Dalbavancin Accord

Package leaflet: Information for the patient

Dalbavancin Accord 500 mg powder for concentrate for infusion solution

dalbavancin
Generic medicine
Please 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, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Dalbavancina Accord contains the active substance dalbavancin, which is a glycopeptide antibiotic.
Dalbavancina Accord is used in adults and children aged 3 months and older for the treatment of skin infections or infections of the underlying tissue.
Dalbavancina Accord 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 are also present and contributing to the infection, your doctor may decide to treat the infection with additional antibiotics alongside Dalbavancina Accord.

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

Do not use Dalbavancin Accord 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 Accord:

• If you have or have had kidney problems. Depending on your age and kidney function, your doctor may need to reduce your dose.
• If you have diarrhoea, or if you have previously had diarrhoea during treatment with antibiotics.
• 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 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 lead to 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 given 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 Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Dalbavancin Accord 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 being given this medicine. You and your doctor will decide whether Dalbavancin Accord should be administered.
It is not known whether dalbavancin passes into human breast milk. Ask your doctor for advice before breastfeeding. You and your doctor will decide whether Dalbavancin Accord should be administered. You must not breastfeed while receiving Dalbavancin Accord.
Driving and using machines
Dalbavancin Accord may cause dizziness. Exercise caution when driving or using machines after being given this medicine.
Dalbavancin Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Dalbavancin Accord is administered

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

• Adults: Dalbavancin Accord is administered 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 under 18 years: Dalbavancin Accord is administered as a single dose of 18 mg/kg (maximum 1,500 mg).
• Infants and children aged 3 months to under 6 years: Dalbavancin Accord is administered as a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children aged 3 months to under 18 years will be calculated by the doctor based on the child's age and weight.
Dalbavancin Accord will be administered to you as an intravenous infusion 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 Dalbavancin Accord in children with chronic kidney problems.

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

If you miss a dose of Dalbavancin Accord
Immediately inform your doctor or nurse if you are concerned about not having received 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 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; decreased blood pressure; difficulty swallowing and/or breathing. These may all be symptoms of a hypersensitivity reaction and could 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 intestinal motility. 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 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
• Reduced appetite
• Sleep disorders
• Dizziness
• Change in taste sensation
• Inflammation and swelling of superficial veins, redness
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increase in alkaline phosphatase (an enzyme present in the body)
• Itching, urticaria
• 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 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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalbavancin Accord

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.
This medicine does not require any special storage conditions when stored closed in the
original container.
The prepared Dalbavancin Accord solution for infusion must not be used if particulate matter is present or if the solution is cloudy.
Dalbavancin Accord is for single use only.
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 Dalbavancin Accord contains

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.

After reconstitution, each mL of concentrate contains 20 mg of dalbavancin. The diluted solution for infusion must have a final concentration between 1 and 5 mg/mL of dalbavancin.

• The other components are mannitol (E421), lactose monohydrate, concentrated hydrochloric acid and/or sodium hydroxide (only for pH adjustment).

Description of the appearance of Dalbavancin Accord and contents of the pack
Dalbavancin Accord powder for concentrate for solution for infusion is contained in a 50 mL glass vial with a green flip-off cap. The vial contains a powder ranging in colour from white to off-white to light yellow.
It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
LABORATORIO REIG JOFRE, S.A.
Gran Capità 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

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

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 rotate 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 a clear, colourless to yellow solution, 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 vial 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, free from visible particles.
9. If particulate matter or discoloration is observed, the solution must be discarded.

Dalbavancina Accord 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 Accord concentrate has been established 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 Accord, the line must be flushed before and after each Dalbavancina Accord infusion with 5% glucose solution for infusion.
Use in the paediatric population
In paediatric patients, the dose of Dalbavancina Accord varies 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 and based on the child's weight, from the vial into an intravenous infusion bag or vial containing glucose solution for infusion 50 mg/mL (5%). The diluted solution must have a final dalbavancin concentration between 1 and 5 mg/mL.
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 between 3 and 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 verify calculations. The values indicated 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 Dalbavancina Accord (final infusion concentration 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
Discard any unused portion of the reconstituted solution.
Any unused medicinal product and waste materials resulting from its use should be disposed of in accordance with local regulations.