SERTRALINE CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

متاح من:

SANIS HEALTH INC

ATC رمز:

N06AB06

INN (الاسم الدولي):

SERTRALINE

جرعة:

25MG

الشكل الصيدلاني:

CAPSULE

تركيب:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2010-06-08

خصائص المنتج

_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
.........................................................................