SERTRALINE CAPSULE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Beszerezhető a:

SANIS HEALTH INC

ATC-kód:

N06AB06

INN (nemzetközi neve):

SERTRALINE

Adagolás:

25MG

Gyógyszerészeti forma:

CAPSULE

Összetétel:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0123417003; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2010-06-08

Termékjellemzők

_Page 1 of 62_
_SERTRALINE Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SERTRALINE
Sertraline Hydrochloride Capsules
Capsules, 25 mg, 50 mg and 100 mg sertraline (as sertraline
hydrochloride), Oral
Antidepressant / Antipanic / Antiobsessional Agent
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 274293
Date of Initial Authorization:
JUL 27, 2010
Date of Revision:
MAY 03, 2023
_SERTRALINE Product Monograph _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2022
7.1.1 Pregnant Women
07/2022
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
.......................................................................................................................
5
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
............................................................. 6
4.4
Administration
.........................................................................