ABSTRAL TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FENTANYL (FENTANYL CITRATE)

Доступна с:

PALADIN LABS INC.

код АТС:

N02AB03

ИНН (Международная Имя):

FENTANYL

дозировка:

100MCG

Фармацевтическая форма:

TABLET

состав:

FENTANYL (FENTANYL CITRATE) 100MCG

Администрация маршрут:

SUBLINGUAL

Штук в упаковке:

10/30

Тип рецепта:

Narcotic (CDSA I)

Терапевтические области:

OPIATE AGONISTS

Обзор продуктов:

Active ingredient group (AIG) number: 0123302012; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2018-06-29

Характеристики продукта

_ _
_ABSTRAL Product Monograph _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
N
ABSTRAL
®
Fentanyl citrate sublingual tablets
100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg fentanyl as
fentanyl citrate
Opioid Analgesic
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, Quebec H4M 2P2
Date of Preparation:
March 8, 2018
Version 7.0
Submission Control No: 210630
_ _
®
Registered trademark of Strakan International Limited
_ _
_ _
_ABSTRAL Product Monograph Page 2 of 64_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...........................................................