CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

J01DD04

INN (nume internaţional):

CEFTRIAXONE

Dozare:

2G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10X50ML VIAL

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THIRD GENERATION CEPHALOSPORINS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2021-03-24

Caracteristicilor produsului

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