Dalbavancin Teva

Package leaflet: Information for the user

Dalbavancin Teva 500 mg powder for concentrate for solution for infusion

Generic medicine
Please read all of 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Dalbavancina Teva contains the active substance dalbavancin, which is an antibiotic belonging to the
glycopeptide group.
Dalbavancina Teva is used in adults and children aged 3 months and older for the treatment of
skin infections and infections of the underlying tissue layers.
Dalbavancina Teva 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 you with additional
antibiotics alongside Dalbavancina Teva.

2. What you should know before being given Dalbavancin Teva

Do not use Dalbavancin Teva 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 being given
Dalbavancin Teva:

• 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 have 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 medication for diarrhoea without first consulting your doctor.
Infusion-related reactions
Intravenous infusions of this type of antibiotic may cause redness of the upper body, hives, itching and/or skin rashes. If you experience such 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 course of 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 Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Dalbavancin Teva 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 might be pregnant, or are planning a pregnancy, consult your doctor before being 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 Teva. You must not breastfeed while receiving this medicine.
Driving and using machines
Dalbavancin Teva may cause dizziness. Be cautious when driving or operating machinery after receiving this medicine.
Dalbavancin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How Dalbavancina Teva is administered

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

• Adults: this medicine is given as a single dose of 1,500 mg or as two doses given 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 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 Teva in children with chronic kidney problems.

If you are given more Dalbavancina Teva than you should
Tell your doctor or nurse immediately if you think you have been given too much Dalbavancina Teva.

If you miss a dose of Dalbavancina Teva
Tell your doctor or nurse immediately if you are concerned about missing the second dose.

If you have any doubts 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 everyone will experience 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. 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 levels), elevated 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
• Decreased appetite
• Sleep disturbances
• 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 levels (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 experience any side effect, including those 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 the website
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 Dalbavancin Teva

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 carton and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions when stored closed in the
original container.
The chemical and physical in-use stability of Dalbavancin 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 standpoint, the medicine should be used immediately. If not used immediately, the in-use 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 reconstitution/dilution has taken place under controlled and validated aseptic conditions.
The Dalbavancin Teva solution for infusion must not be used if particulate matter is present or if the solution is cloudy.
Dalbavancin Teva is a single-use medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dalbavancina Teva contains

• The active substance 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).

Description of the appearance of Dalbavancina Teva and contents of the pack
Dalbavancina Teva powder for concentrate for solution for infusion is supplied in a single-use clear transparent glass vial of 53 mL, with a chlorobutyl rubber stopper and a red aluminium 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
TEVA B.V., Swensweg 5, 2031 GA Haarlem, 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:
Denmark Dalbavancin Teva
Austria Dalbavancin ratiopharm 500 mg Powder for a concentrate for solution for infusion
Germany Dalbavancin-ratiopharm 500 mg Powder for a concentrate for solution for infusion
Greece Dalbavancin/Teva
Spain Dalbavancina Teva 500 mg powder for concentrate for solution for perfusion EFG
Italy Dalbavancina Teva
Sweden Dalbavancin Teva

The following information is intended exclusively for physicians or healthcare professionals:
Important: Please consult the Summary of Product Characteristics (SmPC) before prescribing.
Dalbavancina Teva must be reconstituted with sterile water for injections and subsequently diluted with glucose solution for infusion 50 mg/mL (5%).
Dalbavancina Teva vials are for single use only.

Instructions for reconstitution and dilution
Aseptic technique must be used for the reconstitution and dilution of Dalbavancina Teva.

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 swirl and invert the vial alternately until the contents are completely dissolved. The 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 should be clear, colourless to yellow, and free from visible particles.
5. The reconstituted concentrate must be further diluted with glucose solution for infusion 50 mg/mL (5%).
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 glucose solution for infusion 50 mg/mL (5%). 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 is observed or a colour change occurs, the solution must be discarded.

Dalbavancina Teva 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 Dalbavancina Teva concentrate has been confirmed only with glucose solution for infusion 50 mg/mL (5%).
If a common intravenous line is used to administer other medicinal products in addition to Dalbavancina Teva, the line must be flushed before and after each Dalbavancina Teva infusion with 5% glucose infusion solution.

Use in the paediatric population
For paediatric patients, the dose of Dalbavancina Teva 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 bottle containing glucose solution for infusion 50 mg/mL (5%). The diluted solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.

The table 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. Please note that the table does NOT include all possible doses calculated for each age group, but may be used to estimate the approximate volume to verify the calculation.

Table 1: Preparation of Dalbavancina Teva (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
Discard any unused portion of the reconstituted solution.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.