Dalbavancin Accord

Leaflet attached to the packaging: Patient information

Dalbavancin Accord, 500 mg, powder for concentrate for solution for infusion

Dalbavancin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further 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.

Table of contents of the leaflet

• 1. What is Dalbavancin Accord and what is it used for
• 2. Important information before using Dalbavancin Accord
• 3. How to use Dalbavancin Accord
• 4. Possible side effects
• 5. How to store Dalbavancin Accord
• 6. Contents of the pack and other information

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

Dalbavancin Accord contains the active substance dalbavancin, which is an antibioticfrom the group of
glycopeptides.
Dalbavancin Accord is used to treat adults and children from 3 months of age and older
with skin or soft tissue infections.
The action of Dalbavancin Accord is to kill certain bacteria that can cause severe
infections. These bacteria are killed as a result of interfering with the formation of bacterial cell walls.
If the infection is also caused by other bacteria, the doctor may decide to use
additional antibiotics, in addition to Dalbavancin Accord.

2. Important information before using Dalbavancin Accord

Dalbavancin Accord should not be usedin case of allergyto dalbavancin or any other
component of this medicine (see list in section 6).
Warnings and precautions

Before taking Dalbavancin Accord, you should discuss it with your doctor, pharmacist, or nurse:

• in case of kidney diseasecurrently or in the past; depending on age and kidney function, the doctor may decide to reduce the dose;
• in case of diarrheaor if diarrhea occurred during previous antibiotic treatment;
• in case of allergyto other antibiotics, such as vancomycin or teicoplanin.

Diarrhea during or after treatment
In case of diarrhea duringor aftertreatment, you should immediatelyinform your doctor.
Do not take any medicines for diarrhea without consulting your doctor first.
Reactions related to the infusion site of the medicine
Intravenous infusions of this type of antibiotic can cause sudden redness of the upper body,
hives, itching, and (or) rash. If such a reaction occurs, the doctor may decide
to discontinue treatment or slow down the infusion.
Other infections
The use of antibiotics can sometimes lead to the development of a new, different infection. In such a situation,
you should consult your doctor, who will decide on further action.

Children

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

Other medicines and Dalbavancin Accord

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

Dalbavancin Accord should not be used during pregnancy unless it is absolutely necessary.
This is because it is not known what effect the medicine could have on the unborn child. If
you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child,
you should consult your doctor or pharmacist before taking this medicine. The decision to use
Dalbavancin Accord will be made by your doctor together with you.
It is not known whether Dalbavancin Accord passes into breast milk. Before taking the medicine during
breastfeeding, you should consult your doctor. The decision to administer Dalbavancin Accord
will be made by your doctor together with you. You should not breastfeed while taking Dalbavancin Accord.

Driving and using machines

Dalbavancin Accord may cause dizziness. After taking this medicine, you should be careful
when driving vehicles and operating machines.

Dalbavancin Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is considered 'sodium-free'.

3. How to use Dalbavancin Accord

Dalbavancin Accord will be administered by your doctor or nurse.

• Adults:Dalbavancin Accord is administered in a single dose of 1500 mg or in two doses at an interval of one week: 1000 mg on day 1 and 500 mg on day 8.
• Children and adolescents from 6 years to less than 18 years:Dalbavancin Accord is administered in a single dose of 18 mg/kg body weight (maximum 1500 mg).
• Infants and children from 3 months to less than 6 years:Dalbavancin Accord is administered in a single dose of 22.5 mg/kg body weight (maximum 1500 mg). The dose for children from 3 months to less than 18 years will be calculated by the doctor based on the child's age and body weight.

Dalbavancin Accord will be administered by intravenous infusion directly into the bloodstream over 30 minutes.

Patients with chronic kidney disease

In case of chronic kidney disease, the doctor may decide to reduce the dose. There is
insufficient data to recommend the use of Dalbavancin Accord in children with chronic kidney disease.

Taking a higher dose of Dalbavancin Accord than recommended

In case of suspected overdose of Dalbavancin Accord, you should immediately
inform your doctor or nurse.

Missing a dose of Dalbavancin Accord

In case of suspected missing of the second dose, you should immediately
inform your doctor or nurse.
In case of further questions about the use of this medicine, you should consult your doctor,
pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dalbavancin Accord can cause side effects, although not everybody gets them.

Severe side effects

If you experience any of the following symptoms, you should immediately contact your doctor, as you may need urgent medical attention:

Sudden swelling of the lips, face, throat, or tongue; severe rash; itching; constriction of the throat; low blood pressure; difficulty swallowing and (or) difficulty breathing. These may be symptoms of a life-threatening allergic reaction. Acute reactions of this type have been reported as rare side effects. They may affect up to 1 in 1000 people.

• Abdominal pain (stomach pain)and (or) watery diarrhea. Symptoms may worsen or may not improve, and stools may contain blood or mucus. These may be symptoms of intestinal infection. In this case, you should not take medicines that stop or slow down bowel movements (peristalsis). Intestinal infection is an uncommon side effect. It may affect up to 1 in 100 people.
• Changes in hearing. The side effect has been reported in a similar medicine. The frequency is not known. The frequency cannot be estimated from the available data.

Other side effects caused by Dalbavancin Accord are listed below.

