Xydalba
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
14-12-2022
Valmisteyhteenveto
(SPC)
14-12-2022
Julkisesta arviointikertomuksesta
(PAR)
14-12-2022
Aktiivinen ainesosa:
dalbavancin hydrochloride
Saatavilla:
AbbVie Deutschland GmbH & Co. KG
ATC-koodi:
J01XA04
INN (Kansainvälinen yleisnimi):
dalbavancin
Terapeuttinen ryhmä:
Antibacterials for systemic use,
Terapeuttinen alue:
Soft Tissue Infections; Skin Diseases, Bacterial
Käyttöaiheet:
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-02-19
Pakkausseloste
22
B. PACKAGE LEAFLET
23
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 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.
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 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 treatm
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xydalba 500 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains dalbavancin hydrochloride equivalent to 500 mg
dalbavancin.
After reconstitution each ml contains 20 mg dalbavancin.
The diluted solution for infusion must have a final concentration of 1
to 5 mg/ml dalbavancin (see
section 6.6).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white to pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xydalba is indicated for the treatment of acute bacterial skin and
skin structure infections (ABSSSI) in
adults and paediatric patients aged 3 months and older (see sections
4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose of dalbavancin is 1,500 mg administered as either
a single infusion of
1,500 mg or as 1,000 mg followed one week later by 500 mg (see
sections 5.1 and 5.2).
_Children and adolescents aged from 6 years to less than 18 years_
The recommended dose of dalbavancin is a single dose of 18 mg/kg
(maximum 1,500 mg).
_Infants and children aged from 3 months to less than 6 years_
The recommended dose of dalbavancin is a single dose of 22.5 mg/kg
(maximum 1,500 mg).
Special populations
_Elderly_
No dose adjustment is necessary (see section 5.2).
_Renal impairment_
Dose adjustments are not required for adult and paediatric patients
with mild or moderate renal
impairment (creatinine clearance
30 to 79 ml/min). Dose adjustments are not required for adult
3
patients receiving regularly scheduled haemodialysis (3 times/week),
and dalbavancin may be
administered without regard to the timing of haemodialysis.
In adult patients with chronic renal impairment whose creatinine
clearance is < 30 ml/min and
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