Kraj: Kanada
Język: angielski
Źródło: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
PFIZER CANADA ULC
J01DD04
CEFTRIAXONE
2G
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G
INTRAMUSCULAR
10X50ML VIAL
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292002; AHFS:
CANCELLED POST MARKET
2021-03-24
PRODUCT MONOGRAPH Including Patient Medication Information Pr Ceftriaxone Sodium for Injection BP 250 mg, 500 mg, 1 g , 2 g, 10 g ceftriaxone per vial STERILE POWDER FOR SOLUTION Antibiotic Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: October 21, 2020 Control number: 244382 _Product Monograph - _ _Pr_ _Ceftriaxone Sodium for Injection BP _ _Page 2 of 67 _ PRODUCT MONOGRAPH Pr Ceftriaxone Sodium for Injection BP 250 mg, 500 mg, 1 g , 2 g, 10 g ceftriaxone per vial STERILE POWDER FOR SOLUTION 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 USE 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). _Product Monograph - _ _Pr_ _Ceftriaxone Sodium for Injection BP _ _Page 3 of 67 _ 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 Przeczytaj cały dokument