MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VERAPAMIL HYDROCHLORIDE

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

C08DA01

DCI (Dénomination commune internationale):

VERAPAMIL

Dosage:

120MG

forme pharmaceutique:

TABLET (EXTENDED-RELEASE)

Composition:

VERAPAMIL HYDROCHLORIDE 120MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-07-03

Résumé des caractéristiques du produit

_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
...............................