Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
NOVOPHARM LIMITED
J01DD04
CEFTRIAXONE
0.25G
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 0.25G
INTRAMUSCULAR
100
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292001; AHFS:
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH PR CEFTRIAXONE SODIUM FOR INJECTION (Sterile Ceftriaxone Sodium) 0.25 g, 1 g, 2 g, 10 g per vial Novopharm Standard Antibiotic Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Control No: 140485 Date of Revision: November 5, 2010 _Page 2 of 51 _ PRODUCT MONOGRAPH Pr CEFTRIAXONE SODIUM FOR INJECTION (Sterile Ceftriaxone Sodium) 0.25 g, 1 g, 2 g, 10 g ceftriaxone per vial Novopharm Standard 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). _Page 3 of 51 _ Intra-Abdominal Infections caused by E.coli and K. pneumoniae. Meningitis caused by H. influenzae, N. meningitidis, and Strep. pneumoniae. Ceftria Baca dokumen lengkap