PMS-ARIPIPRAZOLE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ARIPIPRAZOLE

Dostupné z:

PHARMASCIENCE INC

ATC kód:

N05AX12

INN (Medzinárodný Name):

ARIPIPRAZOLE

Dávkovanie:

15MG

Forma lieku:

TABLET

Zloženie:

ARIPIPRAZOLE 15MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2018-07-10

Súhrn charakteristických

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..........................