MINT-ARIPIPRAZOLE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ARIPIPRAZOLE

Доступно од:

MINT PHARMACEUTICALS INC

АТЦ код:

N05AX12

INN (Међународно име):

ARIPIPRAZOLE

Дозирање:

5MG

Фармацеутски облик:

TABLET

Састав:

ARIPIPRAZOLE 5MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

ATYPICAL ANTIPSYCHOTICS

Резиме производа:

Active ingredient group (AIG) number: 0152514002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2018-12-03

Карактеристике производа

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets; 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg;
Oral
Antipsychotic agent
Manufacturer’s Standard
MINT PHARMACEUTICALS INC.
6575 Davand Drive,
Mississauga, Ontario,
L5T 2M3
Date of Initial Authorization:
December 03, 2018
Date of Revision:
October 4, 2022
Submission Control No: 264121
_MINT-ARIPIPRAZOLE _
_ _
_Product Monograph _
Page 2_ of 68 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
11/2021
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
........................................................................................................
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
.................................................................................................
7
4.5
Missed Dose
...............................