ROCEPHIN PWS 2GM/VIAL POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Administration route:

INTRAMUSCULAR

Units in package:

19.2 ML IV

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2009-07-29

Summary of Product characteristics

PRODUCT MONOGRAPH
ROCEPHIN
®
(Sterile Ceftriaxone Sodium)
0.25, 1, 2, 10 g ceftriaxone per vial
Antibiotic
Hoffmann-La Roche Limited
DATE OF REVISION:
2455 Meadowpine Boulevard
AUGUST 20, 2009
Mississauga, Ontario
L5N 6L7
www.rochecanada.com
CONTROL NUMBER: 130114
®
Registered Trademark of Hoffmann-La Roche
Limited
©
Copyright 1987-2009, Hoffmann-La Roche
Limited
ROCEPHIN
®
„ PAGE 3
PRODUCT
MONOGRAPH
ROCEPHIN
®
(Sterile Ceftriaxone Sodium)
0.25, 1, 2, 10 g 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-Abdominal Infections caused by E.coli and K. pneumoniae.
Meningitis caused by H. influenzae