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Dalbavancin 500 mg powder for concentrate for solution for infusion

Active Ingredient:
dalbavancin hydrochloride
Company:  
Zentiva See contact details
ATC code: 
J01XA04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 13 Feb 2026
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Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 17780/1349.

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Dalbavancin 500mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

Dalbavancin 500 mg powder for concentrate for solution for infusion

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 further 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.

What is in this leaflet:

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

1. What Dalbavancin is and what it is used for

The name of your medicine is Dalbavancin 500 mg powder for concentrate for solution for infusion (called Dalbavancin throughout this leaflet) it contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.

Dalbavancin is used to treat adults and children aged 3 months and over with infections of the skin or in the layers of flesh below the skin.

Dalbavancin works by killing certain bacteria, which can cause serious infections. It kills these bacteria by interfering with the formation of bacterial cell walls.

If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Dalbavancin.

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

Do not use Dalbavancin if you are allergic to dalbavancin or 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:

  • If you have or have had kidney problems. Depending on your age and the condition of your kidney, your doctor may have to reduce your dose.
  • If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated 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 your treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Infusion-related reactions

Intravenous infusions with these types of antibiotics can cause flushing of the upper body, hives, itching and/or rashes. If you experience these types of reactions your doctor may decide to stop or slow the infusion.

Other infections

Using antibiotics may sometimes allow a new and different infection to develop. If this happens tell your doctor and they will decide what to do.

Children

Do not give this medicine to children under 3 months. The use of Dalbavancin in children under 3 months has not been studied enough.

Other medicines and Dalbavancin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

Pregnancy and breast-feeding

Dalbavancin is not recommended during pregnancy unless clearly necessary. This is because it is not known what effect it might have on an unborn baby. Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. You and your doctor will decide if you will be given Dalbavancin.

It is not known if Dalbavancin passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby. You and your doctor will decide if you will be given Dalbavancin. You should not breastfeed when given Dalbavancin.

Driving and using machines

Dalbavancin may cause dizziness. Take care with driving and using machines after you have been given this medicine.

Dalbavancin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How you will be given Dalbavancin

Dalbavancin will be given to you by a doctor or nurse.

  • Adults: Dalbavancin is given in a single dose of 1,500 mg or in two doses a week apart: 1,000 mg on Day 1 and 500 mg on Day 8.
  • Children and adolescents aged from 6 years to less than 18 years: Dalbavancin is given in a single dose of 18 mg/kg (maximum 1,500 mg).
  • Infants and children aged from 3 months to less than 6 years: Dalbavancin is given in 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 age and weight of the child.

You will be given Dalbavancin through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.

Patients with chronic kidney problems

If you suffer from chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of Dalbavancin for children with chronic kidney problems.

If you are given more Dalbavancin than you should

Tell your doctor or nurse immediately if you are concerned that you may have been given too much Dalbavancin.

If you miss a dose of Dalbavancin

Tell your doctor or nurse immediately if you are concerned that you are missing the 2nd dose.

If you have any further questions on the use of this medicine, ask 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 straight away if you get any of these symptoms - you may need urgent medical attention:

  • Sudden swelling of your lips, face, throat, or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing. These may all be signs of a hypersensitivity reaction and may be life-threatening. This severe 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. The symptoms may become severe or may not go away and the stools may contain blood or mucus. These may be signs of an infection of the bowel. In this situation, you should not take medicines that stop or slow bowel movement. Infection of the bowel has been reported as an uncommon side effect. It 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 not known. The frequency cannot be estimated from the available data.

Other side effects reported with Dalbavancin are listed below.

Talk to your doctor, pharmacist, or nurse if you get any of the following side effects:

Common (may affect up to 1 in 10 people)

  • Headache
  • Feeling sick (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 blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leukopenia, neutropenia)
  • Changes in other blood tests
  • Decreased appetite
  • Difficulty sleeping
  • Dizziness
  • Change in sense of taste
  • Inflammation and swelling of surface veins, flushing
  • Cough
  • Abdominal pain and discomfort, indigestion, constipation
  • Abnormal liver function test
  • An increase in alkaline phosphatase (an enzyme found in the body)
  • Itching, hives
  • Genital itching (females)
  • Pain, redness or swelling at the place where the infusion was given
  • Feeling hot
  • Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
  • Rash
  • Being sick (vomiting)

Rare (may affect up to 1 in 1 000 people)

  • Difficulty breathing (bronchospasm)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalbavancin

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 vial after EXP. The expiry date refers to the last day of that month.

Chemical and physical in-use stability of Dalbavancin has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25 °C. The total in-use stability from reconstitution to administration should not exceed 48 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions. Do not freeze.

This medicine does not require any special storage conditions if kept unopened in the original container.

The prepared Dalbavancin solution for infusion must not be used if there are any particles or the solution is cloudy.

Dalbavancin is for single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Dalbavancin contains
  • The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
  • The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid 0.1M and/or sodium hydroxide 0.1M (for pH adjustment only).

What Dalbavancin looks like and contents of the pack

Dalbavancin powder for concentrate for solution for infusion is provided in a 50 ml glass vial closed with a grey bromobutyl stopper and sealed with aluminium seal and a green flip off seal. The vial contains white to off-white to pale yellow powder or cake.

It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom

Manufacturer

GALENICUM HEALTH, S.L.U.
Calle Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

or

SAG MANUFACTURING, S.L.U.
Ctra. N-I, Km 36
28750
San Agustín de Guadalix
Madrid
Spain

This leaflet was last revised in September 2025

1065046390

Zentiva
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Address
First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
Medical Information Direct Line
+44 (0)800 090 2408
Customer Care direct line
+44 (0)844 8793 188
E-mail
[email protected]
WWW
https://www.zentiva.co.uk/contact/mi-form
Medical Information e-mail
[email protected]