Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta
J01DE01
CEFEPIME 1 g
SOLUTION FOR INJECTION/INFUSION
CEFEPIME 1 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2023-10-05
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFEPIME PHARMSOL 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION cefepime 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • 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 Cefepime PharmSol is and what it is used for 2. What you need to know before you are given Cefepime PharmSol 3. How Cefepime PharmSol is given 4. Possible side effects 5. How to store Cefepime PharmSol 6. Contents of the pack and other information 1. WHAT CEFEPIME PHARMSOL IS AND WHAT IT IS USED FOR Cefepime PharmSol contains the active substance cefepime, which belongs to a group of medicines called beta-lactam antibiotics. These medicines work by killing bacteria or to prevent their growth. Cefepime PharmSol can be used alone, as a drug of first choice, after obtaining the results of the test that evaluates if a bacteria is sensitive to the action of this antibiotic (sensitivity test) or, if necessary, can be used safely in combination with other antibiotics. Cefepime PharmSol is indicated: Cefepime PharmSol is indicated for the treatment of the severe infections listed below caused by cefepime susceptible pathogens _In adults and children over 12 years of age and with a body weight of ≥ 40 kg:_ • Pneumonia • Complicated urinary tract infections (including pyelonephritis) • Complicated intra-abdominal infections • Peritonitis associated with dialysis in patients on CAPD _ _ _In adults:_ • Acute biliary tract infections _In children aged 2 months up to 12 years and with a body weight of _ Olvassa el a teljes dokumentumot
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefepime PharmSol 1 g Powder for Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefepime dihydrochloride monohydrate, equivalent to 1 g of cefepime. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for Solution for Injection / Infusion White to pale yellow powder. Osmolality upon reconstitution: >700 - 1300 mOsm/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefepime PharmSol is indicated for the treatment of the severe infections listed below caused by cefepime susceptible pathogens (see sections 4.4 and 5.1). _In adults and children over 12 years of age and with a body weight of ≥ 40 kg:_ • Pneumonia • Complicated urinary tract infections (including pyelonephritis) • Complicated intra-abdominal infections • Peritonitis associated with dialysis in patients on CAPD _ _ _In adults:_ • Acute biliary tract infections _In children aged 2 months up to 12 years and with a body weight of _≤ _40 kg:_ • Pneumonia • Complicated urinary tract infections (including pyelonephritis) • Bacterial meningitis (see section 4.4) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Cefepime may be used in the empirical treatment of adults, adolescents and children aged 2 months to 12 years with febrile neutropenia that is suspected to be due to a bacterial infection. In patients at high risk of severe infections (e.g. patients with recent bone marrow transplantation, hypotension at presentation, underlying haematological malignancy, or severe or prolonged neutropenia), antimicrobial monotherapy may be inappropriate. No sufficient data exist to support the efficacy of cefepime monotherapy in such patients. A combination therapy with an aminoglycoside or glycopeptide antibiotic may be advisable, taking into consideration the patient's individual risk profile. Olvassa el a teljes dokumentumot