MYLAN-FENTANYL MATRIX PATCH

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FENTANYL

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

N02AB03

INN (Nama Antarabangsa):

FENTANYL

Dos:

100MCG

Borang farmaseutikal:

PATCH

Komposisi:

FENTANYL 100MCG

Laluan pentadbiran:

TRANSDERMAL

Unit dalam pakej:

5

Jenis preskripsi:

Narcotic (CDSA I)

Kawasan terapeutik:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0123302012; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-12-31

Ciri produk

1
PRODUCT MONOGRAPH
N
MYLAN-FENTANYL MATRIX PATCH
fentanyl transdermal system
12 mcg/h
25 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: April 5, 2019
Submission Control No.: 226168
2
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
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
23
OVERDOSAGE
.......................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 32
STORAGE AND STABILITY
.................................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 36
PART II: SCIENTIFIC INFORMATION
...............................................................................
38
PHARMACEUTICAL INFORMATION
.................................................................................
38
CLINICAL TRIALS
...