AURO-CLOZAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CLOZAPINE

Tersedia dari:

AURO PHARMA INC

Kode ATC:

N05AH02

INN (Nama Internasional):

CLOZAPINE

Dosis:

25MG

Bentuk farmasi:

TABLET

Komposisi:

CLOZAPINE 25MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-05-26

Karakteristik produk

_AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 1 of 52
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CLOZAPINE
Clozapine Tablets, USP
25 mg, 50 mg, 100 mg and 200 mg
Antipsychotic Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
CANADA.
Date of Initial Authorization:
April 06, 2016
Date of Revision:
September 28, 2022
Submission Control No.: 266744
_AURO-CLOZAPINE PRODUCT MONOGRAPH _Page 2 of 52
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2022
7 WARNINGS AND PRECAUTIONS, General, Anticholinergic Activity
03/2022
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
........................................................................
4
1
INDICATIONS..........................................................................................................................
4
1.1 Pediatrics
.................................................................................................................
5
1.2
Geriatrics..................................................................................................................
5
2 CONTRAINDICATIONS
............................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX........................................................................
6
4 DOSAGE AND ADMINISTRATION
............................................................................................
7
4.1 Dosing Considerations
..............................................................................................
7
4.2 Recommended Dose and Dos