RATIO-ACLAVULANATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (POTASSIUM CLAVULANATE)

Disponible depuis:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Code ATC:

J01CR02

DCI (Dénomination commune internationale):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

250MG; 125MG

forme pharmaceutique:

TABLET

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG; CLAVULANIC ACID (POTASSIUM CLAVULANATE) 125MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

AMINOPENICILLINS

Descriptif du produit:

Active ingredient group (AIG) number: 0234720008; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2009-07-17

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
RATIO-ACLAVULANATE
RATIO-ACLAVULANATE
125F
RATIO-ACLAVULANATE
250F
amoxicillin : clavulanic acid
Tablets and Oral Suspension
Manufacturer’s Standard
ANTIBIOTIC &
$
-LACTAMASE INHIBITOR
RATIOPHARM INC
17 800 LAPOINTE
MIRABEL, QUEBEC
CANADA, J7J 1P3
D-1036-3
CONTROL #: 111634
DATE
OF
PREPARATION:
MAY 27, 2002
DATE OF REVISION:
FEBRUARY 12, 2007
Page
2
PRODUCT MONOGRAPH
RATIO-ACLAVULANATE
RATIO-ACLAVULANATE
125F
RATIO-ACLAVULANATE
250F
amoxicillin : clavulanic acid
Tablets and Oral Suspension
Manufacturer’s Standard
ANTIBIOTIC AND
$
-LACTAMASE INHIBITOR
ACTION
Amoxicillin exerts a bactericidal action against sensitive organisms
during the stage
of active multiplication through the inhibition of the biosynthesis of
bacterial cell wall
mucopeptides.
Clavulanic
acid
inhibits
specific
$
-lactamases
of
some
microorganisms and allows amoxicillin to inhibit amoxicillin
(ampicillin) resistant
organisms which produce clavulanic acid sensitive beta
$
-lactamases.
INDICATIONS AND CLINICAL USE
RATIO-ACLAVULANATE (amoxicillin : clavulanic acid) is indicated for
the treatment
of the following infections when caused by ratio-ACLAVULANATE
susceptible
strains of the designated bacteria:
•
Upper Respiratory Tract Infections when caused by
$
-lactamase producing
strains of _S. aureus._
•
Sinusitis when caused by
$
-lactamase producing strains of _ H. influenzae_ or
_Moraxella (Branhamella) catarrhalis._
Page
3
•
Otitis Media when caused by
$
-lactamase producing strains of _H. influenzae_ or
_Moraxella (Branhamella) catarrhalis_.
•
Lower Respiratory Tract Infections when caused by
$
-lactamase producing
strains of _H. influenzae, K. pneumoniae, S. aureus_ or_ Moraxella
(Branhamella)_
_catarrhalis_.
•
Skin and Soft Tissue Infections when caused by
$
-lactamase producing strains
of _S. aureus._
•
Urinary Tract Infections when caused by
$
-lactamase producing strains of _ E._
_coli_, _P. mirabilis or Klebsiella _species_._
While RATIO-ACLAVULANATE is indicated only for the conditions listed
above,
infect