CO FENTANYL PATCH

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

FENTANYL

זמין מ:

COBALT PHARMACEUTICALS COMPANY

קוד ATC:

N02AB03

INN (שם בינלאומי):

FENTANYL

כמות:

25MCG

טופס פרצבטיות:

PATCH

הרכב:

FENTANYL 25MCG

מסלול נתינה (של תרופות):

TRANSDERMAL

יחידות באריזה:

5

סוג מרשם:

Narcotic (CDSA I)

איזור תרפויטי:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0123302014; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-05-17

מאפייני מוצר

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_CO _FENTANYL_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
N
_CO_ FENTANYL
Fentanyl Transdermal Patches (Matrix)
12 mcg/h
25 mcg/h
37 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
Opioid Analgesic
Cobalt Pharmaceuticals Company
Date of Revision:
6733 Mississauga Road, Suite 400
August 23, 2017
Mississauga, Ontario
L5N 6J5
Submission Control No.: 208560
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_CO _FENTANYL_ _
_Page 2 of 49_
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
..........................................................................................................
14
DRUG
INTERACTIONS
...........................................................................................................
17
DOSAGE
AND
ADMINISTRATION
.......................................................................................
18
OVERDOSAGE
.........................................................................................................................
25
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
26
STORAGE
AND
STABILITY...................................................................................................
28
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 29
PART II: SCIENTIFIC INFORMATION
................................................................................
31
PHARMACE