DALBAVANCINA 500 mg Powder For Concentrate For Solution For Infusion

Зміст інструкції

1. Dalbavancina Baxter 500 mg powder for concentrate for solution for infusion
   1. What is Dalbavancina Baxter and what is it used for
   2. What you need to know before you are given Dalbavancina Baxter
   3. How Dalbavancina Baxter is administered
   4. Possible side effects
   5. How to store Dalbavancina Baxter
   6. Contents of the pack and other information

Dalbavancina Baxter 500 mg powder for concentrate for solution for infusion

dalbavancina

Generic medicine

Read this leaflet carefully before you are given this medicine 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

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

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

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

• If you have or have had kidney problems. Depending on your age and kidney function, your doctor may consider it appropriate to reduce the dose.
• If you suffer from diarrhoea, or if you have already suffered from diarrhoea during treatment with antibiotics.
• In case of allergyto other antibiotics such as vancomycin or teicoplanin.

Diarrhoea during or after treatment
If you develop diarrhoea duringor aftertreatment, tell your doctor immediately. Do not take
any medicine to treat diarrhoea without first consulting your doctor.

Reactions related to infusions
Intravenous infusions of these types of antibiotics can cause redness of the upper
body, hives, 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 can sometimes promote the development of a new and different infection. If this
happens, contact your doctor who will decide what to do.

Children
This medicine should not be given to children under 3 months of age. The use of
dalbavancina has not been sufficiently studied in children under 3 months of age.

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 Baxter is not recommended during pregnancy unless it is strictly necessary. This is
because the effect it may have on the foetus is not known. If you are pregnant, suspect
or are planning a pregnancy, ask your doctor for advice before you are given this
medicine. Together with your doctor, you can decide whether to be given this medicine.
It is not known whether this medicine passes into human breast milk. Ask your doctor for advice before
breastfeeding your baby. Together with your doctor, you can decide whether to be given
Dalbavancina Baxter. You should not breastfeed during the intake of this medicine.

Driving and using machines
Dalbavancina Baxter can cause dizziness. Be careful when driving and using machines
after you have been given this medicine.

Dalbavancina 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 nurse.

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

The dose for children aged 3 months and under 18 years will be calculated by the doctor based on
the child’s age and weight.
This medicine will be administered to you through an infusion directly into the bloodstream
through a vein (intravenously) for 30 minutes.

Patients with chronic kidney problems
If you have chronic kidney problems, your doctor may decide to reduce the dose. There is not enough 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 are concerned that you have been given an excessive dose
of Dalbavancina Baxter.

If you forget to take a dose of Dalbavancina Baxter
Immediately inform your doctor or nurse if you are worried about not having taken the 2nd dose.
If you have any 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
Inform your doctor immediately if you experience any of the symptoms listed below, as
they may require urgent medical attention:

• Sudden swelling of lips, face, throat or tongue; severe skin rash; itching;feeling of suffocation; decrease in blood pressure; difficulty inswallowing and/or breathing.These can all be symptoms of a hypersensitivity reaction and can 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. The symptoms may become severe or may not go away, and the stools may contain blood or mucus. These may be signs of an intestinal infection. In this situation do nottake medicines that stop or slow down bowel movements. Intestinal 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 for a similar medicine. The frequency is not known. The frequency cannot be defined based on available data.

Other side effects reported with dalbavancina 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 levels of red blood cells), elevated platelet count (thrombocytosis), increased values in blood tests of a type of white blood cells called eosinophils (eosinophilia), low levels of other types of white blood cells (leukopenia, neutropenia)
• Changes in other blood parameters
• Loss of appetite
• Sleep disorders
• Dizziness
• Change in sense of taste
• Inflammation and swelling of superficial veins, hot flushes
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• An increase in alkaline phosphatase (an enzyme present in the body)
• Itching, hives
• Genital itching (in females)
• Pain, redness or swelling at the site of the infusion
• Feeling of warmth
• Increased levels of gamma-glutamyl transferase in the blood (an enzyme produced by liver and other body tissues)
• Skin rash
• Feeling unwell (vomiting)

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

• Difficulty breathing (bronchospasm)

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

5. How to store Dalbavancina Baxter

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

Donot use this medicine after the expiry date which is stated on the package and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions if kept closed in the
original container.
The chemical and physical stability in use of Dalbavancina 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 point of view, the medicine must be used immediately. If not
used immediately, the in-use storage times and conditions prior to use are the
responsibility of the user and should normally not exceed 24 hours at a temperature
between 2 and 8 °C, unless the reconstitution/dilution has taken place under controlled and validated aseptic conditions.
The Dalbavancina Baxter solution prepared for infusion must not be used if particulate matter is present or if the solution is cloudy.
Dalbavancina Baxter is a single-use medicine.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 transparent 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, 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 with the
following denominations:
AT Dalbavancin Baxter 500 mg Pulver für ein Konzentrat zur Herstellung einer
Infusionslösung
DE Dalbavancin Baxter 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
ES Dalbavancina Baxter 500 mg polvo para concentrado para solución para perfusión EFG
FR Dalbavancine Baxter 500 mg poudre pour solution à diluer pour perfusion
FI Dalbavancin Baxter 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
IT Dalbavancina Baxter
SE Dalbavancin Baxter 500 mg pulver till koncentrat till infusionsvätska, lösning.

The following information is intended only 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 a 50 mg/mL (5%) glucose solution for infusion.
The vials of Dalbavancina Baxter are for single use only.
Instructions for reconstitution and dilution
Aseptic technique is required 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, alternate between gently swirling and inverting the vial until its contents are completely dissolved. 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 should be clear, from colourless to yellow, and free from visible particles.
• 5. The reconstituted concentrate must be further 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 into an intravenous infusion bag or bottle containing a 50 mg/mL (5%) glucose solution for infusion. 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, from colourless to yellow, and free from visible particles.
• 9. If particulate matter or a colour change is identified, the solution must be discarded.

Dalbavancina Baxter should 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. The compatibility of the reconstituted concentrate of Dalbavancina Baxter has been
verified only with a 50 mg/mL (5%) glucose solution for infusion.
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 infusion of Dalbavancina Baxter
with a 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, based on the child’s weight, from the vial into an intravenous infusion bag
or bottle containing a 50 mg/mL (5%) glucose solution for infusion. 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 a syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients
aged between 3 and 12 months and weighing between 3 and 12 kg.
Alternative concentrations may be prepared, but they must have a final concentration range
between 1 and 5 mg/mL of dalbavancin. Refer to Table 1 to confirm the
calculations. The values indicated are approximate. Note that the table is NOT comprehensive of all
possible doses calculated for each age group, but can be used to estimate the approximate volume
to verify the calculation.

Table 1: Preparation of Dalbavancina Baxter (final infusion concentration 2 mg/mL or
5 mg/mL to be administered via a syringe pump) in paediatric patients aged
between 3 and 12 months (dose of 22.5 mg/kg)

Disposal
Discard any unused portion of the reconstituted solution.
Unused medicinal product or waste material derived from such medicinal product should be disposed of in
accordance with local regulations.