Dalbavancin Zentiva

Patient Information Leaflet

Dalbavancin Zentiva 500 mg powder for concentrate for solution for infusion

Generic medicine
Please read this leaflet carefully before this medicine is administered 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Dalbavancina Zentiva contains the active substance dalbavancin, which is an antibiotic belonging to the
glycopeptide group.
Dalbavancina Zentiva is used in adults and children aged 3 months and older with skin or soft tissue
infections.
Dalbavancina Zentiva 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 Zentiva.

2. What you must know before being given Dalbavancin Zentiva

Do not use Dalbavancin Zentiva if you are allergic to dalbavancin 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 are given Dalbavancin Zentiva:

• 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 diarrhea, or if you have previously experienced diarrhea during antibiotic treatment.
• If you are allergic to other antibiotics such as vancomycin or teicoplanin.

Diarrhea during or after treatment
If you develop diarrhea during or after treatment, inform your doctor immediately. Do not take
any medication for diarrhea without first consulting your doctor.
Infusion-related reactions
Intravenous infusions of this type of antibiotic may cause flushing 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 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
Do not administer this medicine to children under 3 months of age. The use of Dalbavancin Zentiva in children under 3 months has not been sufficiently studied.
Other medicines and Dalbavancin Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Dalbavancin Zentiva is not recommended during pregnancy unless strictly necessary. This is because the effect on the fetus is unknown. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before receiving this medicine. Together with your doctor, you can decide whether to receive Dalbavancin Zentiva.
It is not known whether Dalbavancin Zentiva passes into human breast milk. Consult your doctor before breastfeeding. Together with your doctor, you can decide whether to receive Dalbavancin Zentiva. You must not breastfeed while receiving Dalbavancin Zentiva.
Driving and using machines
Dalbavancin Zentiva may cause dizziness. Exercise caution when driving or operating machinery after receiving this medicine.
Dalbavancin Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How Dalbavancin Zentiva is administered

Dalbavancin Zentiva will be administered to you by a doctor or nurse.

• Adults: Dalbavancin Zentiva 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: Dalbavancin Zentiva is given as a single dose of 18 mg/kg (maximum 1,500 mg).
• Infants and children from 3 months to less than 6 years of age: Dalbavancin Zentiva is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).
  The dose for children from 3 months to less than 18 years of age will be calculated by the doctor based on the child's age and weight.
  Dalbavancin Zentiva will be administered to you via an intravenous infusion directly into the bloodstream through a vein (intravenously). The infusion will last 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 Dalbavancin Zentiva in children with chronic kidney problems.
  If you are given more Dalbavancin Zentiva than you should
  Tell your doctor or nurse immediately if you are concerned that you have been given too much Dalbavancin Zentiva.
  If you miss a dose of Dalbavancin Zentiva
  Tell your doctor or nurse immediately 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 everyone 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; sensation of suffocation; drop in blood pressure; difficulty swallowing and/or breathing. These may all be symptoms of a hypersensitivity reaction and can be life-threatening. This serious reaction has been reported as a rare adverse 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 an intestinal infection. In this case, do not take medicines that stop or slow down intestinal motility. Intestinal infections have been reported as an uncommon adverse effect. They may affect up to 1 in 100 people.
• Changes in hearing. This has been reported as an adverse effect with a similar medicine. The frequency is unknown. The frequency cannot be estimated from the available data.

Other side effects reported with Dalbavancin Zentiva 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), high platelet count in the blood (thrombocytosis), increased levels of a type of white blood cells called eosinophils in the blood (eosinophilia), low levels of other types of white blood cells (leucopenia, neutropenia)
• Changes in other blood tests
• Reduced 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
• Increased 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 levels of gamma-glutamyl transferase in the blood (an enzyme produced by liver tissues 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 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 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 Dalbavancin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after "Exp". The expiry date refers to the
last day of that month.
The chemical and physical in-use stability of Dalbavancin Zentiva has been demonstrated for both the
reconstituted concentrate and the diluted solution for 48 hours at a temperature equal to or below 25°C.
The total in-use stability from reconstitution to administration must not exceed 48 hours.
From a microbiological standpoint, the product 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 reconstitution/dilution has been carried out under
controlled and validated aseptic conditions. Do not freeze.
This medicine does not require any special storage conditions when stored in its original closed container.
The prepared Dalbavancin Zentiva solution for infusion must not be used if particulate matter is present or
if the solution is cloudy.
Dalbavancin Zentiva is a single-use medicine.
Do not dispose of any medicine 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 Zentiva 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 0.1 M and/or sodium hydroxide 0.1 M (only to adjust pH).

Description of the appearance of Dalbavancina Zentiva and contents of the pack
Dalbavancina Zentiva powder for concentrate for solution for infusion is supplied in a 50 mL glass vial closed with a grey bromobutyl stopper and sealed with an aluminium seal and a green tear-off cap. The vial contains a white to off-white or pale yellow powder or porous mass.
It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan
Italy

Manufacturer
SAG Manufacturing, S.L.U. Ctra. N-I, Km 36
San Agustín de Guadalix,
28750 Madrid – Spain
or
Galenicum Health, S.L.U. Sant Gabriel, 50
08950 Esplugues de Llobregat
Barcelona – Spain

The following information is intended exclusively for healthcare professionals:

Important: Before prescribing, consult the Summary of Product Characteristics (SmPC).
Dalbavancin Zentiva must be reconstituted with sterile water for injections and subsequently diluted with a 50 mg/mL (5%) glucose infusion solution.
Dalbavancin Zentiva vials are for single use only.
Instructions for reconstitution and dilution
Aseptic technique must be used for the reconstitution and dilution of Dalbavancin Zentiva.

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. Reconstitution 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 a 50 mg/mL (5%) glucose infusion solution.
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 a 50 mg/mL (5%) glucose infusion solution. 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. Dalbavancin Zentiva 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 dalbavancin concentrate has been established only with a 50 mg/mL (5%) glucose infusion solution. If a common intravenous line is used to administer other drugs in addition to Dalbavancin Zentiva, the line must be flushed before and after each dalbavancin infusion with a 5% glucose infusion solution.

Use in the paediatric population
For paediatric patients, the dose of Dalbavancin Zentiva 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, as per the instructions above, based on the child's weight, from the vial into an intravenous infusion bag or vial containing a 50 mg/mL (5%) glucose infusion solution. The diluted solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.
Table 1 below provides guidance 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 3 to 12 months and weighing 3 to 12 kg. Alternative concentrations may be prepared, but must fall within a final concentration range of 1 to 5 mg/mL of dalbavancin. Refer to Table 1 to verify calculations. The values provided are approximate. 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 Dalbavancin Zentiva (final infusion concentration of 2 mg/mL or 5 mg/mL to be administered via syringe pump) in paediatric patients aged 3 to 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.