Maa: Kanada
Kieli: englanti
Lähde: Health Canada
MIRTAZAPINE
GENMED A DIVISION OF PFIZER CANADA ULC
N06AX11
MIRTAZAPINE
30MG
TABLET (ORALLY DISINTEGRATING)
MIRTAZAPINE 30MG
ORAL
5X6
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928002; AHFS:
CANCELLED POST MARKET
2014-12-08
_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 ................................................. Lue koko asiakirja