Patient Leaflet Updated 10-Dec-2024 | Baxter Healthcare Ltd
Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion
Dalbavancin Baxter 500 mg powder for concentrate for solution for infusion
dalbavancin
1. What Dalbavancin Baxter is and what it is used for
2. What you need to know before you are given Dalbavancin Baxter
3. How you will be given Dalbavancin Baxter
4. Possible side effects
5. How to store Dalbavancin Baxter
6. Contents of the pack and other information
Dalbavancin Baxter contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.
Dalbavancin Baxter 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.
This medicine 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 Baxter.
Do not use Dalbavancin Baxter if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor, pharmacist or nurse before being given Dalbavancin Baxter:
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.
Do not give this medicine to children under 3 months. The use of Dalbavancin Baxter in children under 3 months has not been studied enough.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Dalbavancin Baxter 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 this medicine.
It is not known if this medicine 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 Baxter. You should not breastfeed when given this medicine.
Dalbavancin Baxter may cause dizziness. Take care with driving and using machines after you have been given this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Dalbavancin Baxter will be given to you by a doctor or nurse.
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 this medicine through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.
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 Baxter for children with chronic kidney problems.
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Dalbavancin Baxter.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:
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:
Uncommon - may affect up to 1 in 100 people:
Rare - may affect up to 1 in 1 000 people:
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.
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 carton and vial after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions if kept unopened in the original container.
The prepared Dalbavancin Baxter solution for infusion must not be used if there are any particles or the solution is cloudy.
Dalbavancin Baxter 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.
Dalbavancin Baxter powder for concentrate for solution for infusion is provided in a single-use 53 ml clear transparent glass vial with a chlorobutyl stopper and a red aluminium flip off seal. The vial contains white to off-white to pale yellow powder.
It is available in carton packs containing 1 vial.
Detailed information on this medicine is available on the website of the UK Medicines and Healthcare Products Regulatory Agency
This leaflet was last revised in July 2024
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
+44 (0)1635 206071
+44 (0)1635 206071
+44 (0)1635 206345
http://www.baxterhealthcare.co.uk