CLOZAPINE TABLETS

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CLOZAPINE

Tersedia dari:

INNOMAR STRATEGIES INC.

Kode ATC:

N05AH02

INN (Nama Internasional):

CLOZAPINE

Dosis:

100MG

Bentuk farmasi:

TABLET

Komposisi:

CLOZAPINE 100MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

Active ingredient group (AIG) number: 0122583002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-10-11

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Clozapine Tablets
25 mg and 100 mg
House Standard
Antipsychotic Agent
Innomar Strategies Inc. DATE OF REVISION:
3470 Superior Court October 11, 2018
Oakville, Ontario
L6L 0C4
Control No.: 219938
_Product Monograph _
_August 2018 _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...............................................................................................
21
DRUG INTERACTIONS
................................................................................................
28
DOSAGE AND ADMINISTRATION
...............................................................................
29
OVERDOSAGE
............................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 35
STORAGE AND STABILITY
.........................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 36
PART II: SCIENTIFIC INFORMATION
....................................................................................
38
PHARMACEUTICAL INFORMATION
...........................................................................
38
CLINICAL TRIALS
........................................................................................................
39
DETAILED PHARMACOLOGY
...........................