CO FENTANYL PATCH

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

FENTANYL

から入手可能:

COBALT PHARMACEUTICALS COMPANY

ATCコード:

N02AB03

INN（国際名）:

FENTANYL

投薬量:

75MCG

医薬品形態:

PATCH

構図:

FENTANYL 75MCG

投与経路:

TRANSDERMAL

パッケージ内のユニット:

5

処方タイプ:

Narcotic (CDSA I)

治療領域:

OPIATE AGONISTS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2018-05-17

製品の特徴

_ _
_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
_ _
_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