CLAFORAN - PWS INJ 500MG/VIAL POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CEFOTAXIME SODIUM

제공처:

SANOFI-AVENTIS CANADA INC

ATC 코드:

J01DD01

INN (International Name):

CEFOTAXIME

복용량:

500MG

약제 형태:

POWDER FOR SOLUTION

구성:

CEFOTAXIME SODIUM 500MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

10 VIALS (IM:2.2ML/IV:10.2ML/IV INF.:50 TO 1000ML)

처방전 유형:

Prescription

치료 영역:

THIRD GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0152507003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2012-12-31

제품 특성 요약

PRODUCT MONOGRAPH
PR
CLAFORAN
®
(sterile cefotaxime sodium, 500 mg, 1g, 2 g)
β-lactam Antibiotic
SANOFI-AVENTIS CANADA INC.
2150 ST. ELZEAR BLVD. WEST
LAVAL, QUEBEC H7L 4A8
DATE OF REVISION:
November 25, 2010
SUBMISSION CONTROL NO.: 142035
2
PRODUCT MONOGRAPH
PR
CLAFORAN
®
(sterile cefotaxime sodium, 500 mg, 1g, 2 g)
β-lactam Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
CLAFORAN (cefotaxime sodium) is a semi-synthetic, 2-aminothiazolyl
cephalosporin antibiotic
for parenteral use. _In vitro _studies indicate that the antibacterial
action of CLAFORAN results
from inhibition of cell wall synthesis. It is stable against the
action of most β-lactamases.
INDICATIONS AND CLINICAL USE
TREATMENT
_ _
_ _
CLAFORAN (cefotaxime sodium) may be indicated for the treatment of
infections caused by
susceptible strains of the designated micro-organisms in the diseases
listed below.
LOWER RESPIRATORY TRACT INFECTIONS:
Pneumonia
and
lung
abscess
caused
by
_Streptococcus _
_pneumoniae_
(formerly
_Diplococcus_
_pneumoniae_), other streptococci (excluding enterococci, e.g. _S.
faecalis_),_ Staphylococcus_ _aureus_
(penicillinase
and
non-penicillinase
producing),_ _
_Escherichia _
_coli_,_ _
_Hemophilus _
_influenzae_,
(including ampicillin resistant strains) and unspecified _Klebsiella_
species.
URINARY TRACT INFECTIONS:
Caused by _Escherichia coli_, unspecified _Klebsiella_ species
(including _K. pneumoniae_),_ Proteus_
_mirabilis_, indole positive _Proteus_, _Serratia marcescens_ and
_Staphylococcus epidermidis_. Also,
uncomplicated gonorrhea caused by _N. gonorrhoeae_ including
penicillin resistant strains.
BACTEREMIA/SEPTICEMIA:
Caused by _Escherichia coli_, unspecified _Klebsiella_ strains and
_Serratia marcescens_.
SKIN INFECTIONS:
Caused
by
_Staphylococcus _
_aureus_
(penicillinase
and
non-penicillinase
producing),
_S. epidermidis_, group A streptococci, _ Escherichia coli_, _ Proteus
mirabilis_ and indole positive
_Proteus_.
INTRA-ABDOMINAL INFECTIONS:
Caused by _Escherichia coli_, and unspecified _Klebsiella_ species.
GYNEC