CEFTRIAXONE SODIUM FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Διαθέσιμο από:

NOVOPHARM LIMITED

Φαρμακολογική κατηγορία (ATC):

J01DD04

INN (Διεθνής Όνομα):

CEFTRIAXONE

Δοσολογία:

2G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

THIRD GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2015-10-16

Αρχείο Π.Χ.Π.

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