JAMP-AMITRIPTYLINE TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

AMITRIPTYLINE HYDROCHLORIDE

Tillgänglig från:

JAMP PHARMA CORPORATION

ATC-kod:

N06AA09

INN (International namn):

AMITRIPTYLINE

Dos:

10MG

Läkemedelsform:

TABLET

Sammansättning:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Administreringssätt:

ORAL

Enheter i paketet:

100/1000

Receptbelagda typ:

Prescription

Terapiområde:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0101524001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2016-09-14

Produktens egenskaper

_JAMP-Amitriptyline_
_ _
_(Amitriptyline Hydrochloride Tablets)_ Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JAMP-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
September 14, 2016
Date of Revision:
February 7, 2023
Submission Control Number: 267331
_JAMP-Amitriptyline_
_ _
_(Amitriptyline Hydrochloride Tablets)_ Page 2 of 34
RECENT MAJOR LABEL CHANGES
7 Warnings and precautions, Neurologic
02/2023
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
....................................................... 6
4.4 Administration
.............................