PMS-ARIPIPRAZOLE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ARIPIPRAZOLE

Beschikbaar vanaf:

PHARMASCIENCE INC

ATC-code:

N05AX12

INN (Algemene Internationale Benaming):

ARIPIPRAZOLE

Dosering:

15MG

farmaceutische vorm:

TABLET

Samenstelling:

ARIPIPRAZOLE 15MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

ATYPICAL ANTIPSYCHOTICS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2018-07-10

Productkenmerken

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
House Standard
Antipsychotic Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF INITIAL AUTHORIZATION
JUL 10, 2018
DATE OF REVISION:
OCT 17, 2022
Submission Control No: 264122
_pms-ARIPIPRAZOLE Product Monograph _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
11/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatric
.................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
........................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.3
Administration
........................................................................................................
7
4.4
Reconstitution..........................