ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OLANZAPINE

Fáanlegur frá:

ABBOTT LABORATORIES, LIMITED

ATC númer:

N05AH03

INN (Alþjóðlegt nafn):

OLANZAPINE

Skammtar:

10MG

Lyfjaform:

TABLET (ORALLY DISINTEGRATING)

Samsetning:

OLANZAPINE 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ATYPICAL ANTIPSYCHOTICS

Vörulýsing:

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

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2015-12-31

Vara einkenni

_ _
_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
............................................................................................