PHL-OLANZAPINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OLANZAPINE

Dostupné z:

PHARMEL INC

ATC kód:

N05AH03

INN (Medzinárodný Name):

OLANZAPINE

Dávkovanie:

5MG

Forma lieku:

TABLET

Zloženie:

OLANZAPINE 5MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Prehľad produktov:

Active ingredient group (AIG) number: 0128783003; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2016-10-25

Súhrn charakteristických

PRODUCT MONOGRAPH
Pr
PHL-OLANZAPINE
Olanzapine Tablets, USP
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
Pr
PHL-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg & 15 mg
Antipsychotic Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision
February 14, 2014
Submission Control No: 171568
_ _
_phl-OLANZAPINE & phl-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
............................................................................