CLOZAPINE TABLETS

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CLOZAPINE

MAH:

INNOMAR STRATEGIES INC.

ATC_code:

N05AH02

INN:

CLOZAPINE

dosage:

100MG

pharmaceutical_form:

TABLET

composition:

CLOZAPINE 100MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2018-10-11

SPC

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
...........................