AMITRIPTYLINE-25 TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMITRIPTYLINE HYDROCHLORIDE

Dostopno od:

PRO DOC LIMITEE

Koda artikla:

N06AA09

INN (mednarodno ime):

AMITRIPTYLINE

Odmerek:

25MG

Farmacevtska oblika:

TABLET

Sestava:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Pot uporabe:

ORAL

Enote v paketu:

100/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0101524002; AHFS:

Status dovoljenje:

MARKETED

Datum dovoljenje:

1976-12-31

Lastnosti izdelka

_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMITRIPTYLINE - 10
PR AMITRIPTYLINE - 25
PR AMITRIPTYLINE - 50
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg and 50 mg, Oral
USP
Antidepressant
PRO DOC LTÉE.
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 283162
Date of Initial Authorization:
AUG
09,
2012
Date of Revision:
FEB
16, 2024
_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
02/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
04/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
................................................................................................
5
4.1
D