ABILIFY MAINTENA POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ARIPIPRAZOLE

Verfügbar ab:

OTSUKA PHARMACEUTICAL CO LTD

ATC-Code:

N05AX12

INN (Internationale Bezeichnung):

ARIPIPRAZOLE

Dosierung:

300MG

Darreichungsform:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Zusammensetzung:

ARIPIPRAZOLE 300MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

ATYPICAL ANTIPSYCHOTICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0152514007; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2015-08-20

Fachinformation

_ABILIFY MAINTENA_
_® _
_Product Monograph _
_ _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ABILIFY MAINTENA
®
Aripiprazole for prolonged release injectable suspension
300 mg and 400 mg vial
300 mg and 400 mg dual chamber syringe
Antipsychotic agent
Otsuka Pharmaceutical Co., Ltd.
Tokyo, 101-8535 Japan
Imported by:
Otsuka Canada Pharmaceutical Inc.
Saint-Laurent, QC
H4S 2C9
Marketed by:
Otsuka Canada Pharmaceutical Inc.
Saint-Laurent, QC
H4S 2C9
Date of Initial Approval:
February 10, 2014
Date of Revision:
March 2, 2021
Lundbeck Canada Inc.
Saint-Laurent, QC
H4S 0A9
Submission Control No: 237149
_ _
_ABILIFY MAINTENA_
_®_
_ Product Monograph _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
Warnings and precautions, Immune, Drug Reaction with Eosinophilia and
Systemic Symptoms
(DRESS) DEC 2020
Warnings and precautions, Skin FEB 2021
Dosage and administration, Dosing Considerations, Recommended Dose and
Dosage
Adjustment, Administration, Reconstitution, Missed Dose FEB 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
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
....................