MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VERAPAMIL HYDROCHLORIDE

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

C08DA01

INN (Διεθνής Όνομα):

VERAPAMIL

Δοσολογία:

240MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

VERAPAMIL HYDROCHLORIDE 240MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0113846003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-01-08

Αρχείο Π.Χ.Π.

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