JAMP-AMOXICILLIN POWDER FOR SUSPENSION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponible desde:

JAMP PHARMA CORPORATION

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:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2023-03-10

Ficha técnica

JAMP-Amoxicillin Product Monograph Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-AMOXICILLIN
Amoxicillin Powder for Oral Suspension
Suspension, 250 mg / 5 mL amoxicillin (as amoxicillin trihydrate)
after reconstitution, Oral
House Standard
Antibiotic
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
March 10, 2023
Date of Revision:
MAR 15, 2024
Submission Control Number: 279419
JAMP-Amoxicillin Product Monograph Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS, Cardiovascular
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
02/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
……………………………………………………………………………………….
2
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
……………………………….…. 7
4.3
Reconstitution
...................................................................................................