APO-SERTRALINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Tersedia dari:

APOTEX INC

Kode ATC:

N06AB06

INN (Nama Internasional):

SERTRALINE

Dosis:

50MG

Bentuk farmasi:

CAPSULE

Komposisi:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

100/250

Jenis Resep:

Prescription

Area terapi:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0123417001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1999-09-01

Karakteristik produk

_APO-SERTRALINE (Sertraline hydrochloride Capsules)_
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SERTRALINE
Sertraline Hydrochloride Capsules
Capsules, 25 mg, 50 mg and 100 mg sertraline (as sertraline
hydrochloride), Oral
Apotex Standard
Antidepressant / Antipanic / Antiobsessional Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 01, 1999
Date of Revision
JUN 23, 2023
Submission Control Number: 274621
_APO-SERTRALINE (Sertraline hydrochloride Capsules)_
_Page 2 of 70 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
06/2023
7.1.1 Pregnant Women
06/2023
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
.............................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
6
4
DOSAGE AND ADMINISTRATION
..........................................................................................
6
4.1
Dosing Considerations
........................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..............................................................