MYLAN-FENTANYL MATRIX PATCH

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FENTANYL

可用日期:

MYLAN PHARMACEUTICALS ULC

ATC代码:

N02AB03

INN（国际名称）:

FENTANYL

剂量:

100MCG

药物剂型:

PATCH

组成:

FENTANYL 100MCG

给药途径:

TRANSDERMAL

每包单位数:

5

处方类型:

Narcotic (CDSA I)

治疗领域:

OPIATE AGONISTS

產品總結:

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

授权状态:

CANCELLED POST MARKET

授权日期:

2018-12-31

产品特点

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
...