SERTRALINE CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

제공처:

SANIS HEALTH INC

ATC 코드:

N06AB06

INN (국제 이름):

SERTRALINE

복용량:

25MG

약제 형태:

CAPSULE

구성:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2010-06-08

제품 특성 요약

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