MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

VERAPAMIL HYDROCHLORIDE

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C08DA01

Designación común internacional (DCI):

VERAPAMIL

Dosis:

120MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

VERAPAMIL HYDROCHLORIDE 120MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0113846001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2009-07-03

Ficha técnica

_Mylan-Verapamil_
_ _
_SR (verapamil hydrochloride) Product Monograph_
_ _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-VERAPAMIL SR
Verapamil hydrochloride sustained-release tablets
Sustained-release tablets, 120 mg, 180 mg and 240 mg, oral
Mylan Standard
_ _
Antihypertensive Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control Number: 263850
Date of
Initial
Authorization:
February 12, 1996
Date of
Revision:
June 10,
2022
_ _
_Mylan-Verapamil _
_ _
_SR (verapamil hydrochloride) Product Monograph_
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
...............................