NOVAMOXIN CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

J01CA04

Designación común internacional (DCI):

AMOXICILLIN

Dosis:

500MG

formulario farmacéutico:

CAPSULE

Composición:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

Vía de administración:

ORAL

Unidades en paquete:

100/250/500/1000

tipo de receta:

Prescription

Área terapéutica:

AMINOPENICILLINS

Resumen del producto:

Active ingredient group (AIG) number: 0131314006; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-06-03

Ficha técnica

NOVAMOXIN
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR NOVAMOXIN
AMOXICILLIN CAPSULES, USP
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
AMOXICILLIN CHEWABLE TABLETS, USP
Tablets, 250 mg amoxicillin (as amoxicillin trihydrate), Oral
AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP
Suspension, 250 mg/5 ml amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION, Teva Standard
Suspension, 250 mg/5 ml amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
Antibiotic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court February 9, 1979
Toronto, ON
M1B 2K9 Date of Revision:
Canada May 16, 2023
www.tevacanada.com
Submission Control Number: 268379
NOVAMOXIN
2
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
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
......