TOBRAMYCIN INJECTION, USP SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TOBRAMYCIN

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

J01GB01

INN (Kansainvälinen yleisnimi):

TOBRAMYCIN

Annos:

40MG

Lääkemuoto:

SOLUTION

Koostumus:

TOBRAMYCIN 40MG

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

2ML/30ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

AMINOGLYCOSIDES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2022-01-06

Valmisteyhteenveto

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_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR TOBRAMYCIN INJECTION, USP
40 mg Tobramycin/mL
Antibiotic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: July 26, 2018
Submission Control No: 217705
_ _
_Page 2 of 24_
PR
TOBRAMYCIN INJECTION, USP
40 mg Tobramycin/mL
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
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
Tobramycin Injection, USP 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)
Tobramycin Injection, USP may be considered in serious staphylococcal
infections when
penicillin or other potentially less toxic drugs are contraindicated
and when bacterial
susceptibility testing and clinical judgement indicate its use.
Appropriate sensitivity studies should be performed to determi