DOM-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OLANZAPINE

Dostupné z:

DOMINION PHARMACAL

ATC kód:

N05AH03

INN (Medzinárodný Name):

OLANZAPINE

Dávkovanie:

10MG

Forma lieku:

TABLET (ORALLY DISINTEGRATING)

Zloženie:

OLANZAPINE 10MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2010-08-05

Súhrn charakteristických

PRODUCT MONOGRAPH
Pr
DOM-OLANZAPINE
Olanzapine Tablets, USP
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
Pr
DOM-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg & 15 mg
Antipsychotic Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision
February 14, 2014
Submission Control No: 171570
_ _
_Dom-OLANZAPINE & Dom-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
..................................................................................................14
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
......................................................................