Država: Kanada
Jezik: angleščina
Source: Health Canada
MIRTAZAPINE
APOTEX INC
N06AX11
MIRTAZAPINE
45MG
TABLET
MIRTAZAPINE 45MG
ORAL
30
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928003; AHFS:
APPROVED
2006-10-03
_APO-MIRTAZAPINE (Mirtazapine Tablets) _ _ _ _Page 1 of 44 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-MIRTAZAPINE Mirtazapine Tablets 15 mg, 30 mg and 45 mg USP Antidepressant Apotex Inc. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: October 03, 2006 Date of Revision: January 31, 2022 Submission Control Number: 257508 _APO-MIRTAZAPINE (Mirtazapine Tablets) _ _ _ _Page 2 of 44 _ _ _ RECENT MAJOR LABEL CHANGES Warnings and Precautions, Skin (7) 01/2022 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................... 4 1 INDICATIONS .................................................................................................................. 4 1.1 PEDIATRICS ................................................................................................................... 4 1.2 GERIATRICS ................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 DOSING CONSIDERATIONS ........................................................................................... 5 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT ................................................... 5 4.3 ADMINISTRATION ......................................................................................................... 6 4.4 RECONSTITUTION ......................................................................................................... 6 4.5 MISSED DOSE ................................................................................................................ 6 5 OVERDOSAGE ..................................................... Preberite celoten dokument