ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

OLANZAPINE

Inapatikana kutoka:

ABBOTT LABORATORIES, LIMITED

ATC kanuni:

N05AH03

INN (Jina la Kimataifa):

OLANZAPINE

Kipimo:

10MG

Dawa fomu:

TABLET (ORALLY DISINTEGRATING)

Tungo:

OLANZAPINE 10MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

ATYPICAL ANTIPSYCHOTICS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2015-12-31

Tabia za bidhaa

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