Country: Canada
Language: English
Source: Health Canada
CEFOTAXIME SODIUM
SANOFI-AVENTIS CANADA INC
J01DD01
CEFOTAXIME
500MG
POWDER FOR SOLUTION
CEFOTAXIME SODIUM 500MG
INTRAMUSCULAR
10 VIALS (IM:2.2ML/IV:10.2ML/IV INF.:50 TO 1000ML)
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0152507003; AHFS:
CANCELLED POST MARKET
2012-12-31
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 Read the complete document