TEVA-QUETIAPINE XR TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

QUETIAPINE (QUETIAPINE FUMARATE)

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

N05AH04

SNN (starptautisko nepatentēto nosaukumu):

QUETIAPINE

Deva:

400MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

QUETIAPINE (QUETIAPINE FUMARATE) 400MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

Active ingredient group (AIG) number: 0131858007; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-03-08

Produkta apraksts

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_Teva-Quetiapine XR Tablets_
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_Page 1 of 93_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as
quetiapine fumarate), Oral
Teva Standard
Antipsychotic / Antidepressant Agent
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
March 08, 2013
Date of Revision:
August 25, 2022
Submission Control No: 262415
_ _
_Teva-Quetiapine XR Tablets_
_ _
_Page 2 of 93_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis
08/2022
7 WARNINGS AND PRECAUTIONS - Psychiatric
08/2022
7 Warnings and Precautions - Skin
08/2022
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
...................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2.
CONTRAINDICATIONS
.................................................................................................
5
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
4.
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
...............................................................