מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia
J01DE01
CEFEPIME 2 g
POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFEPIME 2 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-03-27
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFEPIME APTAPHARMA 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFEPIME APTAPHARMA 2 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WhatCefepime AptaPharma is and what it is used for 2. What you need to know before you are givenCefepime AptaPharma 3. How to useCefepime AptaPharma 4. Possible side effects 5. How to storeCefepime AptaPharma 6. Contents on the pack and other information 1. WHAT CEFEPIME APTAPHARMA IS AND WHAT IT IS USED FOR Cefepime AptaPharma is an antibiotic in the cephalosporin group of beta-lactam antibiotics. This medicine is prescribed in the treatment of certain bacterial infections caused by microbes susceptible to cefepime. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFEPIME APTAPHARMA YOU MUST NOT BE GIVEN CEFEPIME APTAPHARMA: if you are allergic to cefepime, other cephalosporins or other beta-lactam antibiotics (eg. penicillins, monobactams and carbapenems) or arginine (referred to in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Cefepime AptaPharma. Special precautions ENCEPHALOPATHY (DISEASE OF THE BRAIN) Using this medicine may result in a risk of encephalopathy (confusion, altered consciousness, seizures or abnormal movements). If any of these signs occur, inform your doctor, pharmacist or nurse immediately. This is more likely in the case of overdose or improper adjustment of the dosage in patients with kidney problems (see sections 3 and 4). ALLERGIC REACTIONS 1 Any symptoms of allergies (rash, itching, etc.) during treatment must be immediately r קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefepime AptaPharma 1 g powder for solution for injection/infusion Cefepime AptaPharma 2 g powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Cefepime AptaPharma 1 g powder for solution for injection/infusion_ Each vial contains 1.19 g cefepime dihydrochloride monohydrate corresponding to 1.0 g of cefepime. _Cefepime AptaPharma 2 g powder for solution for injection/infusion_ Each vial contains 2.38 g cefepime dihydrochloride monohydrate corresponding to 2.0 g of cefepime. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to off-white crystalline powder. After reconstitution the solution has a pH between 4.2 and 5.2 and osmolality between 383 and 389 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefepime AptaPharma is indicated for the treatment of infections listed below caused by cefepime-susceptible pathogens (see sections 4.4 and 5.1). Adults and adolescents above 12 years of age > 40 kg: Treatment of patients suffering from bacteraemia in combination or potentially in combination with one of the infections listed below: community-acquired lower respiratory tract infections and severe pneumonia, complicated and uncomplicated urinary tract infections, febrile episodes in neutropaenic patients. In the empirical treatment of patients with febrile neutropaenia: Cefepime monotherapy is indicated for the empirical treatment of patients with febrile neutropaenia. In patients with a high risk of severe infection (e.g. patients who have recently undergone a bone marrow transplantation, patients with hypotension, haematological malignancies, or severe or prolonged neutropaenia), antibiotic monotherapy may not be appropriate. There are insufficient data to support the efficacy of cefepime monotherapy in these patients. (see section 5.1.). biliary tract infections. Children aged 2 months up to 12 years ≤ 40 kg: febrile episodes during neutropaenia when the predicted duration of t קרא את המסמך השלם