Riik: Kanada
keel: inglise
Allikas: Health Canada
QUINUPRISTIN; DALFOPRISTIN
MONARCH PHARMACEUTICALS IRELAND LIMITED
J01FG02
QUINOPRISTIN AND DALFOPRISTIN
150MG; 350MG
POWDER FOR SOLUTION
QUINUPRISTIN 150MG; DALFOPRISTIN 350MG
INTRAVENOUS
1/10VIALS
Prescription
STREPTOGRAMINS
Active ingredient group (AIG) number: 0239201001; AHFS:
CANCELLED POST MARKET
2008-05-28
PRODUCT MONOGRAPH Pr SYNERCID TM (quinupristin 150 mg) (dalfopristin 350 mg) Powder for Intravenous Injection Antibacterial Agent Monarch Pharmaceuticals Ireland Limited Date of preparation: (Subsidiary of King Pharmaceuticals, Inc., October 21, 2005 Bristol, Tennesee) Alexandra House, The Sweepstakes, Ballsbridge Dublin 4 Ireland Control#: 101819 _Synercid_ _®_ _Quinupristin, 150 mg _ _Dalfopristin, 350 mg _ _ _ Powder for injection For intravenous infusion only _ _ THERAPEUTIC CLASSIFICATION Antibacterial agent ACTION and CLINICAL PHARMACOLOGY Action SYNERCID (quinupristin and dalfopristin in the ratio of 30:70) is a streptogramin antibacterial agent for intravenous administration. The streptogramin components of SYNERCID, quinupristin and dalfopristin, individually possess bacteriostatic activity against Gram-positive bacteria, as do the principal components, PI and PIIA, of the naturally occurring streptogramin, pristinamycin. The main target of quinupristin and dalfopristin is the bacterial ribosome. When combined, quinupristin and dalfopristin, as SYNERCID, exert bactericidal activity by inhibiting early and late phases of bacterial protein synthesis and interact synergistically at the ribosomal site so that SYNERCID's activity is much greater than that of the components individually. The mode of action of streptogramins, _e.g., _SYNERCID, differs somewhat from that of the macrolides and lincosamides. SYNERCID differs in chemical structure and mode of action from other classes of antimicrobial agents such β-lactams, glycopeptides and quinolone antibiotics. Therefore, microorganisms resistant to these latter classes of antimicrobial agents may be susceptible to SYNERCID. SYNERCID is bacteriostatic against _Enterococcus faecium _and bactericidal against strains of methicillin susceptible _staphylococci. _ A prolonged post-antibiotic effect (PAE) of SYNERCID was observed with _Staphylococcus _ _aureus _(10 hours) and _Streptococcus pneumoniae _(9.1 hours) in the neutropenic mouse thigh abscess model, support Lugege kogu dokumenti