JAMP-AMITRIPTYLINE TABLETS

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMITRIPTYLINE HYDROCHLORIDE

Dostopno od:

JAMP PHARMA CORPORATION

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:

2015-01-12

Lastnosti izdelka

_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
................