ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

OLANZAPINE

Dostępny od:

ABBOTT LABORATORIES, LIMITED

Kod ATC:

N05AH03

INN (International Nazwa):

OLANZAPINE

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET (ORALLY DISINTEGRATING)

Skład:

OLANZAPINE 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2015-12-31

Charakterystyka produktu

_ _
_Abbott-Olanzapine ODT Product Monograph _
_Page 1 of 62 _
PRODUCT MONOGRAPH
PR
ABBOTT-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg, 20 mg
Antipsychotic Agent
BGP Pharma Inc.
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
January 6, 2015
Submission Control No.: 180719
_ _
_Abbott-Olanzapine ODT Product Monograph _
_Page 2 of 62 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
............................................................................................