CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Доступно од:

FRESENIUS KABI CANADA LTD

АТЦ код:

J01DD04

INN (Међународно име):

CEFTRIAXONE

Дозирање:

2G

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Пут администрације:

INTRAMUSCULAR

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

THIRD GENERATION CEPHALOSPORINS

Резиме производа:

Active ingredient group (AIG) number: 0117292006; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2017-07-07

Карактеристике производа

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-