Country: Canada
Language: English
Source: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
HOFFMANN-LA ROCHE LIMITED
J01DD04
CEFTRIAXONE
250MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG
INTRAMUSCULAR
0.9 ML 1M
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; AHFS:
CANCELLED POST MARKET
2012-06-20
PRODUCT MONOGRAPH ROCEPHIN ® (sterile ceftriaxone sodium) 0.25, 1 g ceftriaxone per vial Antibiotic Hoffmann-La Roche Limited Date of Preparation: 2455 Meadowpine Boulevard June 16, 1987 Mississauga, Ontario L5N 6L7 www.rochecanada.com Date of Revision: February 9, 2010 Control Number: 134328 ® Registered Trademark of Hoffmann-La Roche Limited © Copyright 1987-2010, Hoffmann-La Roche Limited ROCEPHIN ® PAGE 3 PRODUCT MONOGRAPH ROCEPHIN ® (Sterile Ceftriaxone Sodium) 0.25, 1 g ceftriaxone per vial Antibiotic ACTION _In vitro _studies indicate that the bactericidal action of ceftriaxone results from the inhibition of cell-wall synthesis. In E.coli , ceftriaxone showed a high affinity for penicillin binding proteins (PBP) 1a and 3 and a moderate affinity for 1b and 2. In H. influenzae, the highest affinity was shown for PBP 4 and PBP 5. The binding affinity to PBP 4 was 35-fold that of PBP 3, 10-fold that of PBP 2 and approximately 100-fold that of PBP 1. The morphological changes resulting from the PBP binding include filament formation or cell wall and septal thickening, and then cell lysis. INDICATIONS AND CLINICAL USES The treatment of the following infections when caused by susceptible strains of the designated micro-organisms: Lower Respiratory tract infections caused by E. coli, H. influenzae, K. pneumoniae and species, Staph. aureus, Strep. pneumoniae and species (excluding enterococci). Urinary tract infections (complicated and uncomplicated) caused by E. coli, Klebsiella species, P. mirabilis and P. vulgaris. Bacterial Septicemia caused by E. coli, H. influenzae, K. pneumoniae, Staph. aureus and Strep. pneumoniae, (excluding enterococci). Skin and Skin Structure Infections caused by K. pneumoniae and species, P. mirabilis, Staph. aureus, Staph. epidermidis and Streptococcus species (excluding enterococci). Bone and Joint Infections caused by Staph. aureus, Strep. pneumoniae and Streptococcus species (excluding enterococci). Intra-Abdominal Infections caused by E.coli and K. pneumoniae. Meningitis c Read the complete document