Dalbavancin accord

Package leaflet: Information for the patient

Dalbavancin Accord, 500 mg, powder for concentrate for solution for infusion
Dalbavancinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Dalbavancin Accord is and what it is 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 package and other information

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

Dalbavancin Accord contains the active substance called dalbavancin, which is an antibiotic belonging to the
glycopeptide group.
Dalbavancin Accord is used in the treatment of adults and children aged 3 months and older
with skin infections or deep skin tissue infections.
Dalbavancin Accord works by killing certain bacteria that may cause serious infections. These bacteria are killed by interfering with the formation of bacterial cell walls.
If the infection is also caused by other bacteria, your doctor may decide to use additional antibiotics alongside Dalbavancin Accord.

2. Important information before using Dalbavancin Accord

Do not use Dalbavancin Accord if you are allergic to dalbavancin or to any other
ingredient of this medicine (see section 6 for the full list).
Warnings and precautions
Before receiving Dalbavancin Accord, discuss with your doctor, pharmacist or nurse:

• if you have or have had kidney disease in the past; depending on your age and kidney function, your doctor may decide that a dose adjustment is necessary;
• 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 completing treatment, you must contact your doctor immediately.
Do not take any medicines for diarrhoea without first consulting your doctor.
Reactions at the infusion site
Intravenous infusions of this type of antibiotic may cause sudden redness of the upper body,
urticaria, itching and/or rash. If such reactions occur, your doctor may decide to discontinue treatment or slow down the infusion rate.
Other infections
Antibiotic treatment may sometimes lead to the development of a new, different infection. In such a case,
consult your doctor, who will determine further management.
Children
Dalbavancin Accord must 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 currently taking, have recently taken, or plan to take.
Pregnancy and breastfeeding
Dalbavancin Accord is not recommended during pregnancy unless clearly necessary. This is because it is unknown what effect the medicine might have on the unborn child. If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine. The decision on using Dalbavancin Accord will be made by your doctor together with you.
It is unknown whether Dalbavancin Accord passes into breast milk. Before using this medicine during breastfeeding, consult your doctor. The decision on administering Dalbavancin Accord will be made by your doctor together with you. Breastfeeding should not be undertaken during treatment with Dalbavancin Accord.
Driving and operating machinery
Dalbavancin Accord may cause dizziness. After taking this medicine, exercise caution when driving or operating machinery.
Dalbavancin Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose and is therefore considered "sodium-free".

3. How to use Dalbavancin Accord

Dalbavancin Accord will be administered by a doctor or nurse.

• Adults: Dalbavancin Accord is given as a single dose of 1500 mg or in two doses one week apart: 1000 mg on day 1 and 500 mg on day 8.
• Children and adolescents aged 6 years to less than 18 years: Dalbavancin Accord is given as a single dose of 18 mg/kg body weight (up to a maximum of 1500 mg).
• Infants and children aged 3 months to less than 6 years: Dalbavancin Accord is given as a single dose of 22.5 mg/kg body weight (up to a maximum of 1500 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 body weight.

Dalbavancin Accord will be administered as an 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 are insufficient data to recommend the use of Dalbavancin Accord in children with chronic kidney disease.
Accidental overdose of Dalbavancin Accord
If you suspect that too high a dose of Dalbavancin Accord has been administered, inform your doctor or nurse immediately.
Missed dose of Dalbavancin Accord
If you suspect that the second dose has been missed, inform your doctor or nurse immediately.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although
they do not occur in everyone.
Serious adverse reactions
If any of the following symptoms occur, contact a doctor immediately,
as immediate medical intervention may be required:

• Sudden swelling of the lips, face, throat or tongue; severe rash; itching; tightness in the throat; drop in blood pressure; difficulty swallowing and/or difficulty breathing. These may be symptoms of a life-threatening hypersensitivity reaction. Acute reactions of this type have been reported as a rare adverse reaction. It may affect 1 in 1,000 people.
• Abdominal pain (stomach ache) and/or watery diarrhoea. Symptoms may worsen or persist, and stools may contain blood or mucus. These may be symptoms of intestinal infection. In this case, do not take medications that inhibit or slow intestinal motility (peristalsis). Intestinal infection is an adverse reaction occurring not very frequently. It may affect up to 1 in 100 people.
• Changes in hearing. This adverse reaction has been reported with a similar medicine. Frequency is unknown. Frequency cannot be estimated from available data.

