JAMP AMOXI CLAV TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

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

Disponible depuis:

JAMP PHARMA CORPORATION

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 (CLAVULANATE POTASSIUM) 125MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

AMINOPENICILLINS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-11-20

Résumé des caractéristiques du produit

JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 1
of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP AMOXI CLAV
Amoxicillin and Clavulanate Potassium Tablets
JAMP Amoxi Clav -250 tablets
250 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -500F tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
JAMP Amoxi Clav -875 tablets
875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
House Standard
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 20, 2020
Date of Revision:
August 3, 2023
Submission Control Number: 272812
JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 2
of 37
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
...............................