FORTAZ POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE)

Disponible desde:

GLAXOSMITHKLINE INC

Código ATC:

J01DD02

Designación común internacional (DCI):

CEFTAZIDIME

Dosis:

2G

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE) 2G

Vía de administración:

INTRAVENOUS

Unidades en paquete:

2G DOSE X 10

tipo de receta:

Prescription

Área terapéutica:

THIRD GENERATION CEPHALOSPORINS

Resumen del producto:

Active ingredient group (AIG) number: 0116900008; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-12-21

Ficha técnica

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_Page 1 of 74_
PRODUCT MONOGRAPH
PR
FORTAZ
ceftazidime for injection, USP
ANTIBIOTIC
GlaxoSmithKline Inc.
7333 Mississauga Rd
Mississauga, Ontario
L5N 6L4
Date of Revision:
August 16, 2018
Control Number: 213619
_©2018 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
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_Page 2 of 74_
PRODUCT MONOGRAPH
PR
FORTAZ
ceftazidime for injection, USP
ANTIBIOTIC
CLINICAL PHARMACOLOGY
_In vitro_ studies indicate that the bactericidal action of
ceftazidime, a semisynthetic
cephalosporin antibiotic, results from inhibition of bacterial cell
wall synthesis.
Ceftazidime has a high affinity for the Penicillin-Binding Protein-3
(PBP-3) and moderate
affinity for the PBP-1a of certain Gram negative organisms such as
_Escherichia_ _coli_ and
_Pseudomonas aeruginosa_. The affinity for PBP-1b is much less than
that for either
PBP-3 or PBP-1a. PBP-3 is involved in the process of cross-wall
formation (septation).
Binding to this protein results in formation of filaments and eventual
death of the
bacterium. PBP-1a and PBP-1b are involved in longitudinal wall
synthesis (elongation)
prior to septation. Binding to these proteins results in spheroplast
formation followed by
rapid lysis.
Ceftazidime has high affinity for PBP-1 and PBP-2 of _Staphylococcus
aureus_. However,
the drug's affinity for PBP-3 is very much less in this organism.
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_Page 3 of 74_
INDICATIONS AND CLINICAL USE
FORTAZ (ceftazidime for injection) may be indicated for the treatment
of patients with
infections caused by susceptible strains of the designated organisms
in the following
diseases:
LOWER RESPIRATORY TRACT INFECTIONS
Pneumonia caused by _Pseudomonas aeruginosa_; _Haemophilus influenzae_
including
ampicillin-resistant strains; _Klebsiella_ species; _Enterobacter
_species; _Proteus mirabilis; _
_Escherichia coli, Serratia_ species, _Streptococcus pneumoniae_, and
_Staphylococcus _
_aureus_ (methicillin susceptible) strains.
URINARY TRACT INFECTIONS
Caused by _Pseudomonas aeruginosa; E