NUCYNTA IR TABLET (IMMEDIATE RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE)

Sẵn có từ:

ENDO VENTURES LTD.

Mã ATC:

N02AX06

INN (Tên quốc tế):

TAPENTADOL

Liều dùng:

75MG

Dạng dược phẩm:

TABLET (IMMEDIATE RELEASE)

Thành phần:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 75MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Narcotic (CDSA I)

Khu trị liệu:

OPIATE AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152846006; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-02-13

Đặc tính sản phẩm

_Nucynta_
_®_
_ IR Product Monograph_
_ _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
NUCYNTA®
IR
Tapentadol (as tapentadol hydrochloride) immediate-release tablets
50 mg, 75 mg, and 100 mg tablets
Tapentadol (as tapentadol hydrochloride)
Opioid Analgesic
_ _
Endo Ventures Ltd
First Floor, Minerva, Simmonscourt Road
Ballsbridge, Dublin 4
Ireland
Date of Initial Authorization:
January 13, 2012
Date of Revision:
October 15, 2021
IMPORTER/DISTRIBUTOR
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
Montreal, H4M 2P2
Quebec, Canada
_ _
Submission Control Number: 247865
All trademarks used under license
_ _
_Nucynta® IR Product Monograph_
_ _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions
03/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1.
INDICATIONS
..............................................................................................................
4
1.1 Pediatrics (<18
years).............................................................................................
4
1.2 Geriatrics (≥65 years of
age)...................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4.
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1 Dosing Considerations
...........................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
...................................