PMS-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

제공처:

PHARMASCIENCE INC

ATC 코드:

N06AX16

INN (International Name):

VENLAFAXINE

복용량:

37.5MG

약제 형태:

CAPSULE (EXTENDED RELEASE)

구성:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0131294002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2007-08-17

제품 특성 요약

_pms-VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 1 of 84 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-VENLAFAXINE XR
Venlafaxine Hydrochloride Extended Release Capsules
Extended Release Capsules, 37.5 mg, 75 mg and 150 mg venlafaxine (as
venlafaxine hydrochloride), Oral
Antidepressant / Anxiolytic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 270919
Date of Initial Authorization:
AUG 17, 2007
Date of Revision:
JAN 25, 2023
_pms-VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 2 of 84 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
01/2023
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
06/2020
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
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Adults
.