MINT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

OLANZAPINE

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

N05AH05

INN (שם בינלאומי):

ASENAPINE

כמות:

5MG

טופס פרצבטיות:

TABLET (ORALLY DISINTEGRATING)

הרכב:

OLANZAPINE 5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

Active ingredient group (AIG) number: 0128783003; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2015-02-04

מאפייני מוצר

Page 1 of 60
PRODUCT MONOGRAPH
PR
MINT-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg, 20
m
g
USP
Antipsychotic
Agent
Mint Pharmaceuticals Inc.
Date of Revision:
6575 Davand Drive
February 8, 2021
Mississauga, Ontario
L5T 2M3
SUBMISSION CONTROL NO: 244805
Page 2 of 60
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
...........................................................................................................4
WARNINGS AND PRECAUTIONS
..........................................................................................4
ADVERSE REACTIONS
..........................................................................................................14
DRUG INTERACTIONS
..........................................................................................................30
DOSAGE AND ADMINISTRATION
......................................................................................32
OVERDOSAGE
........................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
....................................................................34
STORAGE AND STABILITY
..................................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................37
PART II: SCIENTIFIC INFORMATION
...............................................................................38
PHARMACEUTICAL INFORMATION
..................................................................................38
CLINICAL TRIALS
.............................................................................................