AURO-AMOXICILLIN POWDER FOR SUSPENSION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponible desde:

AURO PHARMA INC

Código ATC:

J01CA04

Designación común internacional (DCI):

AMOXICILLIN

Dosis:

250MG

formulario farmacéutico:

POWDER FOR SUSPENSION

Composición:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Vía de administración:

ORAL

Unidades en paquete:

100ML/150ML

tipo de receta:

Prescription

Área terapéutica:

AMINOPENICILLINS

Resumen del producto:

Active ingredient group (AIG) number: 0131314003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-11-03

Ficha técnica

Auro-Amoxicillin Product Monograph
Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-AMOXICILLIN
AMOXICILLIN FOR ORAL SUSPENSION
Powder for Suspension, 125 mg / 5 mL and 250 mg/5 ml amoxicillin (as
amoxicillin
trihydrate) after reconstitution, Oral
USP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
NOV 03, 2016
Date of Revision:
December 05, 2023
Submission Control Number: 276656
Auro-Amoxicillin Product Monograph
Page 2 of 29
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
12/2023
7 WARNINGS AND PRECAUTIONS 7.1.4 Geriatrics
12/2023
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
.....................................................................
5
4.3 Reconstitution
.....................................................................................................................
7
4.4 Administratio