OLEPTRO TABLET (EXTENDED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

TRAZODONE HYDROCHLORIDE

Prieinama:

ANGELINI PHARMA INC

ATC kodas:

N06AX05

INN (Tarptautinis Pavadinimas):

TRAZODONE

Dozė:

150MG

Vaisto forma:

TABLET (EXTENDED-RELEASE)

Sudėtis:

TRAZODONE HYDROCHLORIDE 150MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

4/7/10/11/30/90/500

Recepto tipas:

Prescription

Gydymo sritis:

SEROTONIN MODULATORS

Produkto santrauka:

Active ingredient group (AIG) number: 0115713003; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2011-01-19

Prekės savybės

OLEPTRO
™
(Trazodone Hydrochloride Extended-Release Caplets)
Page 1 of 37
PRODUCT MONOGRAPH
PR
OLEPTRO
™
Trazodone Hydrochloride Extended-Release Caplets
150 and 300 mg
Antidepressant
Angelini Pharma Inc.
8322 Helgerman Court
Gaithersburg, MD 20877
USA
Date of Preparation:
OCTOBER 7, 2014
SUBMISSION CONTROL NO: 177639
This Product Monograph is the exclusive property of Angelini Pharma
Inc. It may be not copied
in whole or in part without the written permission of Angelini Pharma
Inc.
OLEPTRO is a trademark of Angelini Pharma Inc.
© 2013 Angelini Pharma Inc.
OLEPTRO
™
(Trazodone Hydrochloride Extended-Release Caplets)
Page 2 of 37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................