ABSTRAL TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

FENTANYL (FENTANYL CITRATE)

Sẵn có từ:

PALADIN LABS INC.

Mã ATC:

N02AB03

INN (Tên quốc tế):

FENTANYL

Liều dùng:

100MCG

Dạng dược phẩm:

TABLET

Thành phần:

FENTANYL (FENTANYL CITRATE) 100MCG

Tuyến hành chính:

SUBLINGUAL

Các đơn vị trong gói:

10/30

Loại thuốc theo toa:

Narcotic (CDSA I)

Khu trị liệu:

OPIATE AGONISTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-06-29

Đặc tính sản phẩm

_ _
_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
...........................................................