APO-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

QUETIAPINE (QUETIAPINE FUMARATE)

Доступно од:

APOTEX INC

АТЦ код:

N05AH04

INN (Међународно име):

QUETIAPINE

Дозирање:

300MG

Фармацеутски облик:

TABLET (IMMEDIATE RELEASE)

Састав:

QUETIAPINE (QUETIAPINE FUMARATE) 300MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

ATYPICAL ANTIPSYCHOTICS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2020-07-31

Карактеристике производа

_APO-QUETIAPINE FUMARATE (Quetiapine tablets)_
_Page 1 of 71_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-QUETIAPINE FUMARATE
Quetiapine tablets
Immediate-Release Tablets, 25 mg, 100 mg, 200 mg and 300 mg quetiapine
(as quetiapine
fumarate), Oral
USP
Antipsychotic Agent
Apotex Inc.
150 Signet Drive
Toronto, Ontario M9L 1T9
Canada
Date of Initial Authorization:
July 31, 2020 Date of Revision:
December 6, 2022
Submission Control No: 265729
_APO-QUETIAPINE FUMARATE (Quetiapine tablets)_
_Page 2 of 71_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Musculoskeletal -
Rhabdomyolysis
12/2022
7 WARNINGS AND PRECAUTIONS - Psychiatric
12/2022
1 INDICATIONS, 1.1 Pediatrics
12/2022
2 CONTRAINDICATIONS
12/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment, Dosing Considerations in Special
Populations, Pediatric Use
12/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
12/2022
7 WARNINGS AND PRECAUTIONS, Weight Gain
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
7 WARNINGS AND PRECAUTIONS, 7.3 Pediatrics
12/2022
7 WARNINGS AND PRECAUTIONS, Use in Geriatric Patients with
Dementia
12/2022
7 WARNINGS AND PRECAUTIONS, Skin
12/2022
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
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics....................................................................................................................
4
2
CONTRAINDICATIONS
....