APO-MIRTAZAPINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MIRTAZAPINE

Sẵn có từ:

APOTEX INC

Mã ATC:

N06AX11

INN (Tên quốc tế):

MIRTAZAPINE

Liều dùng:

45MG

Dạng dược phẩm:

TABLET

Thành phần:

MIRTAZAPINE 45MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTIDEPRESSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0143928003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2006-10-03

Đặc tính sản phẩm

_APO-MIRTAZAPINE (Mirtazapine Tablets) _
_ _
_Page 1 of 44 _
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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
.....................................................