CEFTRIAXONE FOR INJECTION USP 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:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G

Administration route:

INTRAMUSCULAR

Units in package:

10X(IM:4ML/2.8ML/IV:10.1ML)

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-06-28

Summary of Product characteristics

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
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Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
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Date of Revision:
November 09, 2018
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_Manufactured by:_
PFIZER HEALTHCARE INDIA PVT. LTD.
Irungattukottai - 602 105
India
_Distributed by: _
APOTEX INC.
150 Signet Drive
Toronto, ON, M9L 1T9
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Control number: 220666
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_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