APO-AMOXI CLAV TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

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

Tilgjengelig fra:

APOTEX INC

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosering :

250MG; 125MG

Legemiddelform:

TABLET

Sammensetning:

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

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

AMINOPENICILLINS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2019-01-02

Preparatomtale

_APO-AMOXI CLAV (Amoxicillin and Clavulanate Potassium Tablets) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-AMOXI CLAV
Amoxicillin and Clavulanate Potassium Tablets, USP
Amoxicillin (as amoxicillin trihydrate) and Clavulanic acid (as
clavulanate potassium)
250 mg / 125 mg, 500 mg / 125 mg and 875 mg / 125 mg
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
APOTEX INC.
Date of Initial Authorization:
150 Signet Drive
January 2, 2019
Toronto, Ontario
M9L 1T9
Date of Revision:
January 16, 2024
Submission Control Number: 278582
_APO-AMOXI CLAV (Amoxicillin and Clavulanate Potassium Tablets) _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
01/2024
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
......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................... 5
4.4
Administration
.............................................