PHL-FLUOXETINE - CAP 20MG CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Pieejams no:

PHARMEL INC

ATĶ kods:

N06AB03

SNN (starptautisko nepatentēto nosaukumu):

FLUOXETINE

Deva:

20MG

Zāļu forma:

CAPSULE

Kompozīcija:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0116847001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2017-02-08

Produkta apraksts

PRODUCT MONOGRAPH
PR
PHL-FLUOXETINE
Fluoxetine Capsules, USP
10 mg and 20 mg
ANTIDEPRESSANT / ANTIOBSESSIONAL / ANTIBULIMIC
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
February 7, 2017
SUBMISSION CONTROL NO.: 201912
_phl-FLUOXETINE Product Monograph Page 2 of 51_
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
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
27
OVERDOSAGE
................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
.........................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
35
PHARMACEUTICAL INFORMATION
.........................................................................
35
CLINICAL TRIALS
.........................................................................................................
36
DETAILED PHARMACOLOGY
............................................