Maa: Kanada
Kieli: englanti
Lähde: Health Canada
MIRTAZAPINE
NU-PHARM INC
N06AX11
MIRTAZAPINE
30MG
TABLET
MIRTAZAPINE 30MG
ORAL
100
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928002; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
Page 1 of 32 PRODUCT MONOGRAPH PR NU-MIRTAZAPINE Mirtazapine Tablets USP 15 mg, 30 mg and 45 mg Antidepressant NU-PHARM INC. DATE OF PREPARATION: 50 Mural St., Units 1 & 2 October 14, 2009 Richmond Hill, Ontario L4B 1E4 Control#: 133373 Page 2 of 32 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......................................................................................................... 7 DRUG INTERACTIONS ....................................................................................................... 12 DOSAGE AND ADMINISTRATION ................................................................................... 12 OVERDOSAGE...................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY.................................................................. 14 STORAGE AND STABILITY............................................................................................... 17 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 17 PART II: SCIENTIFIC INFORMATION ............................................................................. 19 PHARMACEUTICAL INFORMATION............................................................................... 19 CLINICAL TRIALS ............................................................................................................... 20 DETAILED PHARMACOLOGY ................................... Lue koko asiakirja