GEN-CLOZAPINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CLOZAPINE

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

N05AH02

INN (Tên quốc tế):

CLOZAPINE

Liều dùng:

25MG

Dạng dược phẩm:

TABLET

Thành phần:

CLOZAPINE 25MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ATYPICAL ANTIPSYCHOTICS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0122583001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2009-08-07

Đặc tính sản phẩm

_Page 1 of 47_
_Mylan Pharmaceuticals ULC _
_June 7, 2022 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
GEN-CLOZAPINE
Clozapine Tablets
Tablets, 25 mg, 50 mg, 100 mg, 200 mg, Oral
Mylan Std.
Antipsychotic Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario M8Z 2S6
Date of Initial Authorization:
February 17, 2014
Date of Revision:
July 18, 2022
Submission Control No: 261515
_GEN-CLOZAPINE (clozapine) Product Monograph _
_June 7, 2022 _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
07/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
07/2022
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...............................................................
11
1
INDICATIONS..............................................................................................................
11
1.1
Pediatrics..........................................................................................................
12
1.2
Geriatrics
..........................................................................................................
12
2
CONTRAINDICATIONS
...............................................................................................
12
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 13
4
DOSAGE AND ADMINISTRATION
..............................................................................
13
4.1
Dosing Considerations
......................................................................................
13
4.2
Recommended Dose and Dosage
Adjustment................................................... 15
4.4
Administration
............................................