PHL-FLUOXETINE - SOLUTION 20MG/5ML

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Tilgjengelig fra:

PHARMEL INC

ATC-kode:

N06AB03

INN (International Name):

FLUOXETINE

Dosering :

20MG

Legemiddelform:

SOLUTION

Sammensetning:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG

Administreringsrute:

ORAL

Enheter i pakken:

120 ML

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0116847002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2017-02-08

Preparatomtale

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Page 1 of 46
PRODUCT MONOGRAPH
Pr
phl-FLUOXETINE
®
(fluoxetine hydrochloride) Capsules
10 mg and 20 mg
Pr
phl-FLUOXETINE
®
(fluoxetine hydrochloride) Oral Solution
20 mg/5 mL
Antidepressant / Antiobsessional / Antibulimic
PHARMEL INC.
8699, 8th Ave
Montreal, Quebec
H1Z 2X4
Control #: 103904
DATE OF PREPARATION:
January 13, 2003
DATE OF REVISION:
April 28, 2006
_ _
Page 2 of 46
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL
USE...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
5
ADVERSE
REACTIONS.......................................................................................................
11
DRUG INTERACTIONS
.......................................................................................................
19
DOSAGE AND
ADMINISTRATION...................................................................................
24
OVERDOSAGE
.....................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 28
STORAGE AND
STABILITY...............................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL
INFORMATION...............................................................................
31
CLINICAL
TRIALS.....................................