CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

PFIZER CANADA ULC

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Administration route:

INTRAMUSCULAR

Units in package:

10X50ML VIAL

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-03-24

Summary of Product characteristics

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