AURO-AMOXICLAV TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

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

Tilgjengelig fra:

AURO PHARMA INC

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosering :

875MG; 125MG

Legemiddelform:

TABLET

Sammensetning:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 875MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

AMINOPENICILLINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0234720005; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-01-09

Preparatomtale

_AURO-AMOXICLAV PRODUCT MONOGRAPH _ Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-AMOXICLAV
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
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
April 03, 1984
Date of Revision:
June 7, 2023
Submission Control Number: 271369
_AURO-AMOXICLAV PRODUCT MONOGRAPH _ Page 2 of 34
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
06/2023
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
.......................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................................................................
5
4.4 Administration
............................