TEVA-OLANZAPINE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

OLANZAPINE

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

N05AH03

INN (nemzetközi neve):

OLANZAPINE

Adagolás:

10MG

Gyógyszerészeti forma:

TABLET

Összetétel:

OLANZAPINE 10MG

Az alkalmazás módja:

ORAL

db csomag:

100/500

Recept típusa:

Prescription

Terápiás terület:

ATYPICAL ANTIPSYCHOTICS

Termék összefoglaló:

Active ingredient group (AIG) number: 0128783002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2007-06-06

Termékjellemzők

_Teva-Olanzapine _
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_Page 1 of 69 _
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 _
_ _
_Page 2 of 69 _
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