MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VERAPAMIL HYDROCHLORIDE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C08DA01

INN (Nama Internasional):

VERAPAMIL

Dosis:

180MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

VERAPAMIL HYDROCHLORIDE 180MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0113846004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-01-08

Karakteristik produk

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