Land: Kanada
Tungumál: enska
Heimild: Health Canada
CEFOTAXIME (CEFOTAXIME SODIUM)
NOVOPHARM LIMITED
500MG
POWDER FOR SOLUTION
CEFOTAXIME (CEFOTAXIME SODIUM) 500MG
INTRAMUSCULAR
100
Schedule G (CDSA IV)
Active ingredient group (AIG) number: 0114953001
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH CEFOTAXIME FOR INJECTION USP (CEFOTAXIME SODIUM) ANTIBIOTIC Novopharm Limited 30 Novopharm Court Toronto, ON M1B 2K9 Control No. 141201 Date of Preparation: February 3, 1999 Date of Revision: December 2, 2010 2 PRODUCT MONOGRAPH CEFOTAXIME FOR INJECTION USP (CEFOTAXIME SODIUM) 500 MG, 1 G, AND 2 G CEFOTAXIME PER VIAL THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION AND CLINICAL PHARMACOLOGY CEFOTAXIME for Injection USP (cefotaxime sodium) is a third generation semisynthetic cephalosporin antibiotic. Cefotaxime exerts its bactericidal action through the inhibition of bacterial cell wall synthesis. Cefotaxime is an aminothiazolyl cephalosporin and contains an aminothiazolyl-acetyl side chain, with an alpha-syn-methoximino group at position 7 of the cephalosporin nucleus. The aminothiazolyl side chain enhances antibacterial activity, particularly against Enterobacteriaceae, and the methoximino group imparts stability against hydrolysis by many β-lactamases. INDICATIONS AND CLINICAL USE TREATMENT CEFOTAXIME for Injection USP (Cefotaxime sodium) may be indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. 1. Lower respiratory tract infections such as pneumonia and lung abscess when caused by _Streptococcus_ _pneumoniae_ , other streptococci (excluding enterococci, e.g. _S. faecalis_ ), _Staphylococcus aureus_ (penicillinase and non-penicillinase producing), _Escherichia coli_ , _Haemophilus influenzae_ (including ampicillin resistant strains) and unspecified _Klebsiella_ species. 2. 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 gonorrhoea caused by _N. gonorrhoeae_ including penicillin resistant strains. 3. Bacteremia/Septicemia caused by _Escherichia coli_ , unspecified _Klebsiella_ strains and _Serratia marcescens_ . 3 4. Skin in Lestu allt skjalið