Страна: Канада
Език: английски
Източник: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
PFIZER CANADA ULC
J01DD04
CEFTRIAXONE
250MG
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG
INTRAMUSCULAR
10X(IM:1ML/IV:2.5ML)
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; AHFS:
CANCELLED POST MARKET
2019-06-28
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFTRIAXONE FOR INJECTION USP 250 MG, 1 G, 2 G AND 10 G CEFTRIAXONE PER VIAL (AS CEFTRIAXONE SODIUM) Sterile Powder ANTIBIOTIC _ _ _ _ _ _ _ _ _ _ _ _ _ _ Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 _ _ Date of Revision: November 09, 2018 _ _ _ _ _Manufactured by:_ PFIZER HEALTHCARE INDIA PVT. LTD. Irungattukottai - 602 105 India _Distributed by: _ APOTEX INC. 150 Signet Drive Toronto, ON, M9L 1T9 _ _ Control number: 220666 _ _ _ _ _Product Monograph – _ _Pr_ _Ceftriaxone for Injection USP _ _Page 2 of 56_ PRODUCT MONOGRAPH PR CEFTRIAXONE FOR INJECTION USP 250 MG, 1 G, 2 G AND 10 G CEFTRIAXONE PER VIAL (AS CEFTRIAXONE SODIUM) Sterile Powder 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). Skin and Skin Structure Infections caused by K. pneumoniae and species, P. mirabilis, Staph. aureus, Staph. epidermidis and Streptococcus Прочетете целия документ