Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Ceftaroline fosamil
Pfizer Ireland Pharmaceuticals
J01DI02
ceftaroline fosamil
Antibacterials for systemic use,
Community-Acquired Infections; Skin Diseases, Infectious; Pneumonia
Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: , Complicated skin and soft tissue infections (cSSTI), Community-acquired pneumonia (CAP) , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,
Revision: 26
Authorised
2012-08-22
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER ZINFORO 600 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ceftaroline fosamil 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 Zinforo is and what it is used for 2. What you need to know before you use Zinforo 3. How to use Zinforo 4. Possible side effects 5. How to store Zinforo 6. Contents of the pack and other information 1. WHAT ZINFORO IS AND WHAT IT IS USED FOR WHAT ZINFORO IS Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil. It belongs to a group of medicines called ‘cephalosporin antibiotics.’ WHAT ZINFORO IS USED FOR Zinforo is used to treat children (from birth) and adults with: infections of the skin and the tissues below the skin an infection of the lungs called ‘pneumonia’ HOW ZINFORO WORKS Zinforo works by killing certain bacteria, which can cause serious infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZINFORO DO NOT USE ZINFORO: If you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6). If you are allergic to other cephalosporin antibiotics If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem. Do not use Zinforo if any of the above applies to you. If you are not sure, talk to your doctor or nurse before using Zinforo. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Zinforo: If you have kidney problems (your doctor may have to prescribe a lower dose) If you have ever had fits (seizures or convulsions) If you have ever had any non-severe allergic reactions to other a Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zinforo 600 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil. After reconstitution, 1 mL of the solution contains 30 mg of ceftaroline fosamil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). A pale yellowish-white to light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP. TABLE 1 DOSAGE IN ADULTS WITH NORMAL RENAL FUNCTION, CREATININE CLEARANCE (CRCL) > 50 ML/MIN INDICATIONS POSOLOGY (MG/INFUSION) INFUSION TIME (MINUTES)/FREQUENCY Standard dose a Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) 5 – 60 b /every 12 hours 3 INDICATIONS POSOLOGY (MG/INFUSION) INFUSION TIME (MINUTES)/FREQUENCY High dose b cSSTI confirmed or suspected to be caused by _S. _ _aureus_ with an MIC = 2 mg/L or 4 mg/L to ceftaroline c 600 mg 120/every 8 hours a For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable. b Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only. See sections 4.4 and 5.1. c For treatment of _S. aureus_ for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended. TABLE 2 DOSAGE IN PAEDIATRIC PAT Прочетете целия документ