国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MOXIFLOXACIN HYDROCHLORIDE
BAYER INDONESIA - Indonesia
MOXIFLOXACIN HYDROCHLORIDE
0.436 G
INFUS
DUS, 1 BOTOL @ 250 ML
FRESENIUS KABI ITALI S.R.L - Italy
2021-05-26
Avelox ® IV/Moxifloxacin HCl/infusion/CCDS#23/ BEC 18031-Fresenius Kabi 1 AVELOX ® IV ANTIBACTERIAL INFUSION SOLUTION FOR INTRAVENOUS INJECTION Important information, please read carefully! COMPOSITION 1 single bottle of 250 mL infusion solution containing 400 mg moxifloxacin (as hydrochloride). PROPERTIES PHARMACOLOGICAL PROPERTIES PHARMACODYNAMYC PROPERTIES PHARMACOTHERAPEUTIC GROUP: Quinolone antibacterials, fluoroquinolones ATC CODE: J01MA 14 Moxifloxacin is a fluoroquinolone antibacterial. MECHANISM OF ACTION _In vitro, _moxifloxacin has been shown to have activity against a wide range of Gram-positive and Gram-negative pathogens. The bacterial action results from the interference with topoisomerase II (DNA Gyrase) and IV. Topoisomerases are essential enzymes which play a crucial part in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is also known to influence bacterial chromosome division. Kinetic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate. Minimum bacterial concentrations (MBC) were found to be the range of the minimum inhibitory concentration (MIC). POOLED DATA OF PHARMACOKINETIC _ _ _AUC (MG.H/L) _ _C MAX (MG/L) _ _ _ _Moxifloxacin 400 mg i.v. single dose _ _ _ _First dose: _ _39.3 + 8.6 _ _within 60 minutes _ _3.9 + 0.9 _ _within 30 minutes _ _4.4 + 0.1 _ _ _ _Moxifloxacin 400 mg i.v. multiple dose _ _ _ _US study _ _38.0 _ _European study _ _48.2 _ _US study _ _4.1 _ _European study _ _6.0 _ INTERFERENCE WITH CULTURE TEST Moxifloxacin therapy may give false negative culture results for _ Mycobacterium spp_. By suppression of mycobacterial growth. Effect on the intestinal flora in humans The following changes in the intestinal flora were seen in volunteers following administration of moxifloxacin: _E. coli, Bacillus _ _spp_., _Enterococci,_ and _Klebsiella spp. _ were reduced, as were the anaerobes _Bacteroides vulgatus, Bifidobacterium_, _Eubacterium_, and _Peptostreptococcus_. For _B. fragilis_ there was an increas 阅读完整的文件