国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CILASTATIN SODIUM; IMIPENEM MONOHYDRATE
FRESENIUS KABI MALAYSIA SDN. BHD
CILASTATIN SODIUM; IMIPENEM MONOHYDRATE
500mg/500mg X 10vial Vials
ACS Dobfar S.p.A.
ACSI079F01 FRONT COMPOSITION Each vial contains 500mg imipenem (as 530mg imipenem monohydrate) and 500mg cilastatin (as 530mg cilastatin sodium salt). Each vial contains sodium bicarbonate equivalent to approximately 1.6 mEq of sodium (approximately 37.6 mg) and sodium hydrogen carbonate. PHARMACEUTICAL FORM Sterile powder for solution for infusion. White to almost white or light yellow powder. Imipenem / Cilastatin Kabi is compatible with the following solution: - 0.9% Sodium Chloride Injection - 5% Dextrose Injection After dilution, the solution should be clear after agitated THERAPEUTIC INDICATIONS The activity of Imipenem/Cilastatin Kabi against an unusual broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic and mixed aerobic/anaroebic infections, as well as initial therapy prior to the identification of the causative organisms. Imipenem/Cilastatin Kabi is indicated for the treatment of the following infections due to susceptible organisms: • intra-abdominal infections • lower respiratory tract infections • gynaecological infections • septicaemia • genitourinary tract infections • bone and join infections • skin and soft tissue infections • endocarditis Imipenem/Cilastatin Kabi is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by faecal flora and fauna originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, cephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to Imipenem/Cilastatin Kabi. Imipenem/Cilastatin Kabi has demonstrated efficacy against many infections caused by aerobic and anaroebic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole 完全なドキュメントを読む