Other adverse reactions caused by Dalbavancin Accord are listed below.
If any of the following adverse symptoms occur, contact a doctor, pharmacist or nurse:
Common - may affect 1 in 10 people:

• Headache
• Nausea
• Diarrhoea

Uncommon - may affect 1 in 100 people:

• Vaginal infections, fungal infections, oral candidiasis
• Urinary tract infections
• Anaemia (low concentration of red blood cells), high platelet count (thrombocytosis), increased number of white blood cells called eosinophils (eosinophilia), low concentration of other types of white blood cells (leukopenia, neutropenia)
• Changes in results of other blood tests
• Decreased appetite
• Difficulty sleeping
• Dizziness
• Altered taste sensation
• Inflammation and swelling of superficial veins, sudden redness
• Cough
• Abdominal pain, abdominal discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase activity (an enzyme present in the body)
• Itching, urticaria
• Genital itching (in women)
• Pain, redness or swelling at the infusion site
• Feeling of warmth
• Increased gamma-glutamyl transferase activity (an enzyme produced by the liver and other body tissues)
• Rash
• Vomiting

Rare - may affect 1 in 1,000 people:

• Breathing difficulties (bronchospasm)

Reporting of adverse reactions
If any adverse reactions occur in adult patients or children, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 the stated month.
No special precautions for storage are required if the medicinal product is kept in its original closed packaging.
Do not use the prepared infusion solution of Dalbavancin Accord if particles are present or if the solution is cloudy.
Dalbavancin Accord is for single use only.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dalbavancin Accord contains

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

What Dalbavancin Accord looks like and contents of the pack
Dalbavancin Accord powder for solution for infusion concentrate is a white or almost white to pale yellow powder presented in a 50 mL glass vial with a green closure.
Dalbavancin Accord is available in packs containing 1 vial in a cardboard box.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: + 48 22 577 28 00
Manufacturer
Laboratorio Reig Jofre, S.A.
Gran Capitan, 10
08970 Sant Joan Despí, Barcelona
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:

Information intended exclusively for healthcare professionals:

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

1. Reconstitute the contents of each vial 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 concentrate in the vial after reconstitution 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 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 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 dalbavancin between 1 mg/mL and 5 mg/mL.
8. The infusion solution must be a clear, colourless to yellow solution, free from visible particles.
9. If particulate matter or discoloration is observed, the solution must be discarded.

Dalbavancin Accord must not be mixed with other medicinal products or intravenous infusion solutions. Sodium chloride solutions may cause precipitation and MUST NOT be used for reconstitution or dilution. 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 medicinal products in addition to Dalbavancin Accord, the line must be flushed before and after each Dalbavancin Accord infusion 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. The required dose of reconstituted dalbavancin solution should be transferred according to the above instructions, based on the child's body weight, from the vial into an infusion bag or bottle containing 50 mg/mL (5%) glucose solution for infusion.
The diluted solution must have a final concentration of dalbavancin between 1 mg/mL and 5 mg/mL.
Table 1 below provides information on the preparation of an infusion solution with a final concentration of 2 mg/mL or 5 mg/mL (sufficient for most scenarios) for administration via syringe pump, to achieve a dose of 22.5 mg/kg in children and adolescents aged 3 to 12 months weighing between 3 and 12 kg.
An alternative concentration may be prepared, but it must fall within the final concentration range of 1 mg/mL to 5 mg/mL of dalbavancin. See Table 1 to verify calculations.
The values provided are approximate. Note that the table does NOT include all possible calculated doses for each age group, but may be used to estimate approximate volume for verification of calculations.

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

Disposal
All unused portions of the reconstituted solution must be discarded.
Any unused remnants of the medicinal product or its waste must be disposed of in accordance with local regulations.