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 TAB

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-06-13

Αρχείο Π.Χ.Π.

_Mylan-Verapamil SR Product Monograph _
_Page 1 of 42 _
PRODUCT MONOGRAPH
PR
MYLAN-VERAPAMIL SR
verapamil hydrochloride sustained-release tablets
120 mg, 180 mg and 240 mg
Antihypertensive Agent
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
July 15, 2009
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
June 3, 2015
Submission Control No: 184288
_Mylan-Verapamil SR Product Monograph _
_Page 2 of 42 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
..........................................................................31
DETAILED PHARMACOLOGY
..................................................................