BAR-BUPRENORPHINE PATCH

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BUPRENORPHINE

Tersedia dari:

BARD PHARMACEUTICALS (1990) INC

Kode ATC:

N02AE01

INN (Nama Internasional):

BUPRENORPHINE

Dosis:

10MCG

Bentuk farmasi:

PATCH

Komposisi:

BUPRENORPHINE 10MCG

Rute administrasi :

TRANSDERMAL

Unit dalam paket:

100

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE PARTIAL AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0142241018; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-11-01

Karakteristik produk

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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
.......................................................