Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Imipenem; Cilastatin
Fresenius Kabi Deutschland GmbH
J01DH51
Imipenem; Cilastatin
250 mg/250 milligram(s)
Powder for solution for infusion
imipenem and enzyme inhibitor
Not marketed
2020-12-18
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER IMIPENEM/CILASTATIN 250 MG/250 MG POWDER FOR SOLUTION FOR INFUSION 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 nurse. - If you get any side effects, talk to your doctor or nurse. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIPENEM/CILASTATIN Page 2 of 8 DO NOT USE IMIPENEM/CILASTATIN if you are allergic to imipenem, cilastatin or any of the other ingredients of this medicine Soma hati kamili
Health Products Regulatory Authority 21 July 2021 CRN00C0SF Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imipenem/Cilastatin 250 mg/250 mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains imipenem monohydrate equivalent to 250 mg imipenem anhydrate and cilastatin sodium equivalent to 250 mg cilastatin. Excipient(s) with known effect: Each vial contains sodium bicarbonate equivalent to approximately 0.8 mEq of sodium (approximately 18.8 mg) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion White to almost white or light 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 section 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 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 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 recommended dose Soma hati kamili