APO-OXAZEPAM TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

OXAZEPAM

Sẵn có từ:

APOTEX INC

Mã ATC:

N05BA04

INN (Tên quốc tế):

OXAZEPAM

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

OXAZEPAM 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/1000

Loại thuốc theo toa:

Targeted (CDSA IV)

Khu trị liệu:

BENZODIAZEPINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0102420003; AHFS:

Tình trạng ủy quyền:

MARKETED

Ngày ủy quyền:

1979-12-31

Đặc tính sản phẩm

_APO-OXAZEPAM (oxazepam tablets) _
_ _
_Page 1 of 28 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
APO-OXAZEPAM
Oxazepam Tablets
Tablets, 10 mg, 15 mg and 30 mg, oral
Apotex Standard
Anxiolytic-Sedative
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUN 21, 1979
Date of Revision:
SEP 05, 2023
Submission Control Number: 273440
_APO-OXAZEPAM (oxazepam tablets) _
_ _
_Page 2 of 28 _
_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
09/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-Feeding
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
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
..................................