CLAFORAN - PWS INJ 2.0G/VIAL POWDER FOR SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

CEFOTAXIME SODIUM

थमां उपलब्ध:

SANOFI-AVENTIS CANADA INC

ए.टी.सी कोड:

J01DD01

INN (इंटरनेशनल नाम):

CEFOTAXIME

डोज़:

2G

फार्मास्यूटिकल फॉर्म:

POWDER FOR SOLUTION

रचना:

CEFOTAXIME SODIUM 2G

प्रशासन का मार्ग:

INTRAMUSCULAR

पैकेज में यूनिट:

IM:6ML/IV:11ML/IV INF.:56ML TO 1011ML; 10X2G

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

THIRD GENERATION CEPHALOSPORINS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0152507002; AHFS:

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2017-11-24

उत्पाद विशेषताएं

PRODUCT MONOGRAPH
PR
CLAFORAN
®
Cefotaxime for injection, Mfr. Std.
1g and 2g cefotaxime (as cefotaxime sodium) per vial
β-lactam Antibiotic
sanofi-aventis Canada Inc.
2905 Place Louis-R-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
November 12, 2014
Submission Control No.: 176886
s-a Version dated
2
PRODUCT MONOGRAPH
PR
CLAFORAN
®
Cefotaxime for injection, Mfr. Std.
1g and 2g cefotaxime (as cefotaxime sodium) per vial
β-lactam Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
CLAFORAN (cefotaxime for injection) 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 for injection) 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