Q-PAROXETINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PAROXETINE (PAROXETINE HYDROCHLORIDE, ISOPROPYL SOLVATE)

Tilgjengelig fra:

QD PHARMACEUTICALS ULC

ATC-kode:

N06AB05

INN (International Name):

PAROXETINE

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

PAROXETINE (PAROXETINE HYDROCHLORIDE, ISOPROPYL SOLVATE) 10MG

Administreringsrute:

ORAL

Enheter i pakken:

10/20/30/100/500

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2015-08-21

Preparatomtale

_1_
PRODUCT MONOGRAPH
PR
Q-PAROXETINE
Paroxetine Tablets, USP
10 mg, 20 mg and 30 mg
Paroxetine (as paroxetine hydrochloride isopropyl solvate)
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
–
Social Phobia (Social Anxiety Disorder) - Posttraumatic Stress
Disorder Therapy
QD Pharmaceuticals ULC Date of Revision:
85 Advance Road
May 04, 2015
Etobicoke, Ontario
M8Z 2S6
Submission Control No: 183548
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_2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3
SUMMARY
PRODUCT
INFORMATION
..............................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
AND
PRECAUTIONS
........................................................................................
6
ADVERSE
REACTIONS
.........................................................................................................
14
DRUG
INTERACTIONS
.........................................................................................................
24
DOSAGE
AND
ADMINISTRATION
....................................................................................
29
OVERDOSAGE
..........................................................................................................................
32
ACTION
AND
CLINICAL
PHARMACOLOGY
.................................................................. 33
STORAGE
AND
STABILITY
.................................................................................................
35
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
.................................................. 35
PART II: SCIENTIFIC INFORMATION ..............................................................................
37
PHARMACEUTICAL
INFORMATION
..........................................................