Xydalba
dalbavancin
dalbavancin
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 Xydalba is and what it is used for
What you need to know before you are given Xydalba
How you will be given Xydalba
Possible side effects
How to store Xydalba
Contents of the pack and other information
Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group. Xydalba is used to treat adults with infections of the skin or in the layers of flesh below the skin.
Xydalba 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 Xydalba.
If you have or have had kidney problems. Depending on 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.
Do not give this medicine to children under 18 years of age. The use of Xydalba in children under 18 has not yet been studied.
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
Xydalba 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 Xydalba.
It is not known if Xydalba 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 Xydalba. You should not breastfeed when given Xydalba.
Xydalba 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’.
Xydalba will be given to you by a doctor or nurse.
Xydalba 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.
You will be given Xydalba 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.
Tell your doctor or nurse immediately if you are concerned that you may have been given too much
Xydalba.
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.
life-threatening. This severe reaction has been reported as a rare side effect. It may affect
up to 1 in 1,000 people.
Headache
Feeling sick (nausea)
Diarrhoea
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 (leucopenia, 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)
Difficulty breathing (bronchospasm)
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 national reporting system listed in Appendix V 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.
This medicine does not require any special storage conditions if kept unopened in the original container.
The prepared Xydalba solution for infusion must not be used if there are any particles or the solution is cloudy.
Xydalba 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.
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 and/or sodium hydroxide (for pH adjustment only).
Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal. The vial contains white to off-white to pale yellow powder.
It is available in packs containing 1 vial.
Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate,
Dundalk,
Co. Louth, A91 P9KD, Ireland
Almac Pharma Services Ltd
Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22
60100 Ancona Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Correvio
Tél/Tel: +32 (0)28 08 86 20
UAB MRA
Totorių str. 20-9 LT-01121 Vilnius
Tel: + 370 5264 9010
Анджелини Фарма България ЕООД бул. Асен Йорданов 10
BG-София 1592
Teл.: + 359 2 975 1395
Correvio
Tél/Tel: +41 848 00 79 70
Angelini Pharma Česká republika s.r.o. Palachovo náměstí 799/5
CZ-625 00 Brno
Tel: + 420 546 123 111
Angelini Pharma Magyarország Kft Dayka Gábor u. 3., 214-215. számú iroda H-1118 Budapest
Tel: + 36 1 336 1614
Correvio
Tlf: +45 8082 6022
Correvio
Tel: +41 848 00 79 70
Correvio
Tel: +49 (0)69 33 29 62 76
Correvio
Tel: +31 (0)20 808 32 06
Lorenzo Pharma OÜ Koidu str. 20-19
EE-10136 Tallinn Tel: + 372 604 1669
Correvio
Tlf: +41 848 00 79 70
ANGELINI PHARMA HELLAS ΜΟΝΟΠΡΟΣΩΠΗ A.B.E.E.
ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ
Ρούπελ 4 & 17° Χλμ. Ε.Ο. Αθηνών-Λαμίας, GR-14564 Νέα Κηφισιά
Τηλ: + 30 210 626 9200
Angelini Pharma Österreich GmbH Brigittenauer Lände 50-54
1200 Wien
Tel: + 43 5 9606 0
ANGELINI PHARMA ESPAÑA, S.L.
C. Osi, 7
E-08034 Barcelona Tel: + 34 93 253 45 00
Angelini Pharma Polska Sp. z o.o. Aleje Jerozolimskie 181B
02-222, Warszawa
Tel.: + 48 22 70 28 200
Correvio
Tél: +33 (0)1 77 68 89 17
Angelini Pharma Portugal, Unipessoal Lda Rua João Chagas, 53, Piso 3
P-1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300
Tel: + 39 06 78 0531
Angelini Pharmaceuticals România SRL Str. Dr. Carol Davila, Nr. 9, Sector 5 RO-București 050451
Tel: + 40 21 331 6767
Correvio
Tel: +41 848 00 79 70
Tel: + 39 06 78 0531
Correvio
Sími: +41 848 00 79 70
Angelini Pharma Slovenská republika s.r.o. Júnová 33
SK-831 01 Bratislava
Tel: + 421 2 59 207 320
Angelini S.p.A Viale Amelia 70 I-00181 Roma
Tel: + 39 06 78 0531
Correvio
Puh/Tel: +41 848 00 79 70
ANGELINI PHARMA HELLAS
Correvio
ΜΟΝΟΠΡΟΣΩΠΗ A.B.E.E.
ΠΑΡΑΓΩΓΗΣ & ΕΜΠΟΡΙΑΣ ΦΑΡΜΑΚΩΝ
Ρούπελ 4 & 17° Χλμ. Ε.Ο. Αθηνών-Λαμίας, GR-14564 Νέα Κηφισιά
Τηλ: + 30 210 626 9200
Tel: +46 (0)8 408 38440
SIA Livorno Pharma Vīlandes str. 17-1 LV-1010 Riga
Tel: + 371 6721 1124
Correvio
Tel: +44 (0)203 002 8114
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Xydalba must be reconstituted with sterile water for injections and subsequently diluted with
50 mg/ml (5 %) glucose solution for infusion. Xydalba vials are for single-use only. Instructions for reconstitution and dilution
Aseptic technique must be used for reconstitution and dilution of Xydalba.
The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.
vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes.
The reconstituted concentrate in the vial contains 20 mg /ml dalbavancin.
The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5 %) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg dalbavancin.
After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
The solution for infusion must be clear, colourless to yellow solution with no visible particles.
If particulate matter or discoloration is identified, the solution must be discarded.
Xydalba must not be mixed with other medicinal products or intravenous solutions. Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution. The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
If a common intravenous line is being used to administer other medicinal products in addition to Xydalba, the line should be flushed before and after each Xydalba infusion with 5% glucose solution for infusion.
Disposal
Discard any portion of the reconstituted solution that remains unused.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.