Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
dalbavancin hydrochloride
AbbVie Deutschland GmbH & Co. KG
J01XA04
dalbavancin
Antibacterials for systemic use,
Soft Tissue Infections; Skin Diseases, Bacterial
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Revision: 15
Authorised
2015-02-19
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument