Država: Malta
Jezik: angleščina
Source: Medicines Authority
IMIPENEM, CILASTATIN
Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia
J01DH51
IMIPENEM 500 mg CILASTATIN 500 mg
POWDER FOR SOLUTION FOR INFUSION
IMIPENEM 500 mg CILASTATIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-02-16
PAGE 1 OF 8 PACKAGE LEAFLET PAGE 2 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER IMIPENEM/CILASTATIN APTAPHARMA 500 MG/500 MG POWDER FOR SOLUTION FOR INFUSION IMIPENEM/CILASTATIN 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 further questions, ask your doctor or pharmacist. - 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 of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Imipenem/Cilastatin AptaPharma is and what it is used for 2. What you need to know before you use Imipenem/Cilastatin AptaPharma 3. How to use Imipenem/Cilastatin AptaPharma 4. Possible side effects 5. How to store Imipenem/Cilastatin AptaPharma 6. Contents of the pack and other information 1. WHAT IMIPENEM/CILASTATIN APTAPHARMA IS AND WHAT IT IS USED FOR Imipenem/Cilastatin AptaPharma belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and children one year of age and above. TREATMENT Your doctor has prescribed Imipenem/Cilastatin AptaPharma because you have one (or more) of the following types of infection: • Complicated infections in the abdomen • Infection affecting the lungs (pneumonia) • Infections that you can catch during or after the delivery of your baby • Complicated urinary tract infections • Complicated skin and soft tissue infections Imipenem/Cilastatin AptaPharma may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection. Imipenem/Cilastatin AptaPharma may be used to treat bacterial infection of the blood which might be associated with a type of infection Preberite celoten dokument
PAGE 1 OF 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Imipenem/Cilastatin AptaPharma 500 mg/500 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains imipenem monohydrate equivalent to 500 mg imipenem and cilastatin sodium equivalent to 500 mg cilastatin. Excipient with known effect: Each vial contains 37,5 mg (1,6 mmol) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imipenem/Cilastatin AptaPharma is indicated for the treatment of the following infections in adults and children 1 year of age and above (see sections 4.4 and 5.1): • complicated intra-abdominal infections • severe pneumonia including hospital and ventilator-associated pneumonia • intra- and post-partum infections • complicated urinary tract infections • complicated skin and soft-tissue infections Imipenem/Cilastatin AptaPharma may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose recommendations for Imipenem/Cilastatin AptaPharma represent the quantity of imipenem/cilastatin to be administered. The daily dose of Imipenem/Cilastatin AptaPharma should be based on the type of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s) and the patient's renal function (see also section 4.4 and 5.1). PAGE 2 OF 14 Adults and adolescents For patients with normal renal function (creatinine clearance of ≥ 90 ml/min), the recommended dose regimens are: 500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 ho Preberite celoten dokument