APO-ARIPIPRAZOLE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ARIPIPRAZOLE

Mevcut itibaren:

APOTEX INC

ATC kodu:

N05AX12

INN (International Adı):

ARIPIPRAZOLE

Doz:

15MG

Farmasötik formu:

TABLET

Kompozisyon:

ARIPIPRAZOLE 15MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

ATYPICAL ANTIPSYCHOTICS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-04-10

Ürün özellikleri

Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
USP
Antipsychotic agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
APR 10, 2018
Date of Revision:
JUL 24, 2023
Submission Control No: 265939
Page 2 of 66
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
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
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
...............................................................................................