البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
IMIPENEM ANHYDROUS CILASTATIN
MEDREG s.r.o.
IMIPENEM ANHYDROUS CILASTATIN
500/500 Milligram
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-12-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imipenem/Cilastatin MedReg 500mg/500mg Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 530.1 mg imipenem equivalent to 500mg anhydrous imipenem and 530.7mg cilastatin sodium equivalent to 500mg cilastatin. Each vial also contains 37.5mg (1.63mmol) of sodium. When reconstituted (see section 6.6) the solution contains 5mg/ml of imipenem and 5mg/ml of cilastatin. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion White to pale yellow powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imipenem/Cilastatin is indicated for the treatment of the following severe infections due to susceptible organisms (see section 4.4 and 5.1): - Nosocomial pneumonia or complicated community acquired pneumonia requiring hospitalisation. - Complicated intra-abdominal infections. - Complicated genito-urinary infections - Complicated skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The total daily dosage of Imipenem/Cilastatin should be based on the type or severity of infection, consideration of f the pathogen(s), renal function and bodyweight. Doses cited are based on a bodyweight of >70 kg. The total daily requirement should be given in equally divided doses. The dosage recommendations that follow specify the amounts of imipenem to be given. An equivalent amount of cilastatin is provided with this. One vial of Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion provides the equivalent of 500 mg anhydrous imipenem and 500 mg cilastatin. For instructions on dilution of the product see section 6.6. IRISH MEDICINE اقرأ الوثيقة كاملة