AURO-AMOXICILLIN CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

MAH:

AURO PHARMA INC

ATC_code:

J01CA04

INN:

AMOXICILLIN

dosage:

250MG

pharmaceutical_form:

CAPSULE

composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

administration_route:

ORAL

units_in_package:

30/100/500

prescription_type:

Prescription

therapeutic_area:

AMINOPENICILLINS

leaflet_short:

Active ingredient group (AIG) number: 0131314001; AHFS:

authorization_status:

APPROVED

authorization_date:

2012-06-27

SPC

Auro-Amoxicillin Product Monograph
Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Auro-Amoxicillin
Amoxicillin Capsules
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
BP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
JUN 27, 2012
Date of Revision:
NOV 02, 2023
Submission Control Number: 276668
Auro-Amoxicillin Product Monograph
Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
...............................................................................................................................
4
1.2 Geriatrics
...............................................................................................................................
4
2. CONTRAINDICATIONS
........................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.....................................................................
5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 Dosing Considerations
...........................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment Usual Dosage
............................................... 5
4.4 Administration
.......................................................................................................................
7
4.5 Missed Dose
..........................................................................................................................
7
5 OVERDOSAGE
....