MYLAN-FENTANYL MATRIX PATCH
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-04-2019
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Aktiva substanser:
FENTANYL
Tillgänglig från:
MYLAN PHARMACEUTICALS ULC
ATC-kod:
N02AB03
INN (International namn):
FENTANYL
Dos:
50MCG
Läkemedelsform:
PATCH
Sammansättning:
FENTANYL 50MCG
Administreringssätt:
TRANSDERMAL
Enheter i paketet:
5
Receptbelagda typ:
Narcotic (CDSA I)
Terapiområde:
OPIATE AGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0123302011; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2018-12-31
Produktens egenskaper
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
...
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