PMS-ARIPIPRAZOLE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-10-2022
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Aktiv ingrediens:
ARIPIPRAZOLE
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
N05AX12
INN (International Name):
ARIPIPRAZOLE
Dosering :
5MG
Legemiddelform:
TABLET
Sammensetning:
ARIPIPRAZOLE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
30
Resept typen:
Prescription
Terapeutisk område:
ATYPICAL ANTIPSYCHOTICS
Produkt oppsummering:
Active ingredient group (AIG) number: 0152514002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-07-10
Preparatomtale
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..........................
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