CLAFORAN - PWS INJ 500MG/VIAL POWDER FOR SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CEFOTAXIME SODIUM

Disponibbli minn:

SANOFI-AVENTIS CANADA INC

Kodiċi ATC:

J01DD01

INN (Isem Internazzjonali):

CEFOTAXIME

Dożaġġ:

500MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

CEFOTAXIME SODIUM 500MG

Rotta amministrattiva:

INTRAMUSCULAR

Unitajiet fil-pakkett:

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

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

THIRD GENERATION CEPHALOSPORINS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2012-12-31

Karatteristiċi tal-prodott

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