TEVA-OLANZAPINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
10-09-2020
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Aktiv ingrediens:
OLANZAPINE
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
N05AH03
INN (International Name):
OLANZAPINE
Dosering :
7.5MG
Legemiddelform:
TABLET
Sammensetning:
OLANZAPINE 7.5MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
ATYPICAL ANTIPSYCHOTICS
Produkt oppsummering:
Active ingredient group (AIG) number: 0128783004; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2007-06-06
Preparatomtale
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PRODUCT MONOGRAPH
PR
TEVA-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg
USP
Antipsychotic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 239722
Date of Revision:
September 10, 2020
_Teva-Olanzapine _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
..................................................................................................
15
DRUG
INTERACTIONS...................................................................................................
30
DOSAGE AND ADMINISTRATION
..............................................................................
32
OVERDOSAGE
.................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
..........................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 37
PART II: SCIENTIFIC INFORMATION
.................................................................................
39
PHARMACEUTICAL INFORMATION
..........................................................................
39
CLINICAL TRIALS
..........................................................................................................
40
DET
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