Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xydalba

Document Subject

Generated Narrative: MedicinalProductDefinition mpf8c48790000bbf9d78cfcb64c3c5a1ee

identifier: http://ema.europa.eu/identifier/EU/1/14/986/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xydalba 500 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f8c48790000bbf9d78cfcb64c3c5a1ee

identifier: http://ema.europa.eu/identifier/EU/1/14/986/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xydalba

Attesters

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

Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group. Xydalba 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. 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.

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 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 Xydalba in children under 3 months has not been studied enough. Other medicines and Xydalba Tell your doctor or pharmacist if you are taking, 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 .

Xydalba will be given to you by a doctor or nurse. Adults: 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. Children and adolescents aged from 6 years to less than 18 years: Xydalba 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: Xydalba 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 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. There is not enough information to recommend the use of Xydalba for children with chronic kidney problems. 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.

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 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. 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.

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 AbbVie Deutschland GmbH & Co. KG Knollstra e 67061 Ludwigshafen Germany 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, 60100 Ancona Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Advanz Pharma Belgium T l/Tel: +32 (0)800 78 medicalinformation@advanzpharma.com Lietuva UAB MRA Tel: + 370 5264 9

Te .: + 359 2 975 1office@angelini.bg Luxembourg/Luxemburg Correvio T l/Tel: +44 (0)208 588 9medicalinformation@advanzpharma.com esk republika Angelini Pharma esk republika s.r.o. Tel: + 420 546 123 info@angelini.cz Magyarorsz g Angelini Pharma Magyarorsz g Kft Tel: + 36 1 336 1drugsafety@angelini.hu Danmark Correvio Tlf: +45 8082 6medicalinformation@advanzpharma.com Malta Correvio Tel: +44 (0)208 588 9medicalinformation@advanzpharma.com Deutschland Advanz Pharma Germany GmbH Tel: +49 (0)800 1802 Nederland Correvio Tel: +31 (0)20 808 32 medicalinformation@advanzpharma.com medicalinformation@advanzpharma.com Eesti Lorenzo Pharma O
Tel: + 372 6041Norge Correvio Tlf: +44 (0)208 588 9medicalinformation@advanzpharma.com

ANGELINI PHARMA HELLAS A.B.E.E. : + 30 210 626 9info@angelinipharma.gr sterreich Angelini Pharma sterreich GmbH Tel: + 43 5 9606 0 office@angelini.at Espa a ANGELINI PHARMA ESPA A, S.L. Tel: + 34 93 253 45 Polska Angelini Pharma Polska Sp. z o.o. Tel.: + 48 22 70 28 angelini@angelini.pl France Correvio SAS T l: +33 (0)1 77 68 89 medicalinformation@advanzpharma.com Portugal AbbVie, Lda. Tel: + 351 (0)21 1908Hrvatska Angelini Pharma S.p.A Tel: + 39 06 78 0Rom nia Angelini Pharmaceuticals Rom nia SRL Tel: + 40 21 331 6office@angelini.ro Ireland Correvio Tel: +352 1800 851 medicalinformation@advanzpharma.com Slovenija Angelini Pharma S.p.A Tel: + 39 06 78 0 sland Correvio S mi: +44 (0)208 588 9medicalinformation@advanzpharma.com Slovensk republika Angelini Pharma Slovensk republika s.r.o. Tel: + 421 2 59 207 office@angelini.sk Italia Angelini Pharma S.p.A Tel: + 39 06 78 0Suomi/Finland Correvio Puh/Tel: +44 (0)208 588 9medicalinformation@advanzpharma.com

ANGELINI PHARMA HELLAS A.B.E.E. : + 30 210 626 9info@angelinipharma.gr Sverige Correvio Tel: +46 (0)20 088 02 medicalinformation@advanzpharma.com Latvija SIA Livorno Pharma Tel: + 371 6721 1United Kingdom (Northern Ireland) Mercury Pharmaceuticals Limited Tel: +44 (0)208 588 9medicalinformation@advanzpharma.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: