国: カナダ
言語: 英語
ソース: Health Canada
TOBRAMYCIN
AGILA JAMP CANADA INC
J01GB01
TOBRAMYCIN
40MG
LIQUID
TOBRAMYCIN 40MG
INTRAMUSCULAR
10X2ML/30ML
Prescription
AMINOGLYCOSIDES
Active ingredient group (AIG) number: 0110230001; AHFS:
CANCELLED PRE MARKET
2015-11-03
1 PRODUCT MONOGRAPH PR AJ-TOBRAMYCIN TOBRAMYCIN INJECTION USP 40 MG / ML ANTIBIOTIC AGILA-JAMP CANADA INC. DATE OF PREPARATION: 1380-203 Newton Street, April 30, 2012 Boucherville, QC, J4B 5H2 Control No. 155238 2 PRODUCT MONOGRAPH PR AJ-TOBRAMYCIN TOBRAMYCIN INJECTION USP 40 MG / ML THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTIONS AND CLINICAL PHARMOCOLOGY The bactericidal activity of tobramycin, like that of other aminoglycosides, is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria. However, at the present time, very little is known about the specific site(s) of this action. It is thought that inhibition of synthesis is due to an action on ribosomes that, in turn, causes bacterial misreading of messenger RNA. INDICATIONS AJ-Tobramycin may be indicated for the treatment of the following infections when caused by susceptible organisms: septicemia, complicated and recurrent urinary tract infections, lower respiratory infections, serious skin and soft tissue infections including burns and peritonitis and central nervous system infections caused by organisms resistant to antibiotics usually considered efficacious in these infections. Tobramycin is usually active against most strains of the following organisms _in vitro _and in clinical infections: • _Pseudomonas aeruginosa_ • _Proteus _ sp. (indole-positive and indole-negative), including _Proteus _ _mirabilis; _ _Morganella morganii, Providencia rettgeri, _and _Proteus vulgaris._ • _Escherichia coli_ • _Klebsiella-Enterobacter-Serratia _group • _Citrobacter _sp. • _Providencia _sp. • _Staphylococci, _ including _ Staphylococcus aureus _ (coagulase-positive and coagulase- negative) AJ-Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Appropriate sensitivity studies should be performed to determine the susceptibility of the causative organism to tob 完全なドキュメントを読む