ABILIFY TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ARIPIPRAZOLE

Prieinama:

OTSUKA PHARMACEUTICAL CO LTD

ATC kodas:

N05AX12

INN (Tarptautinis Pavadinimas):

ARIPIPRAZOLE

Dozė:

15MG

Vaisto forma:

TABLET

Sudėtis:

ARIPIPRAZOLE 15MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100

Recepto tipas:

Prescription

Gydymo sritis:

ATYPICAL ANTIPSYCHOTICS

Produkto santrauka:

Active ingredient group (AIG) number: 0152514003; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2017-12-01

Prekės savybės

_ABILIFY_
_®_
_ Product Monograph _
_Page 1 of 77_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ABILIFY
®
Aripiprazole Tablets
2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
Manufacturer’s Standard
Antipsychotic agent
Otsuka Pharmaceutical Co., Ltd.
Tokyo, 101-8535 Japan
Imported and Marketed by:
Otsuka Canada Pharmaceutical Inc.
Saint-Laurent, QC
H4S 2C9
Date of Initial Approval:
July 3, 2009
Date of Revision:
February 11, 2021
Submission Control No: 242200
_ _
_ABILIFY_
_®_
_ Product Monograph _
_Page 2 of 77_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
02/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
...........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 7
4.3
Administration
........................................................................................................
9
4.4
Reconst