OLEPTRO TABLET (EXTENDED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

TRAZODONE HYDROCHLORIDE

Предлага се от:

ANGELINI PHARMA INC

АТС код:

N06AX05

INN (Международно Name):

TRAZODONE

дозиране:

150MG

Лекарствена форма:

TABLET (EXTENDED-RELEASE)

Композиция:

TRAZODONE HYDROCHLORIDE 150MG

Начин на приложение:

ORAL

Броя в опаковка:

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

Вид предписание :

Prescription

Терапевтична област:

SEROTONIN MODULATORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2011-01-19

Данни за продукта

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
.....................