500 mg powder for concentrate for infusion solution, solution.
dalbavancin
What Xydalba is and what it is used for
Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide type.
Xydalba is used to treat adults with infections in the skin or the layers under the skin.
Xydalba works by killing certain bacteria that can cause serious infections. It kills these bacteria by disrupting the formation of the bacterial cell wall.
If other bacteria are also causing your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.
What you need to know before you use Xydalba
Do not use Xydalba
Do not use Xydalba 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 using Xydalba:
- if you have or have had kidney problems. Depending on the condition of your kidneys, your doctor may need to reduce your dose.
- if you suffer from diarrhea or if you have previously suffered from diarrhea during treatment with antibiotics.
- if you are allergic to other antibiotics such as vancomycin or teicoplanin.
Diarrhea during or after treatment
If you suffer from diarrhea during or after treatment, you should contact a doctor immediately. Do not use any medication to treat your diarrhea without first consulting a doctor.
Infusion-related reactions
Intravenous infusions of this type of antibiotic may cause redness on the upper body, hives, itching, and/or rash. If you experience any of these reactions, your doctor may decide to stop treatment or reduce the infusion rate.
Other infections _
Treatment with antibiotics can sometimes cause new and other infections to develop. If this occurs, you should talk to a doctor who will decide what measures should be taken.
Children and young people
This medicine should not be given to children under 18 years of age. The use of Xydalba has not been studied in children under 18 years of age.
Other medicines and Xydalba
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. This is because it is not known what effect it can have on the unborn child. You and your doctor will decide whether you should be given Xydalba.
It is not known whether Xydalba is excreted in human milk. Ask your doctor for advice before you breastfeed your baby. You and your doctor will decide whether you should be given Xydalba. You should not breastfeed when you are given Xydalba.
Driving ability and use of machinery
Xydalba may cause dizziness. Take care when driving and using machines after receiving this medicine.
Xydalba contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost sodium-free.
How to use Xydalba
Xydalba is given to you by a doctor or nurse.
Xydalba is given as a single dose of 1,500 mg or as two doses one week apart: 1,000 mg on day 1 and 500 mg on day 8.
You will receive Xydalba by drip directly into the blood 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 the dose.
If you have been given too much Xydalba
Tell your doctor or nurse straight away if you are concerned that you may have been given too much Xydalba.
If you miss a dose of Xydalba
Tell your doctor or nurse immediately if you are concerned that you may have missed the second dose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell your doctor immediately if you get any of these symptoms – you may need emergency medical attention :
- Sudden swelling of the lips, face, throat, or tongue, severe rash, itching, tight throat, drop in blood pressure, difficulty swallowing, and/or difficulty breathing. All of these can be signs of a hypersensitivity reaction and can be life-threatening. This serious reaction has been reported as a rare side effect. It may occur in up to 1 in 1,000 users.
- Abdominal pain (stomach ache) and/or watery diarrhea. Symptoms may be severe or prolonged and the stool may contain blood or mucus. This could be a sign of an infection in the gut. In this situation, you should not take medicines that stop bowel movements or make bowel movements slow. Infection of the intestine has been reported as a less common side effect. It may affect up to 1 in 100 users.
- Hearing changes. This has been reported as a side effect of a similar drug. Side effect one has been reported and occurs in an unknown number of users.
Additional side effects reported with Xydalba are listed below.
Talk to your doctor, pharmacist, or nurse if you experience any of the following side effects:
Common – may affect up to 1 in 10 users:
- Headache
- Nausea
- Diarrhea
Uncommon – may affect up to 1 in 100 users:
- Vaginal infections, fungal infections, thrush in the mouth
- Urinary tract infections
- Anemia (low levels of red blood cells ), high levels of platelets ( thrombocytosis ), increased levels of a type of white blood cell called eosinophils ( eosinophilia ), low levels of other types of white blood cells ( leukopenia, neutropenia )
- Changes in other blood values
- Decreased appetite
- Difficulty sleeping
- Dizziness
- Taste changes
- Inflammation and swelling of superficial veins, redness
- Cough
- Abdominal pain and discomfort, indigestion, constipation
- Abnormal liver function values
- An increase in alkaline phosphatase (an enzyme found in the body)
- Itching, hives
- Genital itching (women)
- Pain, redness, or swelling at the site where the infusion was given
- Feeling of warmth
- Increase in blood levels of gamma-glutamyltransferase (an enzyme produced in the liver and other body tissues) in the blood.
- Rash
- Nausea (vomiting)
Rare – may affect up to 1 in 1,000 users:
- Difficulty breathing ( bronchospasm )
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Swedish Medicines Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase information about drug safety.Postal address
How to store Xydalba
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the vial after EXP. The expiration date is the last day of the specified month.
This medicine does not require special storage instructions if it is stored unopened in the original packaging.
The reconstituted Xydalba solution for infusion must not be used if it contains particles or if the solution is cloudy.
Xydalba is for single use only.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dalbavancin. One vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
- Other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid, and/or sodium hydroxide (for pH adjustment only).
What Xydalba looks like and what pack sizes
Xydalba powder for concentrate for solution for infusion is supplied in a 48 ml glass vial with a green flip cap. The vial contains white to off-white to pale yellow powder.
Available in packs of 1 vial.
AbbVie Deutschland GmbH & Co. KG
Knollstraße
67061 Ludwigshafen
Germany
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate, Dundalk,
Co. Louth, A91 P9KD, Ireland
Almac Pharma Service Ltd
Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Aziende Chimiche Riunite Angelini Francesco ACRAFSpA Via Vecchia del Pinocchio, 22
60100 Ancona
Italy
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
Correvio
Phone: +46 (0)20 088 02 36
medicalinformation@advanzpharma.com