MINT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
08-02-2021
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Aktiv ingrediens:
OLANZAPINE
Tilgjengelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N05AH05
INN (International Name):
ASENAPINE
Dosering :
5MG
Legemiddelform:
TABLET (ORALLY DISINTEGRATING)
Sammensetning:
OLANZAPINE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
30
Resept typen:
Prescription
Terapeutisk område:
ATYPICAL ANTIPSYCHOTICS
Produkt oppsummering:
Active ingredient group (AIG) number: 0128783003; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2015-02-04
Preparatomtale
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
.............................................................................................
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