TEVA-PAROXETINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE)

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE

Dávkování:

10MG

Léková forma:

TABLET

Složení:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE) 10MG

Podání:

ORAL

Jednotky v balení:

30/100

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0123131003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2010-06-01

Charakteristika produktu

Teva-Paroxetine
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride), Oral
Teva Standard
Selective Serotonin Reuptake Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 267886
Date of Initial Authorization:
December 9, 2003
Date of Revision:
February 12, 2024
Teva-Paroxetine
_Page 2 of 63_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE ARE NOT LISTED.
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1 INDICATIONS
..........................................................................................................................
4
1.1 Pediatrics
.....................................................................................................................
4
1.2 Geriatrics
......................................................................................................................
4
2 CONTRAINDICATIONS
............................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
6
4 DOSAGE AND ADMINISTRATION
............................................................................................
6
4.1 Dosing Considerations
..................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................. 7
4.4 Administration
.............................................................................................................
9
4.5 Missed Dose
................................................................