GENTAMICIN SULFATE IN NACL 0.9% INJ SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GENTAMICIN (GENTAMICIN SULFATE); SODIUM CHLORIDE

제공처:

HOSPIRA HEALTHCARE ULC

ATC 코드:

J01GB03

INN (국제 이름):

GENTAMICIN

복용량:

1.2MG; 9MG

약제 형태:

SOLUTION

구성:

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

관리 경로:

INTRAVENOUS

패키지 단위:

50ML

처방전 유형:

Prescription

치료 영역:

AMINOGLYCOSIDES

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2011-08-05

제품 특성 요약

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