ACT VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
08-09-2023

有效成分:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

可用日期:

TEVA CANADA LIMITED

ATC代码:

N06AX16

INN(国际名称):

VENLAFAXINE

剂量:

150MG

药物剂型:

CAPSULE (EXTENDED RELEASE)

组成:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0131294005; AHFS:

授权状态:

APPROVED

授权日期:

2019-03-01

产品特点

                                ACT VENLAFAXINE XR
Page 1 of 87
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACT 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
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
http://www.tevacanada.com
Submission Control Number: 274510
Date of Initial Authorization:
August 14, 2014
Date of Revision:
September 08, 2023
ACT VENLAFAXINE XR
Page 2 of 87
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
09/2023
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
09/2023
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
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
......................................................... 6
4.4
Administration
..............
                                
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