CHAMPIX KIT

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

VARENICLINE (VARENICLINE TARTRATE); VARENICLINE (VARENICLINE TARTRATE)

Boleh didapati daripada:

PFIZER CANADA ULC

Kod ATC:

N07BA03

INN (Nama Antarabangsa):

VARENICLINE

Dos:

0.5MG; 1MG

Borang farmaseutikal:

KIT

Komposisi:

VARENICLINE (VARENICLINE TARTRATE) 0.5MG; VARENICLINE (VARENICLINE TARTRATE) 1MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

11X0.5MG + 14X1MG

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS AUTONOMIC DRUGS

Ringkasan produk:

Active ingredient group (AIG) number: 0252269001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2007-08-21

Ciri produk

_CHAMPIX (varenicline tartrate) - Product Monograph _
_Page 1 of 60 _
_ _
PRODUCT MONOGRAPH
Pr
CHAMPIX
®
(varenicline tartrate tablets)
0.5 mg and 1.0 mg varenicline (as varenicline tartrate)
Smoking-Cessation Aid
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
® C.P. Pharmaceuticals International C.V.
Pfizer Canada Inc., licensee
© 2019 Pfizer Canada ULC
Date of Revision:
January 22, 2019
Submission Control No: 221214
_CHAMPIX (varenicline tartrate) - Product Monograph _
_Page 2 of 60 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
INDICATIONS AND CLINICAL USE
............................................................................32
STORAGE AND STABILITY
..........................................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
..........................................................