PMS-OLANZAPINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

OLANZAPINE

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

N05AH03

SNN (starptautisko nepatentēto nosaukumu):

OLANZAPINE

Deva:

7.5MG

Zāļu forma:

TABLET

Kompozīcija:

OLANZAPINE 7.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

Active ingredient group (AIG) number: 0128783004; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2008-04-02

Produkta apraksts

_pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph _
_Page 1 of 67_
PRODUCT MONOGRAPH
Pr
PMS-OLANZAPINE
Olanzapine Tablets, USP
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg & 20 mg
Pr
PMS-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg and 20 mg
Antipsychotic Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Revision: July 16, 2018
Submission Control No: 217394
_pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph _
_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................30
DOSAGE AND ADMINISTRATION
..............................................................................32
OVERDOSAGE
................................................................................................................34
ACTION AND CLINICAL PHARMACOLOGY
............................................................35
STORAGE AND STABILITY
..........................................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................38
PART II: SCIENTIFIC INFORMATION
................................................................................40
PHARMACEUTICAL INFORMATION
...........................................................