APO-FENTANYL MATRIX PATCH

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FENTANYL

Prieinama:

APOTEX INC

ATC kodas:

N02AB03

INN (Tarptautinis Pavadinimas):

FENTANYL

Dozė:

50MCG

Vaisto forma:

PATCH

Sudėtis:

FENTANYL 50MCG

Vartojimo būdas:

TRANSDERMAL

Vienetai pakuotėje:

5 X 21.4 SQ CM

Recepto tipas:

Narcotic (CDSA I)

Gydymo sritis:

OPIATE AGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0123302011; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2018-02-20

Prekės savybės

PRODUCT MONOGRAPH APO-FENTANYL MATRIX
fentanyl transdermal system
12 mcg/h
25 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h
OPIOID ANALGESIC
Apotex Inc.
Date of Revision:
150 Signet Drive
April 29, 2019
Toronto, Ontario
M9L 1T9
Submission Control No.: 227068
Page 2 of 53
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
......................................................................................................................................
16
DRUG INTERACTIONS
.......................................................................................................................................
20
DOSAGE AND ADMINISTRATION
...................................................................................................................
22
OVERDOSAGE
.....................................................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................................
29
STORAGE AND STABILITY
...............................................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
............................................................................................................
32
DO