NORTRIPTYLINE CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Pieejams no:

APOTEX INC

ATĶ kods:

N06AA10

SNN (starptautisko nepatentēto nosaukumu):

NORTRIPTYLINE

Deva:

25MG

Zāļu forma:

CAPSULE

Kompozīcija:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 25MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0102630001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-04-06

Produkta apraksts

_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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_ _
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_ Page 2 of 33_
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RECENT MAJOR LABEL CHANGES
N/A
N/A
TABLE OF CONTENTS
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SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED._ _
RECENT MAJOR LABEL CHANGES
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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
..............................