TEVA-BUPRENORPHINE/NALOXONE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE); BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

N07BC51

INN (Tên quốc tế):

BUPRENORPHINE, COMBINATIONS

Liều dùng:

0.5MG; 2MG

Dạng dược phẩm:

TABLET

Thành phần:

NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5MG; BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2MG

Tuyến hành chính:

SUBLINGUAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Narcotic (CDSA I)

Khu trị liệu:

OPIATE PARTIAL AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0252216001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-12-17

Đặc tính sản phẩm

TEVA-BUPRENORPHINE/NALOXONE
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_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N TEVA-BUPRENORPHINE/NALOXONE
Buprenorphine and Naloxone Sublingual Tablets
Tablets, Buprenorphine (as Buprenorphine Hydrochloride) and Naloxone
(as
Naloxone Hydrochloride Dihydrate),
2 mg/0.5 mg and 8 mg/2 mg, sublingual
Teva Standard
Partial Opioid Agonist
and
Opioid Antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
April 18, 2016
Date of Revision:
January 25, 2022
Submission Control No.: 254725
_ _
TEVA-BUPRENORPHINE/NALOXONE
_ _
_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
3 Serious Warning and Precautions
01/2022
4 Dosage and Administration
01/2022
7 Warning and Precautions
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
P
EDIATRICS
....................................................................................................................................................
4
1.2
G
ERIATRICS
...................................................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
.....................................................................