RIVA-QUETIAPINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostopno od:

LABORATOIRE RIVA INC.

Koda artikla:

N05AH04

INN (mednarodno ime):

QUETIAPINE

Odmerek:

300MG

Farmacevtska oblika:

TABLET

Sestava:

QUETIAPINE (QUETIAPINE FUMARATE) 300MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

ATYPICAL ANTIPSYCHOTICS

Povzetek izdelek:

Active ingredient group (AIG) number: 0131858005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2008-09-23

Lastnosti izdelka

RIVA-QUETIAPINE - Product Monograph
Page 1 of 61
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RIVA-QUETIAPINE
Quetiapine Tablets
Tablets, 25 mg, 100 mg, 200 mg and 300 mg quetiapine (as quetiapine
fumarate), Oral
House Standard
Antipsychotic Agent
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
SEP 23, 2008
Date of Revision:
MAR 2, 2022
Submission Control Number: 261378
RIVA-QUETIAPINE - Product Monograph
Page 2 of 61
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal, Rhabdomyolysis
03/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
03/2022
7 WARNINGS AND PRECAUTIONS, Skin
03/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
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
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4
2
CONTRAINDICATIONS
.......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1.
Dosing Considerations
..............................................................................................
5
4.2.
Recommended Dos