MINT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

OLANZAPINE

Pieejams no:

MINT PHARMACEUTICALS INC

ATĶ kods:

N05AH05

SNN (starptautisko nepatentēto nosaukumu):

ASENAPINE

Deva:

5MG

Zāļu forma:

TABLET (ORALLY DISINTEGRATING)

Kompozīcija:

OLANZAPINE 5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-02-04

Produkta apraksts

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