Xydalba - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin

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 Xydalba is and what it is used for

• 2. What you need to know before you are given Xydalba

• 3. How you will be given Xydalba

• 4. Possible side effects

• 5. How to store Xydalba

• 6. Contents of the pack and other information

1. What Xydalba is and what it is used for

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.

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

Children and adolescents

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.

Other medicines and Xydalba

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

Pregnancy and breast-feeding

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.

Driving and using machines

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

Xydalba 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 Xydalba

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.

Patients with chronic kidney problems

If you suffer from chronic kidney problems, your doctor may decide to reduce your dose.

If you are given more Xydalba than you should

Tell your doctor or nurse immediately 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 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 Xydalba 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 (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)

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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Xydalba

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.

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.

6. Contents of the pack and other information

What Xydalba 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 and/or sodium hydroxide (for pH adjustment only).

What Xydalba looks like and contents of the pack

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.

Marketing Authorisation Holder

Allergan Pharmaceuticals International Ltd.,

Clonshaugh Business & Technology Park,

Dublin 17, D17 E400, Ireland

Manufacturer

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:

België/Belgiqu­e/Belgien

Correvio

Tél/Tel: +32 (0)28 08 86 20

Et^rapuH

Ang^enuHn OapMa Etnrapua EOO^

6yn. AceH HopgaHOB 10

BG-Co^na 1592

Ten.: + 359 2 975 1395

Lorenzo Pharma OÜ Koidu str. 20–19 EE-10136 Tallinn Tel: + 372 604 1669	Correvio Tlf: +41 848 00 79 70
EXXdöa ANGELINI PHARMA HELLAS MONonpoxonH a.b.e.e. nAPArQrHS & EMnopiAs oapmakqn PooneX 4 & 17° XXp.. E.O. AOqvciv-AaLua.;, GR-14564 Nea Kq^ioia	Österreich Angelini Pharma Österreich GmbH Brigittenauer Lände 50–54 1200 Wien Tel: + 43 5 9606 0

Tnk + 30 210 626 9200

España ANGELINI PHARMA ESPAÑA, S.L. C. Osi, 7 E-08034 Barcelona Tel: + 34 93 253 45 00	Polska Angelini Pharma Polska Sp. z o.o. Aleje Jerozolimskie 181B 02–222, Warszawa Tel.: + 48 22 70 28 200
France Correvio Tél: +33 (0)1 77 68 89 17	Portugal Angelini Pharma Portugal, Unipessoal Lda Rua Joao Chagas, 53, Piso 3 P-1499–040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300
Hrvatska Angelini S.p.A Viale Amelia 70 I-00181 Roma Tel: + 39 06 78 0531	Romania Angelini Pharmaceuticals Romania SRL Str. Dr. Carol Davila, Nr. 9, Sector 5 RO-Bucuresti 050451 Tel: + 40 21 331 6767
Ireland Correvio Tel: +41 848 00 79 70	Slovenija Angelini S.p.A Viale Amelia 70 I-00181 Roma Tel: + 39 06 78 0531
Ísland Correvio Sími: +41 848 00 79 70	Slovenská republika Angelini Pharma Slovenská republika s.r.o. Júnová 33 SK-831 01 Bratislava Tel: + 421 2 59 207 320
Italia Angelini S.p.A Viale Amelia 70 I-00181 Roma	Suomi/Finland Correvio Puh/Tel: +41 848 00 79 70

Tel: + 39 06 78 0531

Kúnpog ANGELINI PHARMA HELLAS

Sverige Correvio

MONOIIPO1QIIH A.B.E.E.

nAPAroms & EMnopiAs oapmakqn

PonneX 4 & 17° XAg. E.O. AOqvciv-AaLua.;,

GR-14564 Nea Kn^ioia

TnX: + 30 210 626 9200

Latvija

SIA Livorno Pharma

Vilandes str. 17–1

LV-1010 Riga

Tel: + 371 6721 1124

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for medical or healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

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.

• 1. The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.

• 2. Do not shake. To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes.

• 3. The reconstituted concentrate in the vial contains 20 mg /ml dalbavancin.

• 4. The reconstituted concentrate must be a clear, colourless to yellow solution with no 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 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.

• 7. After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin

• 8. The solution for infusion must be clear, colourless to yellow solution with no visible particles.

• 9. If particulate matter or discoloration is identified, the solution must be discarded.