If you experience any of the following side effects, you should contact your doctor, pharmacist, or nurse:

Common -may affect up to 1 in 10 people:

• Headache
• Nausea
• Diarrhea

Uncommon -may affect up to 1 in 100 people:

• Vaginal infections, fungal infections, oral thrush
• Urinary tract infections
• Anemia (low red blood cell count), high platelet count (thrombocytosis), increased white blood cell count called eosinophils (eosinophilia), low count of other types of white blood cells (leukopenia, neutropenia)

changes in blood test results

• Decreased appetite
• Difficulty sleeping
• Dizziness
• Change in taste
• Inflammation and swelling of veins under the skin, sudden redness
• Cough
• Abdominal pain, discomfort in the abdominal area, indigestion, constipation
• Abnormal liver test results
• Increased activity of alkaline phosphatase (an enzyme found in the body)
• Itching, hives
• Genital itching (in women)
• Pain, redness, or swelling at the infusion site
• Feeling of heat
• Increased activity of gamma-glutamyltransferase (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare -may affect up to 1 in 1000 people:

• Breathing difficulties (bronchospasm)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalbavancin Accord

Store the medicine out of 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 the month.
There are no special precautions for storage of the medicinal product if stored in the original package.
Do not use the prepared solution of Dalbavancin Accord for infusion if it contains particles or is cloudy.
Dalbavancin Accord is intended for single use.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dalbavancin Accord contains

• The active substance of the medicine is dalbavancin. Each vial of powder contains 500 mg of dalbavancin in the form of dalbavancin hydrochloride. After reconstitution, each mL of concentrate contains 20 mg of dalbavancin. The diluted infusion solution must have a final concentration of 1 mg/mL to 5 mg/mL of dalbavancin.
• Other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid, and (or) sodium hydroxide (only for pH adjustment).

What Dalbavancin Accord looks like and contents of the pack

Dalbavancin Accord powder for concentrate for solution for infusion is available in a 50 mL glass vial with a green closure. The vial contains a white or almost white to light yellow powder.
The medicine is available in packs containing 1 vial, in a cardboard box.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: + 48 22 577 28 00

Manufacturer

Laboratorio Reig Jofre, S.A.
Gran Capitan, 10
08970 Sant Joan Despí, Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Important:before prescribing the medicine, you should read the Summary of Product Characteristics (SmPC).
Dalbavancin Accord must be reconstituted with sterile water for injections, and then diluted with 50 mg/mL (5%) glucose solution for infusion.
The vials of Dalbavancin Accord are for single use.
Instructions for reconstitution and dilution
To reconstitute and dilute Dalbavancin Accord, you should use aseptic technique.

• 1. The contents of the individual vials should be reconstituted by slowly adding 25 mL of water for injections.
• 2. Do not shake.To avoid foaming, you should slowly and gently rotate and turn the vial until the contents are completely dissolved. Reconstitution may take up to 5 minutes.
• 3. The concentrate in the vial after reconstitution contains 20 mg/mL of dalbavancin.
• 4. The reconstituted concentrate must be a clear, colorless to yellow solution without visible particles.
• 5. The reconstituted concentrate must be further diluted with 50 mg/mL (5%) glucose solution for infusion.
• 6. To dilute the reconstituted concentrate, the appropriate volume of 20 mg/mL concentrate must be transferred from the vial to an infusion bag or bottle containing 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 of 1 mg/mL to 5 mg/mL of dalbavancin.
• 8. The infusion solution must be a clear, colorless to yellow solution without visible particles.
• 9. If particles or discoloration are observed, the solution must be discarded.

Dalbavancin Accord should not be mixed with other medicinal products or infusion solutions. Sodium chloride solutions may cause precipitation and MUST NOT be used for reconstitution or dilution. The compatibility of the reconstituted Dalbavancin Accord concentrate has been established only with 50 mg/mL (5%) glucose solution for infusion.
If a common intravenous line is used to administer other medicines in addition to Dalbavancin Accord, the line should be flushed before and after each infusion of Dalbavancin Accord with 5% glucose solution for infusion.
Use in children and adolescents
In children and adolescents, the dose of Dalbavancin Accord will vary depending on the child's age and body weight, up to a maximum of 1500 mg. You should transfer the required dose of the reconstituted dalbavancin solution from the vial to an infusion bag or bottle containing 50 mg/mL (5%) glucose solution for infusion, based on the child's body weight. The diluted solution must have a final concentration of 1 mg/mL to 5 mg/mL of dalbavancin.
Table 1 below provides information on the preparation of the infusion solution with a final concentration of 2 mg/mL or 5 mg/mL (sufficient for most scenarios) for administration via a syringe pump to achieve a dose of 22.5 mg/kg in children and adolescents from 3 to 12 months weighing from 3 to 12 kg.
You can prepare an alternative concentration, but it must have a final concentration range of 1 mg/mL to 5 mg/mL of dalbavancin. See Table 1 to confirm the calculations.
The values are approximate. Note that the table DOES NOT include all possible calculated doses for each age group, but it can be used to estimate the approximate volume for verification of calculations.

Table 1. Preparation of Dalbavancin Accord (final infusion solution concentration 2 mg/mL or 5 mg/mL for administration via a syringe pump) in children and adolescents from 3 to 12 months (dose 22.5 mg/kg body weight).

Disposal
All unused portions of the reconstituted solution should be disposed of.
Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.