Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
CILASTATIN; IMIPENEM
Hospira UK Limited
J01DH51
CILASTATIN; IMIPENEM
POWDER FOR SOLUTION FOR INFUSION
CILASTATIN 500 mg; IMIPENEM 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2010-09-02
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER IMIPENEM/CILASTATIN 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 or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET: 1. What Imipenem/Cilastatin is and what it is used for 2. What you need to know before you use Imipenem/Cilastatin 3. How to use Imipenem/Cilastatin 4. Possible side effects 5. How to store Imipenem/Cilastatin 6. Contents of the pack and other information 1. WHAT IMIPENEM/CILASTATIN IS AND WHAT IT IS USED FOR Imipenem/Cilastatin 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 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 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 may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above. Page 2 of 8 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIPENEM/CILASTATIN DO NOT USE IMIPENEM/CILASTATIN - if you are alle Belgenin tamamını okuyun
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imipenem/Cilastatin Hospira 500 mg/500 mg Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 530 mg of Imipenem monohydrate and 530 mg of Cilastatin sodium corresponding to 500 mg of Imipenem and 500 mg of Cilastatin. Excipient(s) with known effect: Each vial contains 1.6 mmol (37.5 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. Off white to yellowish white hygroscopic powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imipenem/Cilastatin Hospira 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 Hospira 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 Hospira represent the quantity of imipenem/cilastatin to be administered. Page 2 of 16 The daily dose of Imipenem/Cilastatin Hospira 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). Adults and adolescents For patients with normal renal function (creatinine clearance of ≥90ml/min), the recommended dose regimens are: 500 mg/500 mg every 6 hours OR 100 Belgenin tamamını okuyun