CEFTRIAXONE SODIUM FOR INJECTION POWDER FOR SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Доступно од:

NOVOPHARM LIMITED

АТЦ код:

J01DD04

INN (Међународно име):

CEFTRIAXONE

Дозирање:

0.25G

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 0.25G

Пут администрације:

INTRAMUSCULAR

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

THIRD GENERATION CEPHALOSPORINS

Резиме производа:

Active ingredient group (AIG) number: 0117292001; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2015-10-16

Карактеристике производа

PRODUCT MONOGRAPH
PR
CEFTRIAXONE SODIUM FOR INJECTION
(Sterile Ceftriaxone Sodium)
0.25 g, 1 g, 2 g, 10 g per vial
Novopharm Standard
Antibiotic
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No: 140485
Date of Revision:
November 5, 2010
_Page 2 of 51 _
PRODUCT MONOGRAPH
Pr
CEFTRIAXONE SODIUM FOR INJECTION
(Sterile Ceftriaxone Sodium)
0.25 g, 1 g, 2 g, 10 g ceftriaxone per vial
Novopharm Standard
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).
_Page 3 of 51 _
Intra-Abdominal Infections caused by E.coli and K. pneumoniae.
Meningitis caused by H. influenzae, N. meningitidis, and Strep.
pneumoniae. Ceftria