국가: 캐나다
언어: 영어
출처: Health Canada
CEFTRIAXONE (CEFTRIAXONE SODIUM)
FRESENIUS KABI CANADA LTD
J01DD04
CEFTRIAXONE
10G
POWDER FOR SOLUTION
CEFTRIAXONE (CEFTRIAXONE SODIUM) 10G
INTRAVENOUS
100
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0117292008; AHFS:
APPROVED
2017-07-07
PRODUCT MONOGRAPH PR CEFTRIAXONE SODIUM FOR INJECTION BP (Sterile Ceftriaxone Sodium) 250 mg, 1 gram, 2 gram and 10 gram ceftriaxone per vial Antibiotic FRESENIUS KABI CANADA LTD. Date of Preparation: 165 Galaxy Blvd, Suite 100 July 5, 2017 Toronto, Ontario M9W 0C8 Submission Control No.: 205981 _Ceftriaxone Sodium for Injection-PM-ENG-v1.0 _ _ _ _Page 2 of 46 _ PRODUCT MONOGRAPH PR CEFTRIAXONE SODIUM FOR INJECTION BP (Sterile Ceftriaxone Sodium) Ceftriaxone Sodium for Injection BP 250 mg, 1 gram, 2 gram and 10 gram 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- 전체 문서 읽기