CLAFORAN - PWS INJ 500MG/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:

500MG

फार्मास्यूटिकल फॉर्म:

POWDER FOR SOLUTION

रचना:

CEFOTAXIME SODIUM 500MG

प्रशासन का मार्ग:

INTRAMUSCULAR

पैकेज में यूनिट:

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

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

THIRD GENERATION CEPHALOSPORINS

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2012-12-31

उत्पाद विशेषताएं

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