BAR-BUPRENORPHINE PATCH

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

BUPRENORPHINE

Sẵn có từ:

BARD PHARMACEUTICALS (1990) INC

Mã ATC:

N02AE01

INN (Tên quốc tế):

BUPRENORPHINE

Liều dùng:

15MCG

Dạng dược phẩm:

PATCH

Thành phần:

BUPRENORPHINE 15MCG

Tuyến hành chính:

TRANSDERMAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Narcotic (CDSA I)

Khu trị liệu:

OPIATE PARTIAL AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0142241009; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-11-01

Đặc tính sản phẩm

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_BAR-Buprenorphine (buprenorphine transdermal patch) _
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PRODUCT MONOGRAPH
N
BAR-BUPRENORPHINE
Buprenorphine Transdermal System
5, 10, 15 and 20 mcg/h
Manufacturer’s Standard
Opioid Analgesic
Bard Pharmaceuticals (1990) Inc.
575 Granite Court
Pickering, Ontario
L1W 3W8
DATE OF REVISION:
November 1, 2019
Submission Control No: 231026
BUTRANS
®
is a trademark of Purdue Pharma
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_BAR-Buprenorphine (buprenorphine transdermal patch) _
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_Page 2 of 71 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
............................................................................................
18
DRUG INTERACTIONS
............................................................................................
30
DOSAGE AND ADMINISTRATION
........................................................................
32
OVERDOSAGE
...........................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
...................................................... 38
STORAGE AND STABILITY
....................................................................................
43
SPECIAL HANDLING INSTRUCTIONS
................................................................. 43
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 43
AVAILABILITY OF DOSAGE FORMS
................................................................... 44
PART II: SCIENTIFIC INFORMATION
.......................................................