Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CEFEPIME HCL
DUOPHARMA (M) SDN. BHD.
CEFEPIME HCL
10vial Vials; 25vial Vials; 100vial Vials
DUOPHARMA (M) SDN. BHD.
[DUOPHARMA (M) SDN BHD] [Page 1/3] _ _ [Revision Date: 20.03.2023] CEFMEX POWDER FOR INJECTION DESCRIPTIONS: CEFMEX 500MG AND 1G POWDER FOR INJECTION: Before reconstitution: A white to pale yellow powder, After reconstitution: From colorless to amber solution COMPOSITION: Cefmex (Cefepime Hydrochloride for injection) is a cephalosporin antibiotic intended for intramuscular or intravenous administration. Each Cefmex vial contains 500mg or 1g of cefepime activity in the form of a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4.0-6.0. PHARMACODYNAMICS: Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefepime is a bactericidal agent that has a spectrum of activity against a range of Gram-positive and Gram-negative bacteria. Cefepime is highly resistant to hydrolysis by a number of beta-lactamases, has a low affinity for chromosomally encoded beta-lactamases, and exhibits rapid penetration into Gram-negative bacteria cells. Cefepime minimum bactericidal concentrations were ≤2 times the minimum inhibitory concentration for the majority of organisms tested. Cefepime has been shown to be active against most strains tested of the following organisms both in vitro and in clinical infections. GRAM-POSITIVE AEROBES:Staphylococcus aureus (including penicillinase-producing strains but excluding methicillin-resistant staphylo-cocci), Streptococcus agalactiae (Group B streptococci), Streptococcus pnemoniae (formerly Diplococcuspnemoniae), Streptococcus pyogenes (Group A streptococci), other beta-haemolytic streptococci (Group C, G, F). GRAM-NEGATIVE AEROBES: Acinetobacter calcoaceticus (subsp.anitratus,lwoffi), Enterobacter spp.(including E. aerogenes, E. agglomerans, E.cloacae, E. sakazakii), Escherichia coli, Haemophilus influenzae, (including strains of beta-lactamase producing H. influenzae), Haemophilus parainfluzae, Klebsiella spp.(i Læs hele dokumentet