MINT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

OLANZAPINE

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

N05AH05

INN (Nama Internasional):

ASENAPINE

Dosis:

5MG

Bentuk farmasi:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

OLANZAPINE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-02-04

Karakteristik produk

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