ABSTRAL TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FENTANYL (FENTANYL CITRATE)

Предлага се от:

PALADIN LABS INC.

АТС код:

N02AB03

INN (Международно Name):

FENTANYL

дозиране:

100MCG

Лекарствена форма:

TABLET

Композиция:

FENTANYL (FENTANYL CITRATE) 100MCG

Начин на приложение:

SUBLINGUAL

Броя в опаковка:

10/30

Вид предписание :

Narcotic (CDSA I)

Терапевтична област:

OPIATE AGONISTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2018-06-29

Данни за 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
...........................................................