Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Imipenem; Cilastatin
Hikma Farmacêutica (Portugal) S.A.
J01DH; J01DH51
Imipenem; Cilastatin
500 mg/500 milligram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Carbapenems; imipenem and enzyme inhibitor
Not marketed
2010-12-03
Compatibility and stability In keeping with good clinical and pharmaceutical practice, IMIPENEM/CILASTATIN should be administered as a freshly prepared solution with the following diluent: 0.9% Sodium Chloride Injection. INCOMPATIBILITY This medicinal product is chemically incompatible with lactate and should not be reconstituted with diluents containing lactate, however, can be administered into an IV system through which a lactate solution is being infused. This medicinal product must not be mixed with other medicinal products except those mentioned under RECONSTITUTION. AFTER RECONSTITUTION Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours. Any unused product or waste material should be disposed of in accordance with local requirements. 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 any 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 bo Izlasiet visu dokumentu
Health Products Regulatory Authority 14 February 2020 CRN0093Y3 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imipenem/Cilastatin 500mg/500mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 530 mg imipenem monohydrate equivalent to 500 mg imipenem and 530 mg cilastatin sodium salt equivalent to 500mg cilastatin. Excipient(s) with known effect: Each vial contains 20 mg of sodium bicarbonate. The total amount in the vial is 37.5 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion White to almost white or light (pale) yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imipenem/Cilastatin 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 infection - 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 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 local guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The dose recommendations for Imipenem/cilastatin represent the quantity of imipenem/cilastatin to be administered. The daily dose of Imipenem/cilastatin 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 >90 ml/min), the recommen Izlasiet visu dokumentu