GD-MIRTAZAPINE OD TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MIRTAZAPINE

Boleh didapati daripada:

GENMED A DIVISION OF PFIZER CANADA ULC

Kod ATC:

N06AX11

INN (Nama Antarabangsa):

MIRTAZAPINE

Dos:

30MG

Borang farmaseutikal:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

MIRTAZAPINE 30MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

5X6

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTIDEPRESSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0143928002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2014-12-08

Ciri produk

_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
GD-MIRTAZAPINE OD*
(Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg and 45 mg)
Antidepressant
GenMed, a division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
*GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
© Pfizer Canada Inc., 2012
Submission control No.: 153710 Date of Revision:
March 29, 2012
_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE
REACTIONS..........................................................................................................
9
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 20
STORAGE AND
STABILITY................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................