ELAVIL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMITRIPTYLINE HYDROCHLORIDE

Dostopno od:

AA PHARMA INC

Koda artikla:

N06AA09

INN (mednarodno ime):

AMITRIPTYLINE

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

AMITRIPTYLINE HYDROCHLORIDE 10MG

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: 0101524001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-08-03

Lastnosti izdelka

_ELAVIL_
_®_
_ (amitriptyline hydrochloride) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ELAVIL
®
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
AA PHARMA INC.
1165 Creditstone Road Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
April 28, 1975
Date of Revision:
May 09, 2023
Submission Control Number: 268308
_ _
_ELAVIL_
_®_
_ (amitriptyline hydrochloride) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
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
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........