GENTAMICIN SULFATE IN NACL 0.9% INJ SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GENTAMICIN (GENTAMICIN SULFATE); SODIUM CHLORIDE

Pieejams no:

HOSPIRA HEALTHCARE ULC

ATĶ kods:

J01GB03

SNN (starptautisko nepatentēto nosaukumu):

GENTAMICIN

Deva:

1.2MG; 9MG

Zāļu forma:

SOLUTION

Kompozīcija:

GENTAMICIN (GENTAMICIN SULFATE) 1.2MG; SODIUM CHLORIDE 9MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

50ML

Receptes veids:

Prescription

Ārstniecības joma:

AMINOGLYCOSIDES

Produktu pārskats:

Active ingredient group (AIG) number: 0222855001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2011-08-05

Produkta apraksts

PRODUCT MONOGRAPH
GENTAMICIN SULFATE IN 0.9% SODIUM CHLORIDE INJECTION
60 mg, 70 mg, 80 mg and 100 mg gentamicin
in Flexible (PVC) Containers
Antibiotic
Hospira Healthcare Corporation
DATE OF PREPARATION:
5400 Côte-de-Liesse
May 13, 2004
Town of Mount Royal (QC), CANADA
H4P 1A5
Control No. 091537
PRODUCT MONOGRAPH
-2 -
NAME OF DRUG
GENTAMICIN SULFATE IN 0.9% SODIUM CHLORIDE INJECTION
60 mg, 70 mg, 80 mg and 100 mg gentamicin
in Flexible (PVC) Containers
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Gentamicin is a bactericidal antibiotic which affects bacterial growth
by specific inhibition
of normal protein synthesis in susceptible bacteria.
INDICATIONS AND CLINICAL USES
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in
the treatment of serious
infections caused by susceptible strains of the following
microorganisms: Pseudomonas
aeruginosa, Proteus species (both indole positive and indole
negative), Escherichia coli,
Klebsiella pneumoniae, Enterobacter aerogenes, Serratia marcescens and
Staphylococcus
species (including penicillin and methicillin resistant strains).
Gentamicin may be considered for treatment of:
1.
Bacteremia;
2.
Respiratory tract infections;
3.
Urinary tract infections;
4.
Infected wounds: surgical and traumatic;
5.
Soft tissue infections: including peritonitis and burns complicated by
sepsis;
6.
Bone Infections
-3 -
In suspected or documented gram-negative septicemia, particularly when
shock or hypotension
is present, Gentamicin Sulfate in 0.9% Sodium Chloride Injection may
be considered for initial
antimicrobial therapy. Gentamicin should be considered in serious
Staphylococcus infections
when other less potentially toxic antimicrobial drugs are
contraindicated, or when bacterial
susceptibility testing and clinical judgement indicate its use. If a
mixed infection involving
anaerobic organism is suspected, additional antimicrobial therapy with
anaerobic activity should
be added to the gentamicin regimen.
Susceptibility
Appropriate culture and susceptibility studies should be