BAR-BUPRENORPHINE PATCH

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

BUPRENORPHINE

Inapatikana kutoka:

BARD PHARMACEUTICALS (1990) INC

ATC kanuni:

N02AE01

INN (Jina la Kimataifa):

BUPRENORPHINE

Kipimo:

20MCG

Dawa fomu:

PATCH

Tungo:

BUPRENORPHINE 20MCG

Njia ya uendeshaji:

TRANSDERMAL

Vitengo katika mfuko:

100

Dawa ya aina:

Narcotic (CDSA I)

Eneo la matibabu:

OPIATE PARTIAL AGONISTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0142241019; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-11-01

Tabia za bidhaa

_ _
_BAR-Buprenorphine (buprenorphine transdermal patch) _
_ _
_Page 1 of 71 _
_ _
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
_ _
_BAR-Buprenorphine (buprenorphine transdermal patch) _
_ _
_Page 2 of 71 _
_ _
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
.......................................................