MYL-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Disponível em:

MYLAN PHARMACEUTICALS ULC

Código ATC:

A02BC05

DCI (Denominação Comum Internacional):

ESOMEPRAZOLE

Dosagem:

20MG

Forma farmacêutica:

TABLET (DELAYED-RELEASE)

Composição:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

PROTON-PUMP INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0145162001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2018-07-26

Características técnicas

_MYL-ESOMEPRAZOLE (esomeprazole) _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR MYL-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium
trihydrate), Oral
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUL 26, 2018
Date of Revision:
JUN 22, 2023
Submission Control Number: 271970
_MYL-ESOMEPRAZOLE (esomeprazole) _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNINGS AND PRECAUTIONS, General
06/2023
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and
Mutagenesis
06/2023
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.