País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMIPENEM; CILASTATIN SODIUM
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
IMIPENEM; CILASTATIN SODIUM
1Units Units; 0 20 ml 0 mL; 20 ml mL
Merck Sharp & Dohme LLC
Not Applicable Llegiu el document complet
TIENAM LPC- MK0787B -IV-032022a (imipenem and cilastatin sodium, MSD) LOCAL PRODUCT CIRCULAR I.V. Infusion TIENAM ® (imipenem and cilastatin sodium, MSD) TIENAM® (imipenem and cilastatin sodium, MSD) is a broad-spectrum beta-lactam antibiotic supplied as intravenous infusion only. TIENAM consists of two components: (1) imipenem, the first of a new class of beta-lactam antibiotics, the thienamycins; and (2) cilastatin sodium, a specific enzyme inhibitor that blocks the metabolism of imipenem in the kidney, and substantially increases the concentration of intact imipenem in the urinary tract. Imipenem and cilastatin sodium are present in TIENAM in a 1:1 ratio by weight. The thienamycin class of antibiotics, to which imipenem belongs, is characterized by a spectrum of potent bactericidal activity broader than that provided by any other antibiotic studied. MICROBIOLOGY TIENAM is a potent inhibitor of bacterial cell wall synthesis and is bactericidal against a broad spectrum of pathogens — gram- positive and gram - negative, aerobic and anaerobic. TIENAM shares with the newer cephalosporins and penicillins a broad spectrum of activity against gram-negative species, but is unique in retaining the high potency against gram- positive species, previously associated only with earlier narrow-spectrum beta-lactam antibiotics. The spectrum of activity of TIENAM includes Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus faecalis, and Bacteroides fragilis , a diverse group of problem pathogens commonly resistant to other antibiotics. TIENAM is resistant to degradation by bacterial beta- lactamases, which makes it active against a high percentage of organisms such as Pseudomonas aeruginosa, Serratia spp., and Enterobacter spp., which are inherently resistant to most beta - lactam antibiotics. The antibacterial spectrum of TIENAM is broader than that of any other antibiotic studied and includes virtually all clinically significant pathogens. Organisms against which TIENAM is usually active in vitro include: GRAM- NE Llegiu el document complet