البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
MIRTAZAPINE
PRO DOC LIMITEE
N06AX11
MIRTAZAPINE
30MG
TABLET
MIRTAZAPINE 30MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928002; AHFS:
APPROVED
2008-07-02
PRO-MIRTAZAPINE Page 1 of 43 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PRO-MIRTAZAPINE Mirtazapine Tablets 15 mg, 30 mg and 45 mg House Standard ANTI-DEPRESSANT Pro Doc Ltée. 2925, boul. Industriel Laval, Quebec H7L 3W9 Submission Control No.: 279376 Date of Initial Approval: July 02,2008 Date of Revision: October 20, 2023 PRO-MIRTAZAPINE Page 2 of 43 RECENT MAJOR LABEL CHANGES 7. WARNINGS AND PRECAUTIONS, Skin 08/2021 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 ........... اقرأ الوثيقة كاملة