JAMP-AMITRIPTYLINE TABLETS

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

AMITRIPTYLINE HYDROCHLORIDE

Prieinama:

JAMP PHARMA CORPORATION

ATC kodas:

N06AA09

INN (Tarptautinis Pavadinimas):

AMITRIPTYLINE

Dozė:

25MG

Vaisto forma:

TABLET

Sudėtis:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/1000

Recepto tipas:

Prescription

Gydymo sritis:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

MARKETED

Leidimo data:

2015-01-12

Prekės savybės

_JAMP-Amitriptyline Tablets (Amitriptyline _
_Hydrochloride Tablets)_
_ _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-AMITRIPTYLINE TABLETS
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 272470
Date of Initial Authorization:
December 12, 2014
Date of Revision:
March 10, 2023
_JAMP-Amitriptyline Tablets (Amitriptyline Hydrochloride Tablets)_
_ _
_ _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
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
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................................
5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................