APO-FENTANYL MATRIX PATCH

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FENTANYL

Boleh didapati daripada:

APOTEX INC

Kod ATC:

N02AB03

INN (Nama Antarabangsa):

FENTANYL

Dos:

75MCG

Borang farmaseutikal:

PATCH

Komposisi:

FENTANYL 75MCG

Laluan pentadbiran:

TRANSDERMAL

Unit dalam pakej:

5 X 32.1 SQ CM

Jenis preskripsi:

Narcotic (CDSA I)

Kawasan terapeutik:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0123302013; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-07-12

Ciri produk

PRODUCT MONOGRAPH APO-FENTANYL MATRIX
fentanyl transdermal system
12 mcg/h
25 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
OPIOID ANALGESIC
Apotex Inc.
Date of Revision:
150 Signet Drive
April 29, 2019
Toronto, Ontario
M9L 1T9
Submission Control No.: 227068
Page 2 of 53
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
......................................................................................................................................
16
DRUG INTERACTIONS
.......................................................................................................................................
20
DOSAGE AND ADMINISTRATION
...................................................................................................................
22
OVERDOSAGE
.....................................................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................................
29
STORAGE AND STABILITY
...............................................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
............................................................................................................
32
DO