina Baxter (final infusion concentration of 2 mg/mL or 5 mg/mL to be administered via syringe pump) in paediatric patients aged between 3 and 12 months (dose of 22.5 mg/kg)

Disposal
Dispose of any unused portion of the reconstituted solution.
Unused medicine and waste materials related to this medicine must be disposed of in accordance with
local regulations.