Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
avibactam sodium, ceftazidime pentahydrate
Pfizer Ireland Pharmaceuticals
J01
ceftazidime, avibactam
Antibacterials for systemic use,
Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:Complicated intra-abdominal infection (cIAI)Complicated urinary tract infection (cUTI), including pyelonephritisHospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 15
Authorised
2016-06-23
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER ZAVICEFTA 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ceftazidime/avibactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zavicefta is and what it is used for 2. What you need to know before you use Zavicefta 3. How to use Zavicefta 4. Possible side effects 5. How to store Zavicefta 6. Contents of the pack and other information 1. WHAT ZAVICEFTA IS AND WHAT IT IS USED FOR WHAT ZAVICEFTA IS Zavicefta is an antibiotic medicine that contains two active substances ceftazidime and avibactam. Ceftazidime belongs to the group of antibiotics called “cephalosporins”. It can kill many types of bacteria. Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime kill some bacteria that it cannot kill on its own. WHAT ZAVICEFTA IS USED FOR Zavicefta is used in adults and paediatric patients aged 3 months and over to treat: infections of the stomach and gut (abdomen) infections of the bladder or kidneys called “urinary tract infections” an infection of the lungs called “pneumonia” infections caused by bacteria that other antibiotics may not be able to kill Zavicefta is used in adults to treat infection of the blood associated with infections of the abdomen, urinary tract, or pneumonia. HOW ZAVICEFTA WORKS Zavicefta works by killing certain types of bacteria, which can cause serious infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZAVICEFTA DO NOT USE ZAVICEFTA IF: you are allergic to ceftazidime, avibactam or any of the other ingredients of this medicine (listed in section 6) you are allergic to other cephalosporin antibiotics Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam. After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam (see section 6.6). Excipient with known effect: Zavicefta contains approximately 146 mg sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). A white to yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections (see sections 4.4 and 5.1): Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options (see sections 4.2, 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 It is recommended that Zavicefta should be used to treat infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see section 4.4). 3 Posology _Dosage in adults with creatinine clearance (CrCL) > 50 mL/min_ Table 1 shows the reco Διαβάστε το πλήρες έγγραφο