APO-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

可用日期:

APOTEX INC

ATC代码:

N06AX16

INN（国际名称）:

VENLAFAXINE

剂量:

75MG

药物剂型:

CAPSULE (EXTENDED RELEASE)

组成:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

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: 0131294001; AHFS:

授权状态:

APPROVED

授权日期:

2012-05-02

产品特点

_APO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release
Capsules) Page 1 of 87 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-VENLAFAXINE XR
Venlafaxine Hydrochloride Extended-Release Capsules
Extended-Release Capsules, 37.5 mg, 75 mg and 150 mg venlafaxine (as
venlafaxine
hydrochloride), oral
Manufacturer's Standard
Antidepressant / Anxiolytic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 10, 2019
Date of Revision:
MAR 10, 2023
Submission Control Number: 272419
_APO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release
Capsules) Page 2 of 87 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2023
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
...........................................