CEFTRIAXONE FOR INJECTION USP POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

J01DD04

INN (International Adı):

CEFTRIAXONE

Doz:

10G

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 10G

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

95ML

Reçete türü:

Prescription

Terapötik alanı:

THIRD GENERATION CEPHALOSPORINS

Ürün özeti:

Active ingredient group (AIG) number: 0117292008; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2019-06-28

Ürün özellikleri

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE FOR INJECTION USP
250 MG, 1 G, 2 G AND 10 G CEFTRIAXONE PER VIAL
(AS CEFTRIAXONE SODIUM)
Sterile Powder
ANTIBIOTIC
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Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
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Date of Revision:
November 09, 2018
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_Manufactured by:_
PFIZER HEALTHCARE INDIA PVT. LTD.
Irungattukottai - 602 105
India
_Distributed by: _
APOTEX INC.
150 Signet Drive
Toronto, ON, M9L 1T9
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Control number: 220666
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_Product Monograph – _
_Pr_
_Ceftriaxone for Injection USP _
_Page 2 of 56_
PRODUCT MONOGRAPH
PR
CEFTRIAXONE FOR INJECTION USP
250 MG, 1 G, 2 G AND 10 G CEFTRIAXONE PER VIAL
(AS CEFTRIAXONE SODIUM)
Sterile Powder
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).
Skin and Skin Structure Infections caused by K. pneumoniae and
species, P. mirabilis,
Staph. aureus, Staph. epidermidis and Streptococcus