SANDOZ FENTANYL PATCH

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FENTANYL

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

N02AB03

INN (Medzinárodný Name):

FENTANYL

Dávkovanie:

12MCG

Forma lieku:

PATCH

Zloženie:

FENTANYL 12MCG

Spôsob podávania:

TRANSDERMAL

Počet v balení:

5

Typ predpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0123302015; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2009-06-03

Súhrn charakteristických

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_Sandoz Fentanyl Patch _
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PRODUCT MONOGRAPH
N SANDOZ FENTANYL PATCH
Fentanyl Transdermal System
12 mcg/h
25 mcg/h
37 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
Sandoz Canada Inc.
Date of Revision: February 26, 2020
110 Rue de Lauzon
Boucherville, Quebec, Canada
J4B 1E6
Submission Control No.: 236309
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_Sandoz Fentanyl Patch _
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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
..........................................................................................................
17
DRUG
INTERACTIONS
...........................................................................................................
20
DOSAGE
AND
ADMINISTRATION
.......................................................................................
22
OVERDOSAGE
.........................................................................................................................
28
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
29
STORAGE
AND
STABILITY...................................................................................................
32
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
32
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 33
PART II: SCIENTIFIC INFORMATION
................................................................................
35
PHARMACEUTIC