Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
CEFUROXIME (CEFUROXIME SODIUM)
PHARMACEUTICAL PARTNERS OF CANADA INC
J01DC02
CEFUROXIME
7.5G
POWDER FOR SOLUTION
CEFUROXIME (CEFUROXIME SODIUM) 7.5G
INTRAVENOUS
77ML
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0122448003; AHFS:
CANCELLED POST MARKET
2008-02-15
PRODUCT MONOGRAPH PR CEFUROXIME FOR INJECTION USP 750 mg, 1.5 g, and 7.5 g cefuroxime ANTIBIOTIC Pharmaceutical Partners of Canada Inc. Date of Preparation: 45 Vogell Road, Suite 200 February 6, 2008 Richmond Hill, ON L4B 3P6 Control No.: 119563 Page 2 of 46 CEFUROXIME FOR INJECTION USP 750 mg, 1.5 g, and 7.5 g cefuroxime THERAPEUTIC CLASSIFICATION Antibiotic ACTION AND CLINICAL PHARMACOLOGY _In vitro _ studies demonstrate that the bactericidal action of cefuroxime results from inhibition of bacterial cell wall synthesis by inhibiting the transpeptidase and carboxypeptidase enzymes. INDICATIONS AND CLINICAL USES TREATMENT Cefuroxime for Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: LOWER RESPIRATORY TRACT INFECTIONS Pneumonia caused by _Streptococcus pneumoniae_, _Haemophilus influenzae_ including ampicillin-resistant strains, _Klebsiella_ species, _Staphylococcus _ _aureus _ including ampicillin-resistant (but not methicillin-resistant) strains, _Streptococcus pyogenes_, and _Escherichia coli_. Page 3 of 46 URINARY TRACT INFECTIONS Caused by _Escherichia coli _and _Klebsiella _species. SOFT TISSUE INFECTIONS Caused by _ Staphylococcus aureus _ including ampicillin-resistant (but not methicillin- resistant) strains, _Streptococcus pyogenes_, _Escherichia coli_, _Klebsiella _species. MENINGITIS Caused by _ Staphylococcus aureus _ including ampicillin-resistant (but not methicillin- resistant) strains, _Streptococcus pneumoniae_, _Haemophilus influenzae_, and _Neisseria _ _meningitidis_. GONORRHOEA Caused by _Neisseria gonorrhoea _including ampicillin-resistant strains. BONE AND JOINT INFECTIONS Caused by _Staphylococcus _ _aureus _ (penicillinase and non-penicillinase producing strains). Specimens for bacteriologic culture should be obtained prior to therapy in order to identify the causative organisms and to determine their susceptibility to cefuroxime. Therapy may be instituted before results of suscep Aqra d-dokument sħiħ