AJ-TOBRAMYCIN LIQUID

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
30-04-2012

有効成分:

TOBRAMYCIN

から入手可能:

AGILA JAMP CANADA INC

ATCコード:

J01GB01

INN(国際名):

TOBRAMYCIN

投薬量:

40MG

医薬品形態:

LIQUID

構図:

TOBRAMYCIN 40MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

10X2ML/30ML

処方タイプ:

Prescription

治療領域:

AMINOGLYCOSIDES

製品概要:

Active ingredient group (AIG) number: 0110230001; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2015-11-03

製品の特徴

                                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
                                
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