QUETIAPINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

SIVEM PHARMACEUTICALS ULC

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

200MG

Forma farmaceutyczna:

TABLET

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

Droga podania:

ORAL

Sztuk w opakowaniu:

90/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131858003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-07-02

Charakterystyka produktu

_QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) _
_Page 1 of 66 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
QUETIAPINE
Quetiapine Tablets
Immediate-Release Tablets, 25 mg, 100 mg, 200 mg & 300 mg quetiapine
(as quetiapine
fumarate), Oral
Antipsychotic Agent
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control No: 263919
Date of Initial Authorization:
June 02, 2016
Date of
Revision:
June 1, 2022
_QUETIAPINE (Quetiapine Fumarate Immediate-Release Tablets) _
_Page 2 of 66 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis
06/2022
7 WARNINGS AND PRECAUTIONS - Psychiatric
06/2022
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06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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
.................................................................. 5
4.4 Administration
.......................................