NORTRIPTYLINE CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
05-04-2023

有效成分:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

可用日期:

APOTEX INC

ATC代码:

N06AA10

INN(国际名称):

NORTRIPTYLINE

剂量:

10MG

药物剂型:

CAPSULE

组成:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0102630002; AHFS:

授权状态:

APPROVED

授权日期:

2021-04-06

产品特点

                                _NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
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_ Page 1 of 33_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NORTRIPTYLINE
Nortriptyline Hydrochloride Capsules
Capsules, 10 mg and 25 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
APR 01, 2021
Date of Revision:
APRIL 5, 2023
Submission Control Number: 269184
_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
_ _
_ _
_ _
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_ Page 2 of 33_
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RECENT MAJOR LABEL CHANGES
N/A
N/A
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
INDICATION
.................................................................................................................
4
1.1
PEDIATRICS
................................................................................................................
4
1.2
GERIATRICS
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
.....................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING CONSIDERATIONS
............................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.4
ADMINISTRATION
..............................
                                
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