MINT-FLUOXETINE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE)

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N06AB03

INN (International Name):

FLUOXETINE

Dosering:

10MG

Lægemiddelform:

CAPSULE

Sammensætning:

FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

Active ingredient group (AIG) number: 0116847003; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-02-24

Produktets egenskaber

_MINT-FLUOXETINE (Fluoxetine Capsules USP) _
_ _
_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-FLUOXETINE
Fluoxetine Capsules USP
Capsules, 10 mg and 20 mg fluoxetine (as fluoxetine hydrochloride),
Oral
Antidepressant / Antiobsessional / Antibulimic
MINT Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario,
L5T 2M3
Date of Initial Authorization:
February 24, 2012
Date of Revision:
February 21, 2022
Submission Control Number: 256561
_MINT-FLUOXETINE (Fluoxetine Capsules USP) _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
02/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
02/2022
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
......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
......................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment.............................................................
6
4.4
Administration